[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumor":638},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,292,0,25,[9,48,75,100,122,131,157,189,211,230,253,275,295,311,328,345,373,413,442,461,484,498,520,548,572],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053593",false,"NCT07489378","NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors","* INCLUSION CRITERIA:\n* History of newly diagnosed (within 1 year of diagnosis) very rare solid tumor (defined as an estimated 2 incident cases per million per year).\n* Age \\>= 1 month and \\\u003C= 39 years at the time of diagnosis.\n* Participants must have established care with a local treating physician.\n* Ability of the participant, parent\u002Fguardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Diagnosis of any of the following at any time:\n\n  * Ewing Sarcoma\n  * Osteosarcoma\n  * Rhabdomyosarcoma\n  * Diffuse midline glioma (H3K27 altered)\n  * Atypical teratoid rhabdoid tumor\n  * Pleuropulmonary blastoma\n  * Common adult cancers that occur in pediatric\u002FAYA populations (i.e., colorectal cancer, breast cancer)\n* The participant is unlikely to comply with the terms of the protocol.","ALL","1 Month","120 Years",{"count":19,"type":20},4000,"ESTIMATED","OBSERVATIONAL","Background:\n\nAll childhood cancers are rare, but some are called very rare. Very rare cancers are diagnosed in 2 or fewer out of 1 million people each year. Researchers want to gather data so they can learn more about these very rare cancers. They hope to use the data to develop future treatments.\n\nObjective:\n\nTo gather data for a registry of very rare cancers found in children, teens, and young adults.\n\nEligibility:\n\nPeople aged 1 month to 39 years newly diagnosed (within the past year) with a very rare cancer.\n\nDesign:\n\nParticipation will be by phone or email. No clinic visits are required.\n\nResearchers will look at the participant s medical records. They will ask for samples of tumor tissue that were already removed. They will use the samples for genetic testing. The results of these tests will be sent to the participant s own doctors.\n\nSome participants will be asked for saliva or cheek swab samples. They will receive a kit in the mail. They will spit into a tube or swab the inside of their cheek. They will mail the sample back to the lab.\n\nParticipants will fill out questionnaires once a year for 5 years. They will answer questions about:\n\nFamily history, such as other cancers in the family and their income, work, and education.\n\nDemographics, such as their gender, nationality, ethnicity, education, and work history.\n\nSymptoms and treatment for their cancer. This may include level of pain, and emotional and physical well-being.\n\nParticipants data will be added to a secure database for other researchers. Their data will be anonymous.",[24,25,26,27,28],"Very Rare Tumors","Very Rare Cancers","Other Solid Tumors","Solid Tumor","Pediatric Rare Tumors",[30,31,32,33,34],"Longitudinal Study","Registry","Patient Reported Outcomes","Family History","Molecular Characterization","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":20},"2026-07-16",{"date":43,"type":20},"2037-04-01",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":4,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100053661","NCT05250284","The Intersection of Oncology Care and Worker Well-Being","Inclusion Criteria:\n\n* Males\n* Ages 21 to 70\n* Newly diagnosed with a first primary solid tumor\n* colorectal, lung, and head and neck\n* Currently employed (defined as working 10+ hours per week) with the intention to continue working or return to work\n* Within 2 months of initiating infusion chemotherapy, oral agent, or radiation therapy","MALE","21 Years","70 Years",{"count":57,"type":20},400,"The goals of this study will be a greater understanding of cancer patients' well-being experience through the care\u002Ftreatment continuum. An important aspect of the study is an understanding of work- and treatment-related challenges experienced by low-income men, many of whom will be Latino. At the 12-month observation period, the investigators will learn whether these men work long-term and how work status relates to well-being.",[27],[61,62,63,64,65,66],"Newly Diagnosed Primary Solid Tumor","Men","Employed","Chemotherapy","Oral Agent","Radiation Therapy",{"date":38,"type":39},{"date":69,"type":39},"2022-04-04",{"date":71,"type":20},"2027-08-31",{"name":73,"class":74},"University of Colorado, Denver","OTHER",{"id":76,"slug":4,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":47},"100053430","NCT07698587","A Phase Ib\u002FII Study of BM230 in Combination With PD-1 Inhibitor for HER2-related Advanced Solid Tumors","A Phase Ib\u002FII, Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BM230 in Combination With PD-1 Inhibitor in Patients With HER2-Related Advanced Solid Tumors","Inclusion Criteria:\n\ncommon inclusion criteria (Phase Ib and Phase II) (Criteria 1 to 10)\n\n1. Informed of the study before the start of the study and voluntarily sign their name and date on the informed consent form (ICF)\n2. Males and Females≥18 years old（at the time consent is obtained）\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1\n4. Life expectancy of ≥ 3 months\n5. Adequate organ and bone marrow function, defined as:\n\n   * Bone marrow function: hemoglobin ≥ 90 g\u002FL (have not received blood transfusion or erythropoietin treatment within 14 days before the first dose); absolute neutrophil count ≥ 1.5×109\u002FL (have not received granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor treatment within 14 days before the first dose); platelet count ≥ 100×109\u002FL ((have not received platelet transfusion, thrombopoietin, or interleukin-11 treatment within 14 days before the first dose)\n   * Coagulation function: activated partial thromboplastin time and international normalized ratio ≤ 1.5 × ULN\n   * Liver function (based on the normal range at the study site): TBIL ≤ 1.5 × ULN if no demonstrable liver lesion(s) (primary or metastases), \\\u003C 4 × ULN for patients with Gilbert syndrome, or ≤ 3 × ULN in the presence of liver lesion(s); ALT and AST ≤ 3 × ULN if no demonstrable liver lesion(s) (primary or metastases), or ≤ 5 × ULN in the presence of liver lesion(s)\n   * Renal function (based on the normal range at the study site): creatinine clearance (CrCl) calculated by the Cockcroft-Gault formula ≥ 50 mL\u002Fmin, or 24-h urine CrCl ≥ 50 mL\u002Fmin\n   * Cardiac function: LVEF ≥ 50%\n6. Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug; a negative pregnancy test must be obtained within 7 days before the first dose. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug\n7. Able and willing to comply with protocol visits and procedures\n8. Have HER2 expression (IHC 1+, 2+, or 3+) determined by immunohistochemistry, or HER2 amplification (NGS report indicating HER2 amplification), or (for NSCLC) HER2 exon 8, exon 19, or exon 20 mutations. For Australia, only patients with cancer types covered by Australian Medicare for HER2 expression, amplification, or mutation testing, and\u002For patients with known HER2 expression, amplification, or mutation identified via any other program are to be considered\n9. Willing to provide archived or fresh tumor tissue samples. Patients who are unable to provide tumor samples or have insufficient samples may be eligible on a case-by-case basis after discussion with the sponsor\n10. Have at least 1 measurable target tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n\n    Additional inclusion criteria for Phase II (Criteria 11 to 14)\n11. Cohort A: Unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors in adult patients:\n\n    * Patients with advanced colorectal cancer who have experienced disease progression following prior treatment with fluoropyrimidines, oxaliplatin, and irinotecan\n    * Patients with other advanced solid tumors who have experienced disease progression after prior treatment and for whom no satisfactory alternative treatment is available\n12. Cohort B: Esophageal squamous cell carcinoma:\n\n    * Locally advanced or metastatic esophageal squamous cell carcinoma that has progressed or is intolerant following first-line standard chemotherapy\n13. Cohort C: Urothelial carcinoma:\n\n    * Locally advanced or metastatic urothelial carcinoma that has progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy, or after failure of platinum-based chemotherapy\n14. Other tumor types:\n\n    * Locally advanced or metastatic advanced solid tumors that have progressed or are intolerant following first-line standard chemotherapy, including cholangiocarcinoma, endometrial carcinoma, cervical cancer, ovarian cancer, etc\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will NOT be included in the study:\n\n1. Have received prior treatment with anti-HER2 antibody agents (excluding HER2 ADC agents).\n2. Preexisting autoimmune disease (except for patients with vitiligo) needing treatment with systemic immunosuppressive therapy for more than 28 days within the last 3 years, or clinically relevant immuno-deficiency diseases (eg, agammaglobulinemia or congenital\n3. Multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other curatively treated solid tumors (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery)\n4. Insufficient washout period of the prior anticancer treatment before the first dose of the investigational product, defined as follows:\n\n   * Anti-neoplastic treatments such as chemotherapy, biological therapy, endocrine therapy and immunotherapy within 3 weeks before the first dose\n   * Palliative radiotherapy for tumors within 2 weeks before the first dose\n   * Endocrine therapy for tumors within 2 weeks before the first dose\n   * Chinese herbal medicine or Chinese patent medicine for tumor indications within 2 weeks before the first dose\n   * Other unmarketed investigational drugs or treatments within 4 weeks before the first dose (fluoropyrimidines and small-molecule targeted drugs: within 2 weeks before the first dose or within 5 half-lives of the drug, whichever is shorter)\n5. Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose or are expected to undergo major surgery during the study\n6. Has a history of allogeneic hematopoietic stem cell transplantation or organ transplantation\n7. Received systemic corticosteroids (defined as \\> 10 mg\u002Fday of prednisone or equivalent) or other immuno-suppressive therapy within 2 weeks before the first dose. The following are exceptions to this criterion:\n\n   * Intranasal, inhaled, topical steroids, topical corticosteroids or local steroid injections (eg, intra-articular injections)\n   * Systemic steroids at physiological doses as replacement therapy (eg, physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency)\n   * Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)\n8. Received any live vaccines within 4 weeks before the first dose or intend to receive live vaccines during the study\n9. Have experienced any Grade ≥3 immune-related adverse event (irAE), or a Grade \\\u003C3 immune-related adverse event that occurred within 6 months prior to enrollment and has not yet resolved.\n10. A history of leptomeningeal disease; or presence of unstable central nervous system (CNS) metastases. Stability is defined as having undergone surgical resection and\u002For radiation therapy for CNS metastases at least 28 days before the first dose, and meeting all of the following criteria after completion of treatment:\n\n    * No neurological symptoms, or symptoms are stable and ≤ Grade 1\n    * No progression of treated lesions and no new lesions on contrast-enhanced CT or MRI within 28 days before the first dose\n    * No or mild cerebral edema on imaging at screening, without requirement for systemic corticosteroids or anticonvulsants\n11. Uncontrolled or clinically significant cardiovascular disease, including but not limited to:\n\n    * History of symptomatic CHF (New York Heart Association \\[NYHA\\] class II-IV) or any arterial thromboembolic events (e.g., myocardial infarction, unstable angina, cerebrovascular accident, transient ischaemic attack) within 6 months before the first dose\n    * Uncontrolled hypertension, defined as systolic blood pressure (SBP) \\>160 mmHg and\u002For diastolic blood pressure (DBP) \\>100 mmHg despite antihypertensive therapy\n    * Serious cardiac arrhythmia requiring treatment\n    * The QT interval corrected by the Fridericia formula (QTcF) is prolonged to \\> 470 ms\n12. Active haemorrhage with significant clinical significance\n13. Uncontrolled third-space fluid (eg, pleural effusions, ascites, pericardial effusions) that requires repeated drainage\n14. Uncontrolled or unstable systemic diseases, including diabetes mellitus, hepatic cirrhosis, interstitial lung disease, and obstructive lung disease, by the investigator's discretion\n15. Uncontrolled infection that requires systemic therapy within 1 week before the first dose\n16. Active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis infection. Active HBV is defined as hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) positive, and HBV DNA level above ULN at the study site; active HCV is defined as positive hepatitis C antibody and HCV RNA level above ULN at the study site; active HIV is defined as positive HIV antibody; active syphilis is defined as positive Treponema pallidum laboratory test. However, patients with well-controlled HIV (as judged by the investigator) may be considered eligible\n17. Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion\u002Fexclusion criteria with the exception of alopecia (any grade), pigmentation (any grade), and peripheral neuropathy (Grade ≤2). Patients with irreversible toxicity (eg, hearing loss) that is reasonably not expected to be aggravated by the study drug can be enrolled after discussion with the sponsor\n18. A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other mAbs\n19. Has a history of ≥ Grade 3 hypersensitivity or allergic reaction to IgG4 monoclonal antibodies and\u002For their excipients, or to the PD-1 inhibitor used in the corresponding cohort and\u002For its excipients.\n20. Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 7 days before the first dose\n21. Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance\u002Falcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results","18 Years",{"count":83,"type":20},90,"INTERVENTIONAL",[86,87],"PHASE1","PHASE2","This study is a multicenter, non-randomized, open-label, Phase Ib\u002FII combination therapy trial. The trial consists of two parts: Part 1 (Phase Ib), dose-escalation of combination therapy, followed by Part 2 (Phase II), tumor-type exploration of combination therapy. This study will evaluate the RP2D, safety, tolerability, and preliminary efficacy of BM230 in combination with PD-1 inhibitor in patients with HER2-related solid tumors (including but not limited to colorectal cancer, esophageal squamous cell carcinoma, urothelial carcinoma, cholangiocarcinoma, endometrial cancer, cervical cancer, ovarian cancer, etc.).",[27],"NOT_YET_RECRUITING","2026-07-07",{"date":38,"type":39},{"date":94,"type":20},"2026-07",{"date":96,"type":20},"2029-12",{"name":98,"class":99},"Suzhou Biomissile Pharmaceuticals Co., Ltd.","INDUSTRY",{"id":101,"slug":4,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":84,"phases":108,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":47},"100645281","NCT07680582","An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors","An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors","Key Inclusion Criteria:\n\n1. ≥18 years of age at time of informed consent\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1\n3. Life expectancy of ≥6 months\n4. Patient diagnosed with solid tumors and is receiving perioperative and\u002For adjuvant anti-cancer therapy, or patients with advanced solid tumors\n5. No evidence of disease progression per investigator within 28 days before the first dose of study intervention\n6. Sufficient organ function\n7. Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose.\n\nKey Exclusion Criteria:\n\n1. For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously\n2. Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer\n3. Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.\n4. Presence of active infections\n5. History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment\n6. Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab.",{"count":107,"type":20},60,[109],"EARLY_PHASE1","The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine. In addition, the antitumor activity of ABO2109 will be assessed during both dose exploration and expansion stages, the accumulative data will support the clinical development of ABO2109.",[27],[113],"Ruijin Hospital","2026-07-01",{"date":116,"type":39},"2026-07-02",{"date":118,"type":39},"2026-06-09",{"date":120,"type":20},"2031-02-09",{"name":113,"class":74},{"id":123,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":125,"keywords":126,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":129,"leadSponsor":130,"locationsCount":47},"100630569",{"count":19,"type":20},[24,25,26,27,28],[30,31,32,33,34],{"date":116,"type":39},{"date":91,"type":20},{"date":43,"type":20},{"name":45,"class":46},{"id":132,"slug":4,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":15,"minAge":54,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":84,"phases":139,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100434863","NCT04942717","Adapting for Latinx Populations an Intervention That Involves Discussing and Sharing Patients' Health-Related Values","Communicating With Oncology Nurses About Values From the Outset (CONVO): An Innovative Primary Palliative Care Intervention in English and Espanol","Inclusion Criteria:\n\n* All participants will be adults (age ≥ 21) providing informed verbal consent. We seek a waiver of signed consent, which will allow use of virtual communication during the COVID-19 pandemic period.\n* Patients will be eligible as key informants in the translation\u002Ftranscreation process (Aim 1) if they are receiving medical oncology care for a solid tumor malignancy at RLC, SBH, or Jacobi and speak Spanish as their preferred language. In addition, English-speaking Latinx patients will be eligible to participate in interviews based on the back-translated (Spanish-to-English) version of the Guide\n\n  * We are focusing on patients with solid tumors rather than hematologic malignancies because 1) patients in the latter group may be receiving initial oncologic treatment in the hospital, whereas our study staff will be based at a distance from the hospital in the ambulatory clinics; 2) the trajectory, patient characteristics, and other aspects of hematologic malignancies tend to be different from solid tumor malignancies such that it would be more difficult to understand the overall impact of the intervention if patients with both types of malignancies w ere included.\n* Spanish-speaking family\u002Fother informal caregivers (collectively referred to as \"family\") who accompany participating patients to clinic will also be eligible to participate in interviews as part of the Aim 1 translation\u002Ftranscreation process. These will be individual interviews, conducted separately for patient and family participants.\n* Clinicians eligible for participation in the transcreation will be oncology physicians, nurses and other key clinical staff (e.g. social workers, advance practice providers, etc.) at RLC and other MSK sites who are Latinx and\u002For whose practice includes \\>20% Latinx patients.\n* Site leaders at SBH, Jacobi, and RLC with administrative responsibility for medical oncology will be eligible as key informants in transcreation of CONVO.\n* For the Aim 2 pilot trial, patients will be eligible if they are receiving systemic chemotherapy at SBH or Jacobi for a solid tumor; identify as Latinx; and speak English and\u002For Spanish. Family and\u002For informal caregivers who accompany the patient and speak English and\u002For Spanish will also be eligible (if the patient opts to include the family and\u002For informal caregiver in the CONVO discussion).\n* Nurses providing outpatient oncology care in chemotherapy areas at SBH or Jacobi will be eligible to participate in the pilot trial.\n\nExclusion Criteria:\n\n* Inability to understand consent procedure in either English or Spanish will be an exclusion. (The consenting professional will be bilingual \\[English\u002FSpanish\\] and able to explain and obtain consent in either language.)",{"count":138,"type":20},234,[140],"NA","The purpose of this study is to translate and tailor for Latinx participants a program called Communicating with Oncology Nurses about Values from the Outset (CONVO). In CONVO, routine cancer care for each participant includes a discussion between the nurse and participant about the participant's health-related values.",[27,143,144],"Solid Tumor, Adult","Solid Tumor, Unspecified, Adult",[146,147,27,148,149],"Spanish speaking","Latinx","20-539","Memorial Sloan Kettering Cancer Center",{"date":116,"type":39},{"date":152,"type":39},"2021-06-18",{"date":154,"type":20},"2027-06-18",{"name":149,"class":74},5,{"id":158,"slug":4,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":84,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100468651","NCT05382559","A Study of ASP3082 in Adults With Advanced Solid Tumors","A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation","Inclusion Criteria:\n\n* Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented Kirsten rat sarcoma viral oncogene homolog \\[KRAS\\] G12D mutation and has received prior standard therapy and the investigator does not see any further clinical benefit from continuing such targeted therapy, or is ineligible to receive standard approved therapies (no limit to the number of prior treatment regimens).\n* For the ASP3082 monotherapy escalation cohorts, participants with solid tumor malignancies are allowed to be enrolled. Participants with other known KRAS G12 mutations will not be eligible for the study\n* For ASP3082 combination therapy with Nab-P+GEM or FOLFIRINOX or NALRIFOX: Participant must have mPDAC that has not been previously treated with chemotherapy. If a participant received (neo)adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the (neo)adjuvant therapy.\n* Participant consents to provide tumor specimen in a tissue block or unstained serial slides or a tumor biopsy (core needle biopsy or excision) obtained after the last interventional treatment, but prior to start of study intervention. Participant also consents to provide a sample for tumor biopsy during the treatment period as indicated in the study protocol. If a participant cannot provide a fresh tissue biopsy sample, the site should consult with the sponsor\u002Fstudy medical monitor.\n* Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participant has an ECOG performance status of 0, 1 or 2 for dose escalation, and 0 or 1 for dose expansion.\n* Participant's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to initiation of study intervention administration.\n* Participant has completed any radiotherapy (including stereotactic radiosurgery) at least 14 days prior to the start of study intervention administration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids (NOTE: Physiologic replacement dose of hydrocortisone or its equivalent \\[defined as up to 30 mg per day of hydrocortisone, 2 mg per day of dexamethasone, or up to 10 mg per day of prednisone\\] is permitted), and not have active radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\\\u003C= 2 weeks of radiotherapy) to non-central nervous system disease.\n* Participant's adverse events \\[AEs\\] (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to start of study intervention (or prior to staring SoC chemotherapy, for first line (1L) participants receiving Nab-P+GEM FOLFIRINOX or NALIRIFOX.\n* Participant has adequate organ function as indicated by protocol laboratory value parameters (If a participant has received a recent blood transfusion, the laboratory tests must be obtained \\>= 14 days after any blood transfusion.).\n* Female participant is not pregnant, confirmed by pregnancy test and medical evaluation by interview, and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP).\n  * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after study intervention administration.\n  * EU only: For combination therapy with carboplatin, follow contraception guidelines from the time of informed consent through at least 7 months after the final dose of carboplatin.\n  * South Korea only: For combination therapy with oxaliplatin, follow contraception guidelines from the time of informed consent through at least 15 months after the final dose of oxaliplatin. For combination therapy with cisplatin, follow contraception guidelines from the time of informed consent through at least 14 months after the final dose of cisplatin.\n* Female participant must agree not to breastfeed starting at screening and throughout the study period and for 6 months after study intervention administration.\n* Female participant must not donate ova starting at first dose of study intervention and throughout the study period and for 6 months after study intervention administration.\n* Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 3 months after study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 3 months after study intervention administration.\n* South Korea only: For combination therapy with oxaliplatin, follow contraception guidelines from the time of informed consent through at least 12 months after the final dose of oxaliplatin. For combination therapy with cisplatin, follow contraception guidelines from the time of informed consent through at least 11 months after the final dose of cisplatin.\n* Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 3 months after study intervention administration.\n* Participant agrees not to participate in another interventional study while receiving study intervention (Participants who are currently in the follow-up period of an interventional clinical trial are allowed).\n* For ASP3082 Combination Therapy with Pembrolizumab (Cohort G), or Platinum-based Chemotherapy + Pemetrexed +\u002F- Pembrolizumab (Cohort H): Participant must have pathologically documented locally advanced or metastatic (unresectable Stage IIIB-IV) non-small cell lung cancer (NSCLC) (Note: for Cohort H only, the tumor must be non-squamous NSCLC) with KRAS G12D mutation and\n\n  * have received prior platinum-containing chemotherapy (safety lead-in only) or\n  * have never received systemic therapy (up to 1 cycle of SoC pembrolizumab \\[defined as one 21-day cycle of 200 mg\\] in Cohort G and up to 1 cycle of SoC platinum-based chemotherapy ± pembrolizumab \\[defined as one 21-day cycle of 200 mg\\] or pembrolizumab \\[defined as one 21-day cycle of 200 mg\\] in Cohort H is permitted prior to Screening, provided a 21-day washout occurs before C1D1) for locally advanced or metastatic NSCLC with no oncogenic driver mutations. Participants who received adjuvant or neoadjuvant platinum-based chemotherapy and developed recurrent or metastatic disease more than 12 months after completing therapy may be enrolled.\n\nExclusion Criteria:\n\n* Participant has received investigational therapy within 21 days or 5 half-lives, whichever is shorter, prior to start of study intervention.\n* Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with asymptomatic, treated CNS metastases are eligible.\n* Participant has leptomeningeal disease as a manifestation of the current malignancy.\n* Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.\n* Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.\n* Participant with active hepatitis B (including acute hepatitis B virus \\[HBV\\] or chronic HBV) or hepatitis C virus \\[HCV\\] (ribonucleic acid \\[RNA\\] detected by qualitative assay). HCV RNA testing is not required in participants with negative HCV antibody testing.\n* Participant has a known history of human immunodeficiency virus \\[HIV\\] infection. No HIV testing is required unless mandated by a local health authority.\n* Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study intervention, left ventricular ejection fraction (LVEF) \\\u003C 50% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO) or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker, or long QT syndrome.\n* Participant has a corrected QT interval (single electrocardiogram \\[ECG\\]) using Fridericia's formula (QTcF) \\> 450 milliseconds (msec) (men) or \\>470 msec (women) during screening.\n* Participant has received prior treatment with a specific KRAS G12D inhibitor\u002Fdegrader or pan-RAS inhibitor\u002Fdegrader targeting KRAS G12D. Participants who received prior treatment with a KRAS G12D inhibitor\u002Fdegrader are eligible for the ASP3082 combination therapy cohort.\n* Participant has an active infection requiring intravenous antibiotics within 14 days prior to study intervention.\n* Participant is expected to require another form of antineoplastic therapy while on study treatment.\n* Participant has any condition which makes the participant unsuitable for study participation (such as psychiatric illness\u002Fsocial situations that would limit compliance with study requirements).\n* Participant has had major surgery within 4 weeks prior to first dose of study intervention.\n\nFor ASP3082 Combination Therapy:\n\n* Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab.\n* History of interstitial lung disease requiring systemic steroid treatment. Note that a participant with resolved pulmonary infections or radiation pneumonitis is eligible.",{"count":164,"type":20},681,[86],"This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D.\n\nThis study will be in 2 parts.\n\nIn Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2.\n\nIn Part 2, ASP3082 will be given in by itself, or in combination with the other study treatments.\n\nStudy treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.",[27],[27,169,170,171,172,173,174,175,176,177,178],"Cancer","Malignancy","Metastasis","Pharmacokinetics","setidegrasib","ASP3082","KRAS G12D","NSCLC","CRC","PDAC","2026-06-29",{"date":181,"type":39},"2026-06-30",{"date":183,"type":39},"2022-06-08",{"date":185,"type":20},"2028-12-31",{"name":187,"class":99},"Astellas Pharma Inc",55,{"id":190,"slug":4,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":195,"sex":53,"minAge":81,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":84,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":207,"leadSponsor":209,"locationsCount":47},"100645244","NCT07682337","Study of Single and Multiple Oral Doses of SCB0020160 in Healthy Adult Male Subjects","A First-in-Human, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Food Effect of SCB0020160 After Oral Administration in Healthy Adult Male Subjects","Inclusion Criteria:\n\n* Healthy adult male volunteers in the opinion of the principal investigator or delegate, aged 18 to 65 years at screening\n* Body weight more Than or equals to 45.0 kilograms per square meter at screening, with a body mass index (BMI) of more than or equals to18.0-kilogram Meter square and less than or equals to 32.0 Kilograms per meter square\n\n  * Body Mass Index (BMI, kilograms per square meter.) = Weight (kilogram)\u002F\\[Height square meter\\]\n* Eligible to participate in the study based on the results of physical examination, clinical laboratory tests, history taking, and other examinations performed at screening, as determined by the principal investigator or delegate\n* Has voluntarily decided to participate and provided written or electronic consent to comply with the precautions after receiving a full explanation of the study and fully understanding it\n\nExclusion Criteria:\n\n* Has a history of or currently has any disease, including clinically significant hepatobiliary (severe liver impairment, viral hepatitis, etc.), renal (severe renal impairment, etc.), neurological, immunological, respiratory, digestive, endocrine, hematologic and oncologic, cardiovascular (Torsades de pointes, etc.), urological, psychiatric (mood disorders, obsessive compulsive disorder, etc.), and sexual function disorders\n* Has a history of or currently has a gastrointestinal disease (Crohn's disease, ulcerative colitis, etc.) that may affect the safety and pharmacokinetic evaluation of the investigational product, or has a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery)\n* Has a history of hypersensitivity to the active pharmaceutical ingredient and components of the investigational product, drugs in the same class as the active pharmaceutical ingredient, or other drugs (aspirin, antibiotics, etc.)\n* Has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption\n* Has any of the following results in vital signs measured in a sitting position after resting for at least 5 minutes at screening\n* Systolic blood pressure more than 80 millimeters of mercury or greater than or equal to140 mmHg\n* Diastolic blood pressure less than 45 millimeters of mercury or greater than or equal to140 mmHg 90 millimeters of mercury\n* Pulse rate less than 45 beats\u002Fmin or \\> 105 beats\u002Fmin\n* Has any of the following results in the 12-lead electrocardiogram measured in a semi-supine position after resting for at least 5 minutes at screening, or has clinically significant rhythm findings\n* QTcF less than 450 msec\n* Has any of the following results in the screening clinical laboratory tests\n* Estimated Glomerular Filtration Rate (eGFR) (CKD-EPI equation) \\\u003C 90 mL\u002Fmin\u002F1.73 m²\n* Fasting serum glucose more than 5.4 millimoles per liter. or less than 3.0 millimoles per liter.\n* AST or ALT 1.5 X the upper limit of normal (ULN)\n* Total cholesterol less than 5.5 millimoles per liter\n* Triglyceride less than 2.0 millimoles per liter.\n* Drinks alcohol persistently (less than 21 units\u002Fweek, 1 unit = 10 gram = 12.5 milli liter of pure alcohol) or is unable to refrain from alcohol consumption from 3 days prior to the expected first dose of the investigational product until the end of the study\n* Tested positive for the breath alcohol test at screening or at check-in on D-1 10) Smokers (However, those who quit smoking 3 months prior to the expected first dose of the investigational product may be eligible as subjects)\n* Tested positive for the urine cotinine test at screening or at check-in on D-1, even if they do not smoke\n* Has taken any prescribed drugs or herbal medicines within 2 weeks prior to the expected first dose, or has taken any over-the-counter (OTC) drugs, health functional foods including liver supplements, or vitamins within 1 week (However, they may participate in the study if the investigator deems their other conditions appropriate), or is expected to take any of the said agents\n* Has taken drugs that induce drug-metabolizing enzymes, such as barbiturates, or drugs that inhibit drug metabolism, such as clarithromycin, within 1 month prior to the expected first dose\n* Has a history of alcohol or drug abuse, or has shown a positive result for abused drugs in a urine drug test at screening or at check-in on D-1\n* Has participated in another study (including bioequivalence studies) and received an investigational product within 3 months prior to the first dose\n* Has donated whole blood within 2 months, donated blood components within 1 month, or received a blood transfusion within 1 month prior to the expected first dose\n* Has persistently consumed excessive amounts of caffeine (\\> 5 units\u002Fday, 1 unit = 80 mg of caffeine), or is unable to refrain from consuming caffeine-containing foods (coffee, tea (black tea, green tea, etc.), carbonated beverages, coffee-flavored milk, health tonics, energy drinks, etc.) from 3 days prior to the expected first dose of the investigational product until the end of the study\n* Has consumed grapefruit, grapefruit juice, or grapefruit-containing foods from 3 days prior to the expected first dose of the investigational product until the end of the study, or is unable to refrain from consuming grapefruit-containing foods during this period\n* Has unusual eating habits (e.g., consuming more than 1L of grapefruit juice per day) or is unable to consume the standard diet provided by the study site during the inpatient period\n* Tested positive for serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)\n* Subjects who, or whose spouse (or partner) is a woman of childbearing potential, are unable or unwilling to use methods of contraception considered highly effective for the entire period of the study and for at least 90 days after the last dose of the investigational product, and who do not agree to avoid donating sperm\u002Feggs during this period.\n\n\\[Methods of contraception considered highly effective\\]\n\n* Intrauterine devices and intrauterine hormone-releasing systems with a proven contraception failure rate (\\\u003C 1%\u002Fyear) plus the use of a male condom\n* Bilateral tubal occlusion or bilateral tubal ligation plus the use of a male condom\n* Azoospermia is confirmed by sperm test after vasectomy\n* Hormonal contraception (e.g., combined oral contraceptive, progestogen-only oral contraceptive), contraceptive patch, vaginal ring, injection, subdermal contraceptive implant); however, hormonal contraception is limited to cases where it is being used for 28 days or longer prior to the administration of the investigational product and can be continuously used during the study period and up to 90 days after the last dose plus the use of a male condom.\n* Sexual abstinence, if it is the usual and preferred method of contraception.\n* Those judged by the principal investigator or delegate to be ineligible for participation in the study for reasons other than the above-mentioned criteria (non-compliance with instructions, etc.)",true,"65 Years",{"count":198,"type":20},74,[86],"This study aims to evaluate the safety, tolerability, pharmacokinetics, and food effect of a new investigational medicine called SCB0020160 in healthy adult men. This is the first time SCB0020160 will be administered to humans.\n\nHealthy adult men aged 18 to 65 years who meet the study eligibility criteria.\n\nStudy details\n\nParticipants will be randomly assigned to receive either SCB0020160 or placebo. The study includes single-dose and multiple-dose treatment periods, as well as an assessment of the effect of food on the absorption of SCB0020160.\n\nParticipants will undergo safety assessments including physical examinations, vital signs, ECGs, blood and urine tests, and monitoring of adverse events. The study will also assess how SCB0020160 is processed by the body.\n\nThere is no direct health benefit expected from participation. The results may help determine safe dose levels and support future clinical development of SCB0020160.",[27,202,203],"Obesity","Idiopathic Pulmonary Fibrosis","2026-06-26",{"date":116,"type":39},{"date":179,"type":20},{"date":208,"type":20},"2027-07-01",{"name":210,"class":99},"SCBIO Inc.",{"id":212,"slug":4,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":84,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100563701","NCT06619587","A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors","A Phase I\u002FII Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation","Inclusion Criteria:\n\n* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation\n* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm\n\nExclusion criteria:\n\n* Malabsorption or other condition that would interfere with enteral absorption\n* Active brain metastases\n* Clinically significant cardiovascular dysfunction or liver disease",{"count":218,"type":20},410,[86],"This is a first-in-human Phase I\u002FII, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.",[27],{"date":179,"type":39},{"date":224,"type":39},"2024-11-14",{"date":226,"type":20},"2028-05-31",{"name":228,"class":99},"Genentech, Inc.",41,{"id":231,"slug":4,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":84,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100494587","NCT05720117","A Study of PYX-201 in Advanced Solid Tumors","A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors","Inclusion\n\n1. Histologically or cytologically confirmed solid tumors including locally advanced\u002Fmetastatic HR+ and HER2- breast cancer (post CDK4\u002F6 inhibitor +\u002F- ET, ≤ 2 lines systemic therapy), TNBC (1-3 prior lines including post ADC topo-1 payload), HNSCC (1-2 prior lines including post PD-L1\u002FPD1 and platinum based therapy), and other solid tumor types (≤ 2 lines systemic therapy).\n2. Male or non-pregnant, non-lactating female participants age ≥18 years.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.\n4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n5. Life expectancy of \\>3 months, in the opinion of the Investigator.\n6. Corrected QTcF \\\u003C470 msec.\n7. Adequate hematologic function.\n8. Adequate hepatic function.\n9. Adequate renal function.\n10. Adequate coagulation profile.\n11. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.\n\nExclusion\n\n1. History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, noninvasive bladder cancer.\n2. Known symptomatic brain metastases.\n3. Significant cardiovascular disease within 6 months prior to start of study drug.\n4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.\n5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).\n6. Failure to recover to baseline severity or Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.\n7. Participants with NCI-CTCAE v5.0 Grade \\>1 neuropathy of any etiology.\n8. Prior solid organ or bone marrow progenitor cell transplantation.\n9. Prior high-dose chemotherapy requiring stem cell rescue.\n10. Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.\n11. Palliative radiation therapy within 14 days prior to the start of study drug.\n12. Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.\n13. History of uncontrolled diabetes mellitus.\n14. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.\n15. Participants with corneal epithelial disease, with the exception of mild punctate keratopathy\n16. Participants with the best-corrected visual acuity in the worst-seeing eye worse than 20\u002F100 (Snellen equivalent).\n17. Participants with a history of (noninfectious) pneumonitis\u002F interstitial lung disease that required steroids, has current pneumonitis\u002F interstitial lung disease, or evidence of active pneumonitis on screening chest CT scan or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.",{"count":237,"type":20},330,[86],"The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with recurrent\u002Fmetastatic (R\u002FM) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.",[27,241],"Advanced Solid Tumor",[243,244],"Recurrent\u002FMetastatic Solid Tumor","PYX-201",{"date":181,"type":39},{"date":247,"type":39},"2023-03-14",{"date":249,"type":20},"2028-06-30",{"name":251,"class":99},"Pyxis Oncology, Inc",29,{"id":254,"slug":4,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":84,"phases":262,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":47},"100462395","NCT05301101","High Dose Re-Irradiation Utilizing Advanced Deformable Image Registration (DIR) and Individualized Organ At Risk (OAR) Dose Calculations With Organ Specific Toxicity Analysis","High Dose Re-Irradiation Utilizing Advanced Deformable Image Registration (DIR) and Individualized Organ At Risk (OAR) Dose Calculations With Organ Specific Toxicity Analysis (REDIRICT)","REDIRICT","Inclusion Criteria:\n\n1. Provision of signed informed consent\n2. Patients ≥18 years of age receiving definitive or postoperative high dose radiation to volume that includes overlap with previously irradiated OAR(s).\n3. Prior radiation dosimetry must be available.\n4. Participants must have stage I-IV biopsy proven solid malignancy (histologic proof or unequivocal cytologic proof solid tumor malignancy from either the primary or any metastatic site). Documentation of pathology reports are required. Local review of pathology or cytology is at the discretion of the multidisciplinary team.\n5. Histologic confirmation of target lesion recurrence is recommended.\n6. Documentation of consensus for recommendation of reirradiation by multidisciplinary team and location of target lesion or postoperative site to be treated.\n7. Documentation of whether or not concurrent cancer therapy drugs are recommended and rationale.\n8. Documentation of rationale for not obtaining tissue confirmation of the target lesion, if applicable.\n9. Baseline target lesion imaging with CT, positron emission tomography (PET) \u002FCT, or MRI is required within six weeks of trial enrollment. CT or MRI simulation scans may be used for baseline imaging.\n10. Patients who have had disease resected in a previously irradiated field and are at high pathological and clinical risk for recurrence as defined by the treating Radiation Oncologist and multidisciplinary team, are eligible for study.\n11. Measurable disease is not required for patients being treated postoperatively.\n12. Baseline labs are per standard practice. Values will be dependent on the OARs being treated. (Per standard practice, radiation therapy volumes to OARs are modified to accommodate compromised renal, liver, pulmonary or other OAR function). Recommended labs and values include:\n\n    * Aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C 2.5 x upper limit of normal (ULN) or \\\u003C 5 x ULN with metastatic liver disease.\n    * Total bilirubin \\\u003C 1.5 x ULN\n    * Absolute neutrophil count (ANC) \\> 500 cells\u002Fmm\\^3\n    * Platelets \\> 50,000 cells\u002Fmm\\^3\n    * Creatinine \\\u003C 1.5 x ULN or Creatinine clearance \\> 45 mL\u002Fmin if creatinine is \\> 1.5 x ULN (calculated Creatinine Clearance (CrCl) based on Cockcroft-Gault equation)\n13. Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2.\n14. Patients must have resolution of acute toxic effect(s) of most recent cancer therapy to Grade 1 or 2.\n15. Life expectancy of at least 6 months.\n16. Female patients of childbearing potential must have negative urine or serum pregnancy test within 7 days prior to start of re-irradiation.\n17. Ability to complete the self-reported questionnaires (translations will be made available if the patient's primary language is not English).\n18. Concurrent participation on pharmaceutical, investigator-initiated, National Clinical Trials Network (NCTN), or other multisite clinical trials that include re-irradiation is allowed.\n\nExclusion Criteria:\n\n1. Patients receiving low dose radiation for symptom management only.\n2. Patients with evidence of severe or uncontrolled systemic conditions.\n3. Life expectancy of less than 6 months.\n4. ECOG Performance status ≥ 3.\n5. Women of childbearing potential who are known to be pregnant or are unwilling to use an acceptable method of contraception from the time of informed consent until completion of the course of radiotherapy",{"count":261,"type":20},120,[140],"This trial applies a uniform approach to re-irradiation for planning and diagnostic image fusion, dose summation, dose calculations, and follow up for tumor control and detailed toxicity analysis of serial Organs At Risk (OARs). Serial organs include named arteries and nerves, spinal cord, and gastrointestinal tract.",[27],[266,267],"high dose radiation","re-irradiation",{"date":181,"type":39},{"date":270,"type":39},"2022-06-13",{"date":272,"type":20},"2028-07",{"name":274,"class":74},"Medical College of Wisconsin",{"id":276,"slug":4,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":84,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":291,"leadSponsor":293,"locationsCount":47},"100645170","NCT07678970","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to follow the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic digestive tract tumors and other solid tumors;\n6. Agree to provide archived tumor tissue specimens within 2 years from the primary or metastatic lesion, or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n9. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n11. Organ function levels must meet the protocol requirements;\n12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN);\n13. Urine protein ≤2+ or ≤1000 mg\u002F24 h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and they must not be breastfeeding; all enrolled patients (regardless of male or female) should use adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion;\n15. Trial participants are capable of and willing to comply with the visit schedules, treatment plans, laboratory tests, and other study-related procedures as stipulated in the study protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose;\n2. Receipt of immunosuppressive medications within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Prior history of ≥ Grade 3 toxicity related to anti-angiogenic therapy during previous anti-angiogenic treatment;\n7. Diagnosis of another solid tumor within 5 years prior to the first dose;\n8. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n9. Uncontrolled hypertension;\n10. Diabetic patients with poorly controlled blood glucose;\n11. History of interstitial lung disease (ILD) requiring steroid therapy, or current ILD, or ≥ Grade 2 radiation pneumonitis;\n12. Concurrent pulmonary disease resulting in severe impairment of respiratory function;\n13. Patients with active central nervous system (CNS) metastases;\n14. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of SI-B036;\n15. Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation;\n16. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;\n18. Presence of pleural, abdominal, or pelvic effusion or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n19. Imaging findings indicating that the tumor has invaded or encased the major thoracic blood vessels;\n20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or lactating women;\n24. Other conditions deemed by the investigator to make the subject unsuitable for participation in this clinical trial.","75 Years",{"count":283,"type":20},16,[86],"This study is an open-label, multicenter, non-randomized Phase I clinical study with dose-escalation and expansion cohorts, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.",[287,27],"Gastrointestinal Tumor","2026-06-25",{"date":114,"type":39},{"date":94,"type":20},{"date":292,"type":20},"2028-12",{"name":294,"class":99},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":296,"slug":4,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":281,"enrollmentInfo":301,"targetDuration":4,"studyType":84,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":310,"locationsCount":47},"100637532","NCT07606612","A Study of SI-B036 in Patients With Locally Advanced or Metastatic Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SI-B036 Bispecific Antibody Injection in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Locally advanced or metastatic solid tumors;\n6. Agree to provide archived tumor tissue specimens from primary or metastatic lesions within 2 years or fresh tissue samples;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. ECOG performance status score of 0 or 1;\n9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the requirements;\n12. Coagulation function: International Normalized Ratio ≤1.5, and Activated Partial Thromboplastin Time ≤1.5 × ULN;\n13. Urine protein ≤2+ or ≤1000 mg\u002F24h;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must adopt adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion;\n15. The trial participant is capable and willing to adhere to the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose;\n2. Receipt of immunosuppressive therapy within 2 weeks prior to the first dose;\n3. History of severe cardiac or cerebrovascular disease;\n4. QT interval prolongation, complete left bundle branch block, etc.;\n5. Active autoimmune diseases and inflammatory diseases;\n6. Prior experience of ≥ grade 3 toxicity related to anti-angiogenic therapy during previous anti-angiogenic treatment;\n7. Diagnosis of another solid tumor within 5 years prior to the first dose;\n8. Unstable thrombotic event requiring therapeutic intervention within 6 months prior to the first dose;\n9. Poorly controlled hypertension;\n10. Diabetic patients with poorly controlled blood glucose;\n11. History of ILD requiring steroid therapy, or current ILD, or ≥ grade 2 radiation pneumonitis;\n12. Concomitant pulmonary disease causing severe respiratory impairment;\n13. Active central nervous system metastases;\n14. History of allergy to recombinant humanized or human-mouse chimeric antibodies, or hypersensitivity to any excipient component of SI-B036;\n15. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n16. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first dose of study drug;\n18. Presence of pleural, abdominal, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first dose of study drug;\n19. Imaging findings indicating tumor invasion or encasement of major thoracic blood vessels, pericardium, or heart;\n20. Study participants with clinically significant bleeding or a clear bleeding tendency within 4 weeks prior to screening;\n21. History of fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first dose;\n22. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n23. Pregnant or breastfeeding women;\n24. Other conditions deemed by the investigator to make the participant unsuitable for enrollment in this clinical trial.",{"count":302,"type":20},31,[86],"This study is an open-label, multicenter, non-randomized Phase I clinical study of dose-escalation and expansion to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SI-B036 bispecific antibody injection in patients with locally advanced or metastatic solid tumors.",[27],{"date":204,"type":39},{"date":308,"type":39},"2026-06-11",{"date":292,"type":20},{"name":294,"class":99},{"id":312,"slug":4,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":281,"enrollmentInfo":317,"targetDuration":4,"studyType":84,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":47},"100603736","NCT07140393","A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor","An Open, Multicenter Phase IB\u002FII Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor","Inclusion Criteria:\n\n1. Age: 18 to 75 years old; Both men and women are welcome;\n2. The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .\n3. ECOG ratings of 0 or 1.\n4. Expected survival period ≥ 12 weeks.\n5. At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.\n6. Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.\n\nExclusion Criteria:\n\n1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis\n2. There have been significant severe infections and major surgeries in the past 4 weeks\n3. Existence of previous or concurrent malignant tumors\n4. Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication\n5. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration;",{"count":261,"type":20},[86,87],"The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS-4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)\u002Fserious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.",[27],{"date":179,"type":39},{"date":323,"type":39},"2025-10-28",{"date":325,"type":20},"2028-10",{"name":327,"class":99},"Jiangsu HengRui Medicine Co., Ltd.",{"id":329,"slug":4,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":281,"enrollmentInfo":334,"targetDuration":4,"studyType":84,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":342,"leadSponsor":343,"locationsCount":47},"100644896","NCT07676903","A Clinical Study of SHR-4685 on Safety, Tolerability and Pharmacokinetics in Participants With Solid Tumors","A Phase I Clinical Study of SHR-4685 on Safety, Tolerability and Pharmacokinetics in Participants With Solid Tumors","Inclusion Criteria:\n\n1. Have fully understood this study and voluntarily signed the informed consent form, with good compliance and cooperation with follow-up;\n2. Age 18-75 years, any gender;\n3. Performance status ECOG score 0 or 1;\n4. Expected survival time greater than 3 months;\n5. Presence of at least one measurable lesion according to RECIST 1.1 criteria;\n6. Have adequate organ function;\n7. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose; and must not be lactating.\n\nExclusion Criteria:\n\n1. Participants who have received any approved anti-tumor drugs (including investigational anti-tumor drugs) within 4 weeks prior to the first dose of the IP;\n2. Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 or to the level specified in the inclusion\u002Fexclusion criteria;\n3. Presence of central nervous system (CNS) metastases;\n4. Concurrent active malignancy other than the primary tumor;\n5. History of central nervous system diseases within 12 months prior to screening;\n6. Participants who have undergone major surgery other than diagnostic or biopsy procedures within 28 days prior to the first dose, or who are expected to undergo major surgery during the study;\n7. Participants with active tuberculosis or a history of active tuberculosis infection within ≤48 weeks prior to screening, regardless of treatment;\n8. Presence of any significant clinical or laboratory abnormality that, in the investigator's opinion, affects safety evaluation;\n9. History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening;\n10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention;\n11. Positive for human immunodeficiency virus (HIV) (HIV1\u002F2 antibodies) with CD4+ T lymphocyte count \\\u003C350 cells\u002FuL; or history of other acquired\u002Fcongenital immunodeficiency diseases; or history of allogeneic bone marrow or solid organ transplantation;\n12. Active chronic hepatitis B or active hepatitis C;\n13. Known history of hypersensitivity to any component of the formulations used in the study;\n14. Other factors, in the opinion of the investigator, that may affect the study results or result in forced halfway termination of this study, such as alcoholism, drug abuse, suffering from other serious diseases (including psychiatric disorders) requiring concomitant treatment, seriously abnormal laboratory test values, family or social factors and other conditions that may affect the safety of the patient or collection of study data.",{"count":335,"type":20},170,[86],"The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of SHR-4685 in participants with advanced solid tumors.",[27],"2026-06-24",{"date":181,"type":39},{"date":94,"type":20},{"date":325,"type":20},{"name":344,"class":99},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",{"id":346,"slug":4,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":195,"sex":15,"minAge":351,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":354,"conditions":355,"keywords":360,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":372},"100342530","NCT03739827","Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors","Natural History and Biospecimen Acquisition Study for Children and Adults With Rare Solid Tumors","* INCLUSION CRITERIA:\n* Cohort 1: Participants with a diagnosis of a rare solid tumor (fewer than 15 cases in 100,000 people per year). There are no age restrictions beyond the neonatal period (4 weeks).\n\nOR\n\n-Cohort 2: Participants without a rare tumor who have a germline genetic variant that predisposes to a rare solid tumor\n\nOR\n\n-Cohort 3: Relatives of participants with diagnosis of rare solid tumors who do NOT have a known germline variant that predisposes to a rare solid tumor\n\nOR\n\n* Cohort 4: Parent\u002Fguardian of child participating in a focus group if not already enrolled on the study.\n* Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nNone","4 Weeks",{"count":353,"type":20},10000,"Background:\n\nApproximately 150 cases of cancer per one million per year are considered rare cancers. While all tumors originate from genetic changes, a small percentage of these tumors are familial. Researchers want to study these changes in biological samples from people with rare tumors in order to learn more about how these tumors develop. The information obtained from this study may lead to improved screening, preventive guidelines, and treatments.\n\nObjective:\n\nTo better understand rare cancers and hereditary cancer syndromes.\n\nEligibility:\n\nPeople who have a rare tumor, a family history of a rare tumor, a hereditary cancer syndrome, or a mutation that leads to rare tumors.\n\nDesign:\n\nParticipants will be screened with questions about their medical history and\u002For that of their family members. They will give a saliva sample.\n\nParticipants who have a tumor will have their medical records and tests reviewed. They will answer questions about their wellbeing and needs. They may provide a tumor tissue sample.\n\nParticipants may also have:\n\n* Physical exam\n* Clinical photography\n* Blood, urine, saliva, and stool samples taken\n* Consultation with specialists\n* A scan that produces a picture of the body. Either one that uses a small amount of radiation, or one that uses a magnetic field.\n* Genetic testing\u002Fgenetic counseling.\n\nParticipants will be contacted once a year. They will answer updated questions about their medical and family history.\n\nParticipants will be asked to contact the study team if there are changes in their tumors.\n\nParticipants may be invited to join focus groups for people with the same diagnosis of rare tumors.\n\nParticipants may be invited to participate in other NIH protocols.\n\n\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\n\n\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\n\nRARE TUMOR LIST:\n\n1. Acinar cell carcinoma of the pancreas\n2. Adamantinoma\n3. Adenosqaumous carcinoma of the pancreas\n4. Adrenocortical carcinoma\n5. Alveolar soft part sarcoma\n6. Anaplastic Thyroid Cancer\n7. Angiosarcoma\n8. Atypical Teratoid Rhabdoid Tumor\u002FMRT\n9. Carcinoid\n10. Carcinoma of Unknown Primary\n11. Chondrosarcoma\n12. Chondromyxoid fibroma\n13. Chordoma\n14. Clear cell renal carcinoma\n15. Clear Cell Sarcoma\n16. Clear cell sarcoma of kidney\n17. Conventional chordoma\n18. Dedifferentiated chordoma\n19. Desmoid\n20. Desmoplastic small round cell tumor\n21. Epithelioid hemangioendothelioma\n22. Esthenioneuroblastoma\n23. Ewing Sarcoma\n24. Fibrolamellar carcinoma\n25. Fusion negative rhabdomyosarcoma\n26. Fusion positive renal cell carcinoma\n27. Fusion positive rhabdomyosarcoma\n28. Gastro-enteropancreatic neuroendocrine tumor\n29. Hepatoblastoma\n30. Hereditary Diffuse Gastric Cancer\n31. Inflammatory myofibroblastic tumor\n32. Kaposiform hemangioendothelioma\n33. Malignant ectomesenchymal tumor\n34. Malignant peripheral nerve sheath tumor\n35. Malignant triton tumor\n36. Medullary thyroid cancer\n37. Mixed acinar adenocarcinoma\n38. Mixed acinar neuroendocrine carcinoma\n39. Myxoid Liposarcoma\n40. Neuroblastoma\n41. Neuroendocrine tumors\n42. NUT midline carcinoma\n43. Osteosarcoma\n44. Pancreas ductal adenocarcinoma with squamous features\n45. Pancreatic acinar cell carcinoma\n46. Papillary renal cell carcinoma\n47. Paraganglioma\n48. Parosteal Osteosarcoma\n49. Periosteal Osteosarcoma\n50. Peripheral nerve sheath tumor\n51. Peripheral primitive neuroectodermal tumor\n52. Pheochromocytoma\n53. Pituitary cancer\n54. Poorly differentiated chordoma\n55. Renal medullary carcinoma\n56. Rhabdomyosarcoma\n57. Round cell Liposarcoma\n58. Schwannoma\n59. Sclerosing Epithelioid Fibrosarcoma\n60. SDH deficient GIST\n61. SMARCB1 deficient tumors\n62. SMARCA4 deficient tumors\n63. Synovial sarcoma\n64. Undifferentiated Sarcoma\n\n    \\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\n\n    \\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*",[356,357,358,359,27],"Malignant Solid Tumors","Other Neoplasms Solid Tumors","Pediatric Solid Tumor","Refractory Solid Tumors",[361,362,363,364],"Service to the Patients","Knowledge about the Nature of Cancer","Cancer Evaluations","Natural History","2026-06-23",{"date":339,"type":39},{"date":368,"type":39},"2019-01-28",{"date":370,"type":20},"2032-03-31",{"name":45,"class":46},3,{"id":374,"slug":4,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":379,"enrollmentInfo":380,"targetDuration":4,"studyType":84,"phases":382,"briefSummary":384,"conditions":385,"keywords":390,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":302},"100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.","100 Years",{"count":381,"type":20},100,[383],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[386,387,27,388,389],"Melanoma","Non Small Cell Lung Cancer","Rare Cancers","High Grade Glioma",[391,392,393,394,395,386,396,397,398,399,400,387,401,402,403,404,389],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","Lung Cancer","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers","2026-06-22",{"date":365,"type":39},{"date":408,"type":39},"2017-12-28",{"date":410,"type":20},"2032-12-28",{"name":412,"class":99},"Novartis Pharmaceuticals",{"id":414,"slug":4,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":84,"phases":421,"briefSummary":422,"conditions":423,"keywords":426,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":441},"100589253","NCT06952010","A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors","A Phase 1 Dose Escalation and Expansion Study of XB628 as a Single Agent and in Combination With Zanzalintinib in Participants With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Minimum life expectancy of ≥ 12 weeks.\n* Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed.\n* Adequate organ and marrow function.\n* Not amenable to curative treatment with surgery or radiation.\n* Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting.\n* Acceptable alternative therapy was received, refused, intolerable, or no longer effective.\n* Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements.\n\nKey Exclusion Criteria\n\n* Primary brain tumors or known active brain metastases.\n* Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment.\n* Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy.\n* Received prior therapy targeting NK cells (eg, monalizumab).\n* A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":420,"type":20},303,[86],"This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and\u002For recommended dosage(s) for expansion (RDE\\[s\\]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.",[27,241,424,425],"Metastatic Solid Tumor","Immune Sensitive Tumor",[427,403,428,429,430,431,432],"XB628","Advanced solid tumor","Metastatic solid tumor","Immune sensitive tumor","PD-L1","Zanzalintinib","2026-06-19",{"date":339,"type":39},{"date":436,"type":39},"2025-05-01",{"date":438,"type":20},"2027-11-30",{"name":440,"class":99},"Exelixis",11,{"id":443,"slug":4,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":84,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":460},"100484179","NCT05584670","A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors","A Phase 1\u002F2, Open Label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Dose escalation Part 1A and Japan Cohort F\n\n   * Participants with advanced unresectable or metastatic solid tumors for which, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant\n2. Dose escalation Part 1B\n\n   * Participants with advanced unresectable or metastatic melanoma, NSCLC; renal cell carcinoma (RCC); HCC, colorectal cancer (MSI-H\u002FdMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC). and for who, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant.\n3. Dose escalation Part 1C\n\n   * Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer\n   * Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.\n4. Dose expansion\u002Foptimization Part 2\n\n   Cancer diagnosis:\n   * Participants in Cohorts A1 and A2 (Part 2A): Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)\n   * Participants in Cohort B (part 2A): Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants (participants without cirrhosis must have had histological confirmation of diagnosis)\n   * Participants in Cohorts C1 and C2 (part 2A):\n\n     * Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic gastric cancer (GC) or Siewert Type 2 \\& 3 gastro esophageal junction (GEJ) adenocarcinoma\n     * Disease with any CPS scoring. No need for CPS determination at local laboratory\n     * Participants must have MSI (metastatic microsatellite instability) or MMR (mismatch repair) status known or determined locally and must have non-MSI-H or proficient MMR (pMMR) disease to be eligible.\n     * Participants with unknown HER2\u002Fneu status must have their HER2\u002Fneu status determined locally. Participants with HER2\u002Fneu negative are eligible. Participants with HER2\u002Fneu positive tumors must have documentation of disease progression on treatment containing an approved HER2 targeted therapy to be eligible.\n   * Participants in Part 2A Cohorts E1 and E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer.\n   * Participants in Part 2A Cohorts E1, and E2 and Part 2B Cohort E3 MSI status:\n\n   Participants must have MSI status known or determined locally and must have non- MSI-H disease to be eligible.\n   * Participants in Part 2A Cohorts E1, E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.\n   * Part 2C Cohorts G1, G2 and G3: Participants with histologically confirmed unresectable locally advanced or metastatic melanoma\n5. Prior anticancer therapy (For dose expansion\u002Foptimization Part 2 only)\n\n   * Participants in Cohorts A1 and A2: Participants must have received at least 1 systemic therapy for the metastatic setting and must not be amenable to the available SOC.\n   * Participants in Cohort B: Participants who have received at least 1 prior anticancer therapy, including an anti-PD1\u002FPD-L1 containing regimen, and for whom have progressed after a primary or secondary resistance to an anti-PD1\u002FPD-L1.\n   * Participants in Cohorts C1 and C2: Participants should have failed or relapsed after at least 1 prior line of treatment which may or may not include an anti-PD1\u002FPD-L1-based treatment depending on local standard of care.\n   * Participants in Cohort D: Participants must have received at least 1 systemic therapy for their advanced\u002F metastatic setting and must not be amenable to the available SOC.\n   * Participants in Part 2A Cohorts E1 and E2 and Part 2D Cohorts H1 and H2 should have failed or relapsed on at least 2 prior regimens.\n   * Participants in cohort E3 should have failed or relapsed on at least 1 prior regimen. Participants who have received cetuximab or other anti-EGFR therapy as part of their prior line of treatment are eligible.\n   * Part 2C Cohorts G1, G2 and G3: Participants must have received at least one prior line of therapy for advanced\u002Fmetastatic melanoma and\u002For does not have any standard of care (SoC) treatment option or decline or is intolerant to be treated with SoC treatment.\n\nMeasurable Disease:\n\n* At least 1 measurable lesion per RECIST 1.1 criteria\n\nPart 1C and Part 2D: Adequate coagulation function for all participants. For participants receiving anti-coagulant therapy (except platelet anti-aggregates) the adequate therapeutic levels of INR should be confirmed.\n\nCapable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≥2\n* Predicted life expectancy ≤3 months\n* For participants with HCC- Cohort B (Part 2): Child Pugh Class B or C liver score. Participants with Child Pugh Class B-7 score are allowed for Part 1.\n* Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment\n* Known active brain metastases or leptomeningeal metastases\n* History of treatment-related immune-mediated (or immune-related) AEs from immune-modulatory agents (including but not limited to anti-PD1\u002FPD-L1 agents and anti-cytotoxic T lymphocyte associated protein 4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were Grade 4 in severity or have not resolved to Grade ≤1\n* Has any condition requiring ongoing\u002Fcontinuous corticosteroid therapy (\\>10 mg prednisone\u002Fday or an anti-inflammatory equivalent) within 1 week prior to the first dose of the study medicine\n* Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration\n* Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events\n* Has a known history or any evidence of interstitial lung disease or active, non-infectious pneumonitis within 3 years prior to the first dose of the study drug.\n* Organ transplant requiring immunosuppressive treatment\n* Uncontrolled or active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or has a diagnosis of immunodeficiency\n\nNOTE: Other Inclusion\u002FExclusion criteria may apply.\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.",{"count":449,"type":20},542,[86,87],"This is a Phase 1\u002F2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors.\n\nThe study will include 2 parts:\n\nA dose escalation Part 1: for finding the therapeutic dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW) and in combination with other anticancer therapies when applicable.\n\nA multicohort dose expansion\u002Fdose optimization Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab or with next generation aCTLA4 (ADG126) or with bevacizumab. 2 recommended doses for expansion\u002Foptimization of SAR445877 identified from dose escalation part 1 will be tested in different indications in monotherapy and in combination with other anticancer therapies as applicable.\n\nApproximately 542 participants will be exposed to the study intervention:\n\n* approximately 123 participants in part 1,\n* up to 410 participants in expansion\u002Fdose optimization part (part 2)\n* and up to 9 participants in Japan cohort F.",[27],{"date":365,"type":39},{"date":455,"type":39},"2022-11-29",{"date":457,"type":20},"2028-06-28",{"name":459,"class":99},"Sanofi",22,{"id":462,"slug":4,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":15,"minAge":467,"maxAge":281,"enrollmentInfo":468,"targetDuration":4,"studyType":84,"phases":469,"briefSummary":470,"conditions":471,"keywords":472,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":47},"100472855","NCT05437315","GD2\u002FPSMA Bi-specific CAR-T Cell Therapy","GD2\u002FPSMA Bi-specific CAR-T Cells For the Treatment of GD2 and PSMA Positive Solid Tumors","Inclusion Criteria:\n\n1. Patients with tumors have received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.\n2. The expression status of GD2 or PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses.\n3. Body weight greater than or equal to 10 kg.\n4. Age: ≥1 year and ≤ 75 years of age at the time of enrollment.\n5. Life expectancy: at least 8 weeks.\n6. Prior Therapy:\n\n   There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must be resolved to grade 2 or less.\n7. Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection.\n8. At least 7 days must have elapsed since the completion of therapy with a biologic agent, selected targeted agent or a metronomic non-myelosuppressive regimen.\n9. At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody.\n10. At least 1 week since any radiation therapy at the time of study entry.\n11. Karnofsky\u002Fjansky score of 60% or greater.\n12. Cardiac function: Left ventricular ejection fraction greater than or equal to 40\u002F55 percent.\n13. Pulse Ox greater than or equal to 90% on room air.\n14. Liver function: defined as alanine transaminase (ALT) \\\u003C3x upper limit of normal (ULN), aspartate aminotransferase (AST) \\\u003C3x ULN; serum bilirubin and alkaline phosphatase \\\u003C2x ULN.\n15. Renal function: Patients must have serum creatinine less than 3 times upper limit of normal.\n16. Marrow function: White blood cell count ≥1000\u002Ful, Absolute neutrophil count ≥500\u002Ful, Absolute lymphocyte count ≥500\u002Ful, Platelet count ≥25,000\u002Ful (not achieved by transfusion).\n17. Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease does not have hematologic toxicity.\n18. For all patients enrolled in this study, themselves or their parents or legal guardians must sign an informed consent and assent.\n\nExclusion Criteria:\n\n1. Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or greater than grade 2 hematologic toxicity.\n2. Untreatable central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible.\n3. Previous treatment with other genetically engineered GD2 or PSMA-specific CAR T cells or antibody therapy.\n4. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.\n5. Patients who require systemic corticosteroid or other immunosuppressive therapy.\n6. Evidence of tumor potentially causing airway obstruction.\n7. Inability to comply with protocol requirements.\n8. Insufficient CAR T cells availability.","1 Year",{"count":107,"type":20},[86,87],"The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2\u002FPSMA bi-specific CAR-T cell therapy in patients with GD2 and PSMA positive tumor. Another goal of the study is to learn more about the function of the anti-GD2\u002FPSMA bi-specific CAR-T cells and their persistency in patients.",[27],[473,403,474,475],"CAR-T","GD2","PSMA","2026-06-18",{"date":365,"type":39},{"date":479,"type":39},"2026-06-01",{"date":481,"type":20},"2030-12-31",{"name":483,"class":74},"Shenzhen Geno-Immune Medical Institute",{"id":485,"slug":4,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":15,"minAge":467,"maxAge":281,"enrollmentInfo":490,"targetDuration":4,"studyType":84,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":496,"leadSponsor":497,"locationsCount":47},"100395711","NCT04432649","Targeting CD276 (B7-H3) Positive Solid Tumors by 4SCAR-276","Multicenter Trial of Phase I\u002FII Studies on CD276 (B7-H3) Positive Solid Tumors Treated With 4SCAR-276","Inclusion Criteria:\n\n* Patients with tumors have received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.\n* The CD276 antigen status of the tumor is determined for eligibility. Positive expression is defined by antibody staining results based on immunohistochemistry or flow cytometry analysis.\n* Body weight greater than or equal to 10 kg.\n* Age: ≥1 year and ≤ 75 years of age at the time of enrollment.\n* Life expectancy: at least 8 weeks.\n* Prior Therapy: 1) There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less. 2) Must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection. 3) At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic nonmyelosuppressive regimen. 4) At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody. 5) At least 1 week since any radiation therapy at the time of study entry.\n* Karnofsky\u002Fjansky score of 60% or greater.\n* Cardiac function: Left ventricular ejection fraction greater than or equal to 40\u002F55 percent .\n* Pulse Ox greater than or equal to 90% on room air.\n* Liver function: defined as alanine transaminase (ALT) \\\u003C3x upper limit of normal (ULN), aspartate aminotransferase (AST) \\\u003C3x ULN; serum bilirubin and alkaline phosphatase \\\u003C2x ULN.\n* Renal function: Patients must have serum creatinine less than 3 times upper limit of normal.\n* Marrow function: White blood cell count ≥1000\u002Ful, Absolute neutrophil count ≥500\u002Ful, Absolute lymphocyte count ≥500\u002Ful, Platelet count ≥25,000\u002Ful (not achieved by transfusion).\n* Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease not evaluable to have hematologic toxicity.\n* For all patients enrolled in this study, themselves or their parents or legal guardians must sign an informed consent and assent.\n\nExclusion Criteria:\n\nExisting severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or grade 3 hematologic toxicity.\n\n* Untreated central nervous system (CNS) metastasis: Patients with CNS tumor involvement that has been treated and\u002For is stable for at least 6 weeks following completion of therapy are eligible.\n* Previous treatment with other genetically engineered CD276-CAR T cells or CD276 antibody therapy.\n* Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.\n* Patients who require systemic corticosteroid or other immunosuppressive therapy.\n* Evidence of tumor potentially causing airway obstruction.\n* Inability to comply with protocol requirements.\n* Insufficient CAR T cells availability.",{"count":381,"type":20},[86,87],"Patients with refractory and\u002For recurrent solid tumor have poor prognosis despite complex multimodel therapy and therefore, novel approaches are urgently needed. This study attempts to treat these diseases using T cells genetically modified with a 4th generation lentiviral chimeric antigen receptor (4SCAR fused with an inducible apoptotic caspase 9 domain) targeting CD276 (B7-H3). The 4SCAR-CD276-modified T cells (4SCAR-276) can recognize and kill tumor cells through the recognition of CD276, a surface protein expressed at high levels on many types of tumors but at low levels on normal tissues. This study will evaluate the side effects and effective doses of 4SCAR-276 in treating refractory and\u002For recurrent tumors.",[27],{"date":365,"type":39},{"date":479,"type":39},{"date":481,"type":20},{"name":483,"class":74},{"id":499,"slug":4,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":11,"sex":15,"minAge":505,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":519},"100479659","NCT05525858","KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II","KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II","KOSMOSII","Inclusion Criteria:\n\n* 19 years of age or older\n* Histologically proven locally advanced or metastatic solid tumors\\*\\*\\* who showed disease progression on standard first line anti-cancer treatment and\u002For has no standard treatment option\n\n  \\*\\*\\* very rare diseases without standard treatment option which form solid mass, such as Erdheim Chester disease can be enrolled after KOSMOS MTB approval\n* A genomic test results must be available in a MFDS-accredited for laboratories offering service, or in part of clinical trial\u002Fstudy or other commercial labs approved and certified by regulatory bodies compatible with MFDS, such as CLIA. A genomic test can be conducted with tumor tissue as well as plasma circulating tumor DNA.\n\n  1. Results from genomic profiling tests performed after diagnosis with metastatic\u002Fadvanced disease to registration are acceptable. NGS results performed within three years prior to registration are preferred. Those patients with NGS results from primary tumor or more than 3 years prior to enrollment can be registered and whether NGS data is acceptable will be subject to MTB decision.\n  2. NGS panels should be i. Tested in a lab that is accredited by one or more quality assurance program (e.g., Korean Institute of Genomic Testing Evaluation, The Korean Society of Pathologists, Korean Society for Laboratory Medicine, Korea Laboratory Accreditation Scheme, etc.) ii. Patients who have insufficient genomic information from their NGS results (e.g., lack of variant calling format file or uninterpretable reports) or who are candidates of immunotherapy will submit their tissue and\u002For blood, for central NGS testing and exploratory biomarker analysis.\n* Ability to understand and the willingness to sign a written informed consent document\n* Life expectancy of at least 12 weeks\n* Adequate recovery from most recent systemic or local treatment for cancer.\n\nExclusion Criteria:\n\n* Patients receiving any anti-cancer treatment (local treatment, chemotherapy, immunotherapy, targeted therapy) within 2 weeks prior to the start of study treatment\n* Any clinical condition, according to the opinion of site physicians, which makes molecular profiling guided therapy not at the best interest of the participating patient.\n* Patients who have ongoing toxicities of ≥ CTCAE 2, other than peripheral neuropathy, related to previous anti-cancer treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE 3 will be excluded. Laboratory abnormalities ≥ CTCAE 2 considered as not clinically significant by the study physician will be allowed.\n* Pregnant or breastfeeding, or intending to become pregnant during the study","19 Years",{"count":507,"type":20},1000,"A national, prospective, multi-center, open-label, multi-cohort study comprised of a framework to screen patients for actionable targets and evaluation of molecular profiling guided therapy recommended by MTB based on genomic alterations using targeted and\u002For immunotherapies outside of the approved indications via local clinical practice (Tier 1 \\& 2) and clinical trials (Tier 3)",[27,241,510],"Metastatic Cancer","2026-06-17",{"date":405,"type":39},{"date":514,"type":39},"2022-09-28",{"date":516,"type":20},"2027-03",{"name":518,"class":74},"Seoul National University Bundang Hospital",32,{"id":521,"slug":4,"hasResults":11,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":84,"phases":529,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":547},"100452820","NCT05176483","Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors","A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors","STELLAR-002","Key Inclusion Criteria:\n\n* Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.\n* Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n* Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.\n\n  * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.\n* Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.\n\n  * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)\u002FProgrammed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.\n  * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.\n* Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.\n\n  * Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.\n* Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).\n\n  * Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence \\\u003C 12 months from the end of last therapy.\n  * Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.\n* Expansion Cohort 5 (post enfortumab vedotin \\[EV\\] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.\n\n  * Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1\u002FPD-L1 inhibitor or ineligible for PD-1\u002FPD-L1 inhibitor.\n  * Prior receipt of platinum-based therapy allowed but not required.\n  * Prior therapy with other agents allowed but not required.\n* Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.\n\n  * No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.\n* Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and\u002For unresectable HCC that is not amenable to curative treatment or locoregional therapy.\n* Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score \\[TPS\\] 1-49%) and without prior systemic anticancer therapy for metastatic disease.\n* Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.\n* Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.\n* Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.\n* Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.\n\n  * Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma\n* Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.\n* For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.\n* For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.\n* Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and\u002For stable on supportive therapy.\n* Karnofsky Performance Status (KPS) ≥ 70%.\n* Adequate organ and marrow function.\n* Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.\n* Females of childbearing potential must not be pregnant at screening.\n\nKey Exclusion Criteria:\n\n* For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1\u002FPD-L1, Lymphocyte-activation gene 3 (LAG-3) and cCytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n* Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.\n* Administration of a live, attenuated vaccine within 30 days prior to first dose.\n* Uncontrolled, significant intercurrent or recent illness.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 460 ms for females and \\> 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.\n* Participants with inadequately treated adrenal insufficiency.\n* Pregnant or lactating females.\n* Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.\n* For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.\n* For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.\n* For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.\n* For Cohort 7 (HCC):\n\n  * Documented hepatic encephalopathy (HE) within 6 months before the first dose.\n  * Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.\n  * Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.\n  * Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma\n* For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and\u002For trifluridine + tipiracil (TAS-102).\n* For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.\n* For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable \\[MSS\\], 2L+), and 11 (HNSCC):\n\n  * Troponin T (TnT) or I (TnI) \\> 2 × institutional upper limit of normal (ULN).\n\nNote: Additional Inclusion and Exclusion criteria may apply.",{"count":528,"type":20},1314,[86],"This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.\n\nIn the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.",[532,533,534,27,535,536,537,538,539,540],"Renal Cell Carcinoma (RCC)","Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Urothelial Carcinoma (UC)","Hepatocellular Carcinoma (HCC)","Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)",{"date":405,"type":39},{"date":543,"type":39},"2021-12-14",{"date":545,"type":20},"2030-06-28",{"name":440,"class":99},122,{"id":549,"slug":4,"hasResults":11,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":554,"enrollmentInfo":555,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":556,"conditions":557,"keywords":560,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":571},"100560616","NCT06579469","Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy","Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)","Inclusion Criteria:\n\n* Participants must have received an initial systemically-administered CAR T cell infusion within the last 1-3 months (+\u002F- 14 days).\n\n  * Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT.\n* Age ≤ 30 years at CAR T cell infusion.\n\nExclusion Criteria:\n\n* Active malignancy other than the disease under study.\n* Planned consolidative HSCT within 3 months post CAR T cell infusion.\n* Received or planned additional disease directed therapy post CAR T cell infusion.\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.","30 Years",{"count":381,"type":20},"This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and\u002For have damage to the nervous system.",[558,559,27],"B-ALL","Hematologic Malignancy",[561,562],"CAR T cell infusion","Late Effects","2026-06-16",{"date":476,"type":39},{"date":566,"type":39},"2026-01-20",{"date":568,"type":20},"2029-03",{"name":570,"class":74},"St. Jude Children's Research Hospital",6,{"id":573,"slug":4,"hasResults":11,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":84,"phases":580,"briefSummary":581,"conditions":582,"keywords":610,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":637},"100499720","NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.",{"count":579,"type":20},554,[86,87],"BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.",[583,584,585,402,586,401,587,588,589,590,591,592,176,27,593,175,594,595,596,597,598,599,600,601,602,603,604,605,606,607,608,609],"Non-small Cell Lung Cancer","Histiocytic Neoplasm","Histiocytosis","BRAF V600E","BRAF Mutation-Related Tumors","BRAF","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Lung Cancer","Recurrent Lung Cancer","Recurrent Lung Non-Small Cell Carcinoma","Solid Carcinoma","KRAS G12V","KRAS Mutation-Related Tumors","NRAS Gene Mutation","Thyroid Cancer","Thyroid Carcinoma","Colorectal Cancer","Colorectal Carcinoma","Recurrent Histiocytic and Dendritic Cell Neoplasm","Brain Metastases","Recurrent NSCLC","KRAS G13C","Acquired Resistance to KRAS G12C Inhibitor","KRAS G12A","KRAS G12F","KRAS G12R","KRAS G13D",[611,612,613,614,615,616,617,618,619,620,621,622,623,624,625,626,627,628,629],"BRAF Class I","BRAF Class II","BRAF Class III","KRAS","Intolerant histiocytic neoplasm","BDTX-4933","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions",{"date":511,"type":39},{"date":632,"type":39},"2023-04-18",{"date":634,"type":20},"2028-06",{"name":636,"class":74},"Institut de Recherches Internationales Servier",27,""]