[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumors":653},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,119,0,25,[9,49,62,91,115,147,174,205,231,255,280,307,329,361,383,404,427,452,486,514,543,563,582,613,632],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053826",false,"NCT07509034","Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease","A Phase I Study to Assess the Safety and Antitumor Activity of Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease","* INCLUSION CRITERIA:\n* Age \\>=18 years old.\n* Histologically confirmed small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancers (EP-NEC) that has recurred following or is refractory to first-line therapy. Note: small cell cancers of non-lung primary sites are also eligible.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.\n* Pulse oximetry \\>= 90 percent on room air.\n* Aspartate Transferase (AST) \\\u003C 3 X institutional upper limit of normal (ULN). Note: in case of liver metastases 5 X ULN is acceptable.\n* Alanine Aminotransferase (ALT) \\\u003C 3 X institutional ULN. Note: in case of liver metastases \\\u003C= 5 X ULN is acceptable.\n* Total bilirubin \\\u003C=2 X institutional ULN.\n* Creatinine \\\u003C=1.5 X institutional ULN.\n* Absolute Neutrophil Count (ANC) \\>= 750\u002FmcL.\n* Platelet count \\>= 75,000\u002FmcL.\n* An absolute lymphocyte count (ALC) \\>=300\u002FmcL and CD3 plus cell count \\>=150\u002FmcL.\n* Normal cardiac ejection fraction as defined by \\>= 45 percent by echocardiogram (ECHO) at screening.\n* At least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 that has not been previously irradiated.\n* Recovered from acute toxic effects of all prior cancer therapy to Grade \\\u003C2 per Common Terminology Criteria for Adverse Events (CTCAE) v.6.0 at least one week before apheresis.\n* The following criteria must be met prior to apheresis:\n\n  * Chemotherapy and biologic\u002Ftargeted agents:\n\n    * \\>=14 days since the last dose of standard myelosuppressive chemotherapy.\n    * \\>= 7 days since the completion of biologic agent, targeted agent, or tyrosine kinase inhibitor therapy.\n    * \\>= 3 weeks or 5 half-lives (whichever is shorter) since prior therapy with a monoclonal antibody.\n  * Radiotherapy:\n\n    * \\>= 1 week since the last radiotherapy session.\n    * No washout period required for palliative radiation to non-target lesions.\n    * \\>= 3 weeks since hepatic radiation, chemoembolization, and\u002For radiofrequency ablation.\n  * Steroids and immunosuppressive therapy:\n\n    * Corticosteroids: \\>= 2 weeks since the therapeutic doses (\\> 0.5 mg\u002Fkg\u002Fday prednisone or equivalent). Note: Inhaled or topical steroids are not exclusionary.\n    * Physiologic replacement doses (up to 5 mg\u002Fday prednisone equivalent) are allowed and can be adjusted based on participant s BMI if warranted.\n    * \\>= 2 weeks since the other immunosuppressive medication (e.g., calcineurin inhibitors, methotrexate, rapamycin, thalidomide, etc.).\n  * Anti-PD-1 and any investigational therapies:\n\n    * \\>= 2 weeks since Anti-PD-1 monoclonal antibody therapy.\n    * \\>= 2 weeks or 5 half-lives of the investigational product (whichever is shorter) since any investigational treatment or clinical trial participation.\n  * Other criteria:\n\n    * 72 hours since small molecule tyrosine kinase inhibitors (e.g., EGFR inhibitors), PARP inhibitors, or KRAS G12C inhibitors.\n* Individuals of childbearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy.\n\nNote: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n\n* Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 7 months after the last dose of study drugs. We also will recommend individuals able to father a child with partners of childbearing potential ask partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study drug(s).\n* Ability of the participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of anaphylactic reactions attributed to anti-B7-H3 antibodies or compounds of similar chemical or biologic composition to autologous B7-H3 CAR T cells, cyclophosphamide, fludarabine, or other agents used in this study.\n* Infection exposure with the human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) as defined below:\n\n  * Positive serology for HIV.\n  * Active HBV infection as demonstrated by test for hepatitis B surface antigen (HBsAg).\n  * Positive serology for HCV.\n* Prior gene therapy using an integrating vector (except for autologous B7-H3 CAR T cells retreatment).\n* History of any previous allogeneic hematopoietic stem cell transplant.\n* Presence of fungal, bacterial, viral, or other infection is permitted if responding to active treatment.\n* Central Nervous System (CNS) disorder such as cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that may impair the ability to evaluate neurotoxicity.\n* Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in IOCBP at screening.\n* Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history, physical exam, electrocardiogram (ECG) or situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study.","ALL","18 Years","120 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nSmall cell lung cancer (SCLC) is the deadliest form of lung cancer. Extrapulmonary neuroendocrine cancer (EPNEC) is a similar type of cancer that develops anywhere other than the lungs. EPNEC is also deadly. B7-H3 is a protein often found in SCLC and EPNEC tumor cells. Researchers can modify a person s own T cells, or immune cells, to target B7-H3. When these modified T cells are returned to the body-a treatment called B7-H3 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells.\n\nObjective:\n\nTo test B7-H3 CAR T cell therapy in people with SCLC or EPNEC.\n\nEligibility:\n\nPeople aged 18 years and older with SCLC or EPNEC that either did not respond or returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have blood tests and tests of their heart function. They will have imaging scans.\n\nParticipants will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be altered to make them attack cells with B7-H3.\n\nParticipants will be in the hospital for at least 15 days. They will receive chemotherapy drugs to prepare their body for the treatment. These drugs will be given through a tube attached to a needle inserted into a vein.\n\nThe modified T cells will be infused through a vein. Participants will remain in the hospital until they are well enough to go home.\n\nFollow-up visits will continue for 15 years....",[27,28,29,30],"Extensive-Stage Small Cell Lung Cancer","Extrapulmonary Neuroendocrine Carcinoma","Recurrent or Refractory","Solid Tumors",[32,33,34,35],"B7-H3","CAR-T","Phase I","Immunotherapy","NOT_YET_RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":21},"2026-07-16",{"date":44,"type":21},"2031-01-30",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",1,{"id":50,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":25,"conditions":53,"keywords":54,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":61,"locationsCount":48},"100632080",{"count":20,"type":21},[24],[27,28,29,30],[32,33,34,35],"2026-07-01",{"date":57,"type":40},"2026-07-02",{"date":59,"type":21},"2026-07-07",{"date":44,"type":21},{"name":46,"class":47},{"id":63,"slug":4,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":7},"100480450","NCT05536141","A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors","A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors","ARC-20","Key Inclusion Criteria:\n\n* Must have at least one measurable lesion per RECIST guidance\n* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1\n* Disease-specific criteria for dose escalation:\n\n  * Participants may have any pathologically confirmed solid tumor type where no other treatment options are available\n  * Creatinine clearance ≥ 40 mL\u002Fmin\n\nDisease-specific criteria for dose-expansion:\n\n* Histologically confirmed ccRCC\n* Creatinine clearance ≥ 40 mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product\n* Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous\n* History of trauma or major surgery within 28 days prior to the first dose of investigational product\n* For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":70,"type":21},362,[24],"The purpose of this study is to evaluate the safety and tolerability of:\n\n* casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and\n* casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.",[74,30],"Clear Cell Renal Cell Carcinoma",[74,76,77,78,79,80,81],"AB521","Casdatifan","Kidney Cancer","Zimberelimab","AB122","Hif2a","RECRUITING",{"date":57,"type":40},{"date":85,"type":40},"2022-10-26",{"date":87,"type":21},"2029-03",{"name":89,"class":90},"Arcus Biosciences, Inc.","INDUSTRY",{"id":92,"slug":4,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":48},"100313872","NCT03366116","5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors","Phase I Trial of 5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in Patients With Advanced Solid Tumors","* INCLUSION CRITERIA:\n* Patients must have histologically documented solid tumors whose disease has progressed on standard therapy or for which there is no available standard therapy.\n* Age \\>=18 years of age.\n* ECOG performance status \\\u003C= 2.\n* Patients must have normal organ and marrow function as defined below:\n\n  * absolute neutrophil count \\>= 1,500\u002FmcL\n  * platelets \\>=100,000\u002FmcL\n  * total bilirubin \\\u003C=1.5 X institutional upper limit of normal (\\\u003C=3 x upper limit of normal in the presence of documented Gilbert s syndrome)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=3 X institutional upper limit of normal\n\nOR\n\n* AST(SGOT)\u002FALT(SGPT) \\\u003C=5 X institutional upper limit of normal for patients with liver metastases\n* creatinine \\\u003C=1.5X institutional upper limit of normal\n\nOR\n\n* creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above 1.5X institutional normal\n\n  * Because nucleoside analogs are known to be teratogenic, women of child-bearing potential and men must agree to use two forms of contraception (hormonal or barrier method of birth control; abstinence; sterilization) prior to study entry, for the duration of study participation, and for 3 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use two forms of contraception prior to the study, for the duration of study participation, and for 3 months after completion of administration of Aza-TdC.\n  * Patients must have completed any chemotherapy or biologic therapy \\>= 4 weeks or 5 half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Patients must be \\>= 2 weeks since any prior palliative radiation or cyberknife therapy. Patients must have recovered to grade 1 from prior toxicity or adverse events. Patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI's discretion. Patients with bone metastases or hypercalcemia on intravenous bisphosphonate treatment prior to study entry may continue this treatment.\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Willingness to provide blood and urine samples for research purposes.\n  * Ability to swallow pills\u002Fcapsules.\n  * Left ventricular ejection fraction greater than 45% or the institutional lower limit of normal by either ECHO or MUGA at entry.\n  * For patients enrolled on the expansion cohort, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or H \\& N lesions under visualization) and willingness to undergo tumor biopsies.\n\nEXCLUSION CRITERIA:\n\n* Patients who are receiving any other investigational agents.\n* Pregnant women and women who are breastfeeding are excluded from this study.\n* Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, known HIV infection requiring protease inhibitor therapy, known Hepatitis B, known Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:\n\n  * Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:\n\n    * Evaluable or measurable disease outside the CNS\n    * No metastases to brain stem, midbrain, pons, medulla, or cerebellum\n    * No history of intracranial hemorrhage or spinal cord hemorrhage\n    * No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.\n    * No neurosurgical resection or brain biopsy within 28 days prior to Cycle 1, Day 1\n  * Patients with treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:\n\n    * No stereotactic radiation or whole-brain radiation within 14 days prior to Cycle 1, Day 1\n    * Screening CNS radiographic study 2 weeks from completion of radiotherapy and \\>=1 week from discontinuation of corticosteroids. The presence of new CNS mets will not exclude the patient but provide a baseline. If the irradiated lesion showed increased edema or growth, patient may be enrolled if asymptomatic but a repeat MRI should be done within the next 2-4 weeks for follow up.\n* Malabsorption syndrome or other conditions that would interfere with intestinal absorption.",{"count":98,"type":21},65,[24],"Background:\n\nBlood, tissue, and tumor cells contain genes. Genes are made up of DNA. DNA is the \"instruction book\" for each cell. In some people with cancer, the genes that might have slowed the growth of their tumor were \"turned off.\" Researchers want to see if a new drug can turn the genes back on and slow the tumor growth. The drug is called Aza-TdC.\n\nObjective:\n\nTo test the safety of Aza-TdC, and to find out the dose of this drug that can be safely given to humans.\n\nEligibility:\n\nPeople ages 18 and older who have advanced cancer that has gotten worse after standard treatment, or for which no effective therapy exists\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nBlood and urine tests\n\nScans to measure their tumors\n\nTest to measure the electrical activity of the heart\n\nParticipants will take the study drug by mouth. The drug is given in cycles. Each cycle is 21 days (3 weeks) long.\n\nWeek 1 and week 2: participants will take the study drug once a day for 5 days. Then they will have 2 days without the drug. Week 3: no study drug is taken. This completes one cycle of treatment.\n\nFor cycle 1, participants will repeat the screening tests several times. For all other cycles, participants will have blood tests and pregnancy tests. They will have scans of their tumor every 6 weeks.\n\nThe cycle will be repeated as long as the participant tolerates the drug and the cancer is either stable or gets better.\n\nSponsoring Institute: National Cancer Institute\n\n...",[102,30],"Neoplasms",[104,105,106,107,108],"Pharmacodynamics","DNA Methylation","Pharmacokinetics","Nucleoside Analog","Epigenetics",{"date":57,"type":40},{"date":111,"type":40},"2018-11-05",{"date":113,"type":21},"2026-09-30",{"name":46,"class":47},{"id":116,"slug":4,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100633083","NCT07522073","A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma","A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)","DAWN-303","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation\n* No prior systemic treatment in the metastatic setting\n* ECOG Performance status 0-1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with any KRAS inhibitor\n* Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug\n* Known active CNS metastases\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":123,"type":21},588,[125],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).",[30],[129,130,131,132,133,134,135,136],"INCB161734","KRASG12D Mutation","pancreatic ductal adenocarcinoma (PDAC)","KRAS G12D inhibitor","KRAS inhibitor","KRAS mutation","pancreatic cancer","metastatic pancreatic cancer","2026-06-29",{"date":139,"type":40},"2026-06-30",{"date":141,"type":40},"2026-04-09",{"date":143,"type":21},"2029-03-19",{"name":145,"class":90},"Incyte Corporation",217,{"id":148,"slug":4,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100624853","NCT07415031","A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies","Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)","Inclusion Criteria:\n\n* Participant is eligible to receive continued study treatment as per the parent study, and\u002For investigator assessed clinical benefit.\n* Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF.\n\nExclusion Criteria:\n\n* Participant is not eligible for study treatment per the parent study eligibility criteria.\n* Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study.\n* Participants not receiving clinical benefit from parent study drug as assessed by the investigator.\n\nOther protocol defined inclusion\u002Fexclusion criteria applies.",{"count":154,"type":21},170,[156],"PHASE2","This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.",[30],[160,161,162,163,164,165],"Adagrasib","KRAS G12C","KRAS","NSCLC","CRC","Krazati",{"date":139,"type":40},{"date":168,"type":40},"2026-05-06",{"date":170,"type":21},"2028-02-16",{"name":172,"class":90},"Mirati Therapeutics Inc.",100,{"id":175,"slug":4,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},"100608004","NCT07195916","A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies","A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies","Inclusion Criteria:\n\n* Age ≥18 years.\n* ECOG performance status of 0 or 1.\n* Histologically confirmed:\n\n  * Clear cell renal cell carcinoma (ccRCC).\n  * Diffuse large B-cell lymphoma (DLBCL, NOS).\n  * High-grade B-cell lymphoma (HGBCL).\n  * Peripheral T-cell lymphoma (PTCL, incl. NOS and ALCL).\n  * Cutaneous T-cell lymphoma (CTCL, incl. MF or SS ≥Stage IIB with B0\u002FB1 blood involvement).\n* Disease progression, relapse, or refractory to prior therapy:\n\n  * ccRCC: ≥1 prior line incl. ICI + TKI.\n  * DLBCL\u002FHGBCL: ≥2 prior lines incl. immunochemotherapy and salvage.\n  * PTCL\u002FCTCL: ≥1 prior systemic therapy.\n* Measurable disease by RECIST v1.1 (ccRCC), Lugano 2014 (lymphomas), or ISCL\u002FUSCLC\u002FEORTC (CTCL).\n* Tumor tissue available for central testing.\n\nExclusion Criteria:\n\n* Untreated or progressive CNS disease unless previously treated and stable.\n* Other active invasive malignancy within 2 years (except certain low-risk cancers).\n* Prior CD70-targeting therapy, including CAR T.\n* ASCT or CAR T ≤12 weeks before enrollment; prior organ or allogeneic transplant.\n* Unresolved ≥Grade 2 toxicity from prior therapy (with exceptions).\n* Primary immunodeficiency or active autoimmune disease requiring immunosuppression.\n* Active HBV, HCV, HIV, or other chronic infections requiring systemic therapy.\n* Pregnancy, breastfeeding, or unwillingness to use effective contraception.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":181,"type":21},280,[24],"A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.",[30,185],"Hematologic Malignancies",[187,188,189,190,191,192,193,194,195,196,35,197],"Advanced solid tumors","Metastatic solid tumors","Clear cell renal cell carcinoma (ccRCC)","Diffuse large B-cell lymphoma (DLBCL)","High-grade B-cell lymphoma (HGBCL)","Peripheral T-cell lymphoma (PTCL, incl. ALCL)","Cutaneous T-cell lymphoma (CTCL, incl. MF and SS)","Non-Hodgkin lymphoma (NHL)","CD70","Bispecific antibody","T-cell engager",{"date":139,"type":40},{"date":200,"type":40},"2026-01-08",{"date":202,"type":21},"2028-08-18",{"name":145,"class":90},22,{"id":206,"slug":4,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"100323125","NCT03486873","Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587\u002FKEYNOTE-587)","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and\u002For complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\\u003C150\u002F90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant\u002Fbreastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g\u002F24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.",{"count":212,"type":21},3500,[125],"The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.",[30,185],[217,218,219,220],"PD1","PD-1","PDL1","PD-L1","2026-06-25",{"date":223,"type":40},"2026-06-26",{"date":225,"type":40},"2018-08-21",{"date":227,"type":21},"2043-08-04",{"name":229,"class":90},"Merck Sharp & Dohme LLC",782,{"id":232,"slug":4,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":98},"100549252","NCT06431594","A Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Participants With Advanced Solid Tumors (BEHOLD-1)","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Males or females aged 18 years or older (≥18 years).\n* Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care.\n* PROC cohort\n\n  1. Histologically documented, advanced (metastatic and\u002For unresectable) high-grade serous\u002Fendometrioid ovarian, primary peritoneal, or fallopian tube cancer.\n  2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy.\n  3. Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy.\n  4. Must have had prior bevacizumab , unless there is a documented contraindication or intolerance.\n  5. Participants with known Folate receptor-α (FR-α) expressing tumors must have received mirvetuximab soravtansine if the regimen is locally available, unless there is a documented contraindication or intolerance.\n\nParticipants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the regimen is locally available, unless there is a documented contraindication or intolerance.\n\n* Endometrial cancer cohort\n\n  1. Histologically documented, advanced (metastatic and\u002For unresectable) or recurrent endometrial cancer.\n  2. Must have received or are intolerant to 1 but no more than 4 lines of prior systemic therapy.\n  3. Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in separate regimens), if the regimen is locally available, unless there is a documented contradiction or intolerance\n  4. All epithelial histologies are permitted including carcinosarcoma.\n* Participants have at least one target lesion as assessed per the RECIST 1.1\n* Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by IHC in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose.\n* Have a life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n* Have received any B7-H4-targeted therapy\n* Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.\n* Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.\n* Presence of pleural\u002Fabdominal effusion\u002Fascites requiring clinical intervention; presence of pericardial effusion\n* Major surgery within 28 days prior to the first dose of study treatment.\n* Evidence of brain metastasis unless asymptomatic;\n* Has inadequate bone marrow reserve or hepatic\u002Frenal functions .\n* Mean Fridericia-corrected QT interval (QTcF) QTcF \\>450 msec or QTcF \\>480 msec for participants with bundle branch blocK;\n* Evidence of current clinically significant arrhythmias or ECG abnormalities\n* Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events\n* Has current active pneumonitis\u002FILD or any history of ILD, any history of pneumonitis requiring steroids or immunomodulatory treatment within 90 days of planned randomization\u002Fenrollment or any history of drug-induced pneumonitis\u002FILD.Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs)\n* PROC\n\n  1. Primary platinum refractory disease defined as those who have progressed on or within 12 weeks of last dose of first line platinum therapy not permitted.\n  2. Non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma not permitted.\n* Endometrial cancer a. Mesenchymal tumors of the uterus (uterine sarcomas) not permitted.",{"count":238,"type":21},675,[24],"The goal of this study is to assess the safety and tolerability of Mocertatug Rezetecan . The study will also see how the levels of Mo-Rez change over time at different dose amount",[30,102],[30,243,244,245,246],"Mocertatug rezetecan","Mo-Rez","GSK5733584","BEHOLD-1","2026-06-23",{"date":221,"type":40},{"date":250,"type":40},"2024-07-02",{"date":252,"type":21},"2029-12-31",{"name":254,"class":90},"GlaxoSmithKline",{"id":256,"slug":4,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":261,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100406285","NCT04570423","A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","Inclusion Criteria:\n\n1. Participant must have a pathologic\u002Fhistologic confirmed newly diagnosed\u002Frelapsed\u002Frecurrent solid tumor or lymphoma without bone marrow involvement.\n2. Participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines.\n3. Participant has adequate hematological, renal, and hepatic function.\n4. Participant must have an echocardiogram (ECHO) or multigated acquisition (MUGA) within 14 days of Screening if receiving a cardiotoxic therapy and have a cardiac ejection fraction of \\>50%.\n5. Participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (CNS) involvement within 14 days of study entry.\n6. Participant has a Karnofsky performance level ≥50% for patients ≥16 years of age or a Lansky performance level ≥50 for children \\\u003C16 years of age.\n\nExclusion Criteria:\n\n1. Participant has an uncontrollable infection, has an underlying medical condition, and\u002For another serious illness that would impair the ability of the participant to receive protocol-specified treatment.\n2. Participant has had previous exposure to filgrastim (within 7 days), pegfilgrastim (within 14 days), or other granulocyte colony stimulating factor (G-CSF) products in clinical development within 2 weeks prior to the administration of study drug (eflapegrastim)\n3. Participant requires concurrent radiation therapy specifically in Cycle 1.\n4. Participant has had prior bone marrow or hematopoietic stem cell transplant and\u002For has concurrent bone marrow involvement in their malignancy, including leukemia.\n5. Participant has had spinal radiation therapy within 30 days prior to study enrollment.\n6. Participant has used any investigational drugs, biologics or devices within 30 days prior to study treatment or plans to use any of these during the study.\n7. Participant has a known sensitivity or previous reactions to any of the G-CSF products.\n8. Participant with active CNS disease.\n9. Participant has not recovered from previous treatment adverse events to ≤Grade 1.","1 Month","17 Years",{"count":20,"type":21},[156],"The purpose of this study is to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphoma and treated with myelosuppressive chemotherapy.",[30,267],"Lymphoma",[269,30,270],"Lymphomas","Chemotherapy",{"date":272,"type":40},"2026-06-24",{"date":274,"type":40},"2021-05-20",{"date":276,"type":21},"2027-10",{"name":278,"class":90},"Spectrum Pharmaceuticals, Inc",5,{"id":281,"slug":4,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":22,"phases":288,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100621763","NCT07374848","Phase 1a\u002Fb Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors","An Open-label, Phase 1a\u002Fb, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants With Sarcoma and Selected Solid Tumors","Inclusion Criteria:\n\n* Adult men and women ≥18 years of age at the time of signing the ICF with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy \\> 3 months\n* Participants must have histologically confirmed and documented diagnosis of locally advanced unresectable and\u002For metastatic sarcoma or a selected solid tumor\n* Participants must be willing to undergo a tumor biopsy prior to start of treatment or provide archived tumor tissue sample\n* Participants with sarcoma should have received no more than 2 lines of previous systemic therapies in the metastatic setting\n* Participants with selected epithelial solid tumors should have received no more than 3 lines of previous systemic therapy in the metastatic\u002Frelapsed refractory setting\n* Participants must have at least one measurable target lesion as defined by RECIST v1.1\n* Adequate organ and marrow function as listed per protocol\n* Must be negative for HIV, HBV, and HCV\n\nExclusion Criteria:\n\n* Participants with another known malignancy that has required treatment within the last 2 years\n* Symptomatic central nervous system (CNS) metastasis, and\u002For those requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n* Participants with leptomeningeal metastasis\n* Most recent systemic anti-cancer treatment or investigational products\u002Fdevices less than 3 weeks\n* Prior treatment with a topoisomerase-1 inhibitor antibody drug conjugate\n* Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment\n* Clinically significant pulmonary disease including autoimmune, connective tissue, or inflammatory conditions\n* Pregnant or nursing (lactating) women",{"count":287,"type":21},180,[24],"The purpose of this study is to evaluate the safety and tolerability of investigational study drug ZL-6201 for treating sarcoma and solid tumors cancer.",[30,291],"Sarcomas",[293,30,294,295,296],"Sarcoma","Phase1","Antibody-Drug Conjugate (ADC)","Leucine-Rich Repeat-Containing protein 15 (LRRC15)","2026-06-18",{"date":299,"type":40},"2026-06-22",{"date":301,"type":40},"2026-03-02",{"date":303,"type":21},"2029-09",{"name":305,"class":90},"Zai Lab (Shanghai) Co., Ltd.",6,{"id":308,"slug":4,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":4},"100641720","NCT07661459","Optimizing Ancillary Therapies With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)","Optimizing Ancillary Therapies (Acetaminophen, Cannabis, Antihistamines, and NSAIDS) With Immune Checkpoint Inhibitors for Solid Tumors (OAT ICI)","OAT ICI","Inclusion Criteria:\n\n* Solid tumor patients with measurable disease. Including patients with early stage and advanced stage cancer.\n* Patients who are to get neoadjuvant or induction therapy prior to planned surgery or radiation are included if definitive therapy is planned to occur at least 18 weeks after ICI initiation.\n* Treatment plan includes an immune checkpoint inhibitor (PD1 or PD-L1 inhibitor) as standard of care. Standard of care will be determined by referring to the NCCN guidelines. For rare situations where a disease is not found in the NCCN guideline, the treatment must be considered standard of care at the MCC.\n* ECOG Performance Status 0-3.\n* Life expectancy of at least 3 months.\n* Adequate hematologic, renal and hepatic function based on institutional standards.\n* Must be willing to stop\u002Fnot start daily acetaminophen during the study period\n* Must be willing to stop\u002Fnot start THC-containing agent (e.g., medical or recreational marijuana, CBD) during the study period\n* Patients willing to take a second-generation antihistamine (loratadine) and an NSAID (aspirin). Patients already taking a daily antihistamine and\u002For NSAID can participate and will continue the class of drug already being taken\n* Ability to understand and the willingness to follow study procedures, including urine testing for THC.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Contraindication to immunotherapy, aspirin, or loratadine (including patients on blood thinners or antiplatelet agents that pose a high risk of bleeding based on the treating oncologist's opinion)\n* History of allergic reactions attributed to loratadine or aspirin (true allergy, not intolerance)\n* Known immunocompromised patients; defined as disease or drug related. This includes solid organ transplant patients, patients with active human immunodeficiency virus (detectable disease within the last 60 days), and those with autoimmune diseases on immune modulating drugs (disease modifying agents or steroids at a prednisone equivalent dose \\> 10 mg daily).\n* Early-stage disease patients who are scheduled for definitive therapy in less than 126 days from treatment initiation\n* Patients must not have had prior ICIs for advanced disease except as neoadjuvant + adjuvant therapy. Patients with recurrence after definitive therapy may have had prior ICIs for earlier stage disease if it was \\> 6 months since the last dose.\n* Patients on an interventional cancer study\n* History or evidence of any other clinically significant condition that, in the opinion of the investigator or treating physician, would pose a risk to subject safety or interfere with study procedures, evaluation or completion","99 Years",{"count":316,"type":21},98,[156],"This study evaluates whether optimization of ancillary therapies can improve the efficacy of immune checkpoint therapy in participants with solid tumors. The ancillary therapies being optimized include the avoidance of daily acetaminophen and cannabis\u002FTHC\u002FCBD while prescribing aspirin and loratadine. The goal is to see if optimizing these four drugs can improve the efficacy of the treatment compared to a matched historical control.",[30],"2026-06-16",{"date":299,"type":40},{"date":323,"type":21},"2026-06",{"date":325,"type":21},"2027-07-31",{"name":327,"class":328},"Val Adams","OTHER",{"id":330,"slug":4,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":335,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":22,"phases":338,"briefSummary":339,"conditions":340,"keywords":344,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":279},"100564996","NCT06636435","A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer","A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.","Inclusion Criteria:(Part 1-4)\n\n* Patients who provide voluntary written informed consent to participate in the study\n* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1\n* Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)\n* Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: Neutrophil count;≥1500\u002FμL, Platelet count; ≥75000\u002FμL, Hemoglobin;≥9.0 g\u002FdL.\n* Patients having Solid Tumors with no standard therapy available or refractory or intolerable to standard therapy (Part2, 3)\n* Patients with Child-Pugh A or B (Part2, 3)\n* Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4)\n\nInclusion Criteria:(Part 5)\n\n* Patients who provide voluntary written informed consent to participate in the study from both the subject (if aged 16 years or older) and their legal representatives\n* Japanese patients aged 2 years or older and under 20 years at the time of informed consent\n* Patients with a Lansky Performance Status (LPS) of ≥70 (for patients aged 15 years or younger) or a Karnofsky Performance Status (KPS) of ≥70 (for patients aged 16 years or older)\n* Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (eGFR ≥60 mL\u002Fmin\u002F1.73 m²)\n* Pediatric patients with cancers with no standard therapy available or refractory or intolerable to the standard therapy\n\nExclusion criteria: (Part1-5)\n\n* Patients who have undergone major surgery within 28 days before enrollment\n* Patients who have received anticancer treatment with surgical therapy, radiation therapy, and\u002For drug therapy within 14 days before enrollment\n* Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment\n* Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity\n* Patients who have received any other investigational product within 28 days before enrollment\n* Patients with current or previous inadequately controlled or clinically significant cardiac disease\n* Patients who, in the opinion of the investigator or subinvestigator, is not appropriate","2 Years",{"count":337,"type":21},66,[24],"In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.",[30,341,342,343],"Hepatocellular Carcinoma (HCC)","Malignant Melanoma","Pediatric Cancer",[345,346,34,347,348,349,350,351,343],"DLK1","First in human","Antibody","solid tumor","Hepatocellular Carcinoma","CBA-1205","Melanoma","2026-06-15",{"date":354,"type":40},"2026-06-17",{"date":356,"type":40},"2020-06-01",{"date":358,"type":21},"2027-06-30",{"name":360,"class":90},"Chiome Bioscience Inc.",{"id":362,"slug":4,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":4},"100641305","NCT07657611","Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors","A Platform Study of In Vivo Inhaled mRNA Technology for Multi-Target Immunotherapy Against Solid Tumors","BMD-PLAT","Inclusion Criteria:\n\n1. Male or female patients aged ≥ 18 years.\n2. Confirmed diagnosis of advanced lung cancer (driver gene negative or targeted therapy failed) or pulmonary metastatic solid tumors, with no standard treatment options available or who have failed prior standard therapies.\n3. Presence of at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Adequate organ function, including hematologic, hepatic, and renal function.\n6. Ability to understand and sign the informed consent form.\n7. Expected survival of at least 12 weeks.\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity to mRNA-based therapies or components of the study drug.\n2. Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids).\n3. Prior allogeneic stem cell or solid organ transplantation.\n4. Current use of other investigational agents within 4 weeks before the first dose of study treatment.\n5. Active autoimmune disease requiring systemic immunosuppressive therapy.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, would interfere with study compliance or safety.",{"count":369,"type":21},60,[371],"EARLY_PHASE1","This is an open-label phase I master platform study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of multiple inhaled in-vivo mRNA immunotherapies in adult patients with advanced solid tumors. Subjects will receive inhalation mRNA formulations at ascending dose levels following a 3+3 dose-escalation design to determine maximum tolerated dose and recommended phase II dose.",[102,30,374],"Neoplasm Metastasis","2026-06-14",{"date":297,"type":40},{"date":378,"type":21},"2026-06-10",{"date":380,"type":21},"2029-12",{"name":382,"class":328},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":384,"slug":4,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":403},"100624937","NCT07416123","A Study of GEN1106 in Participants With Solid Tumors","First-In-Human, Open-Label, Dose Escalation and Expansion Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of GEN1106 in Participants With Solid Tumors","Key Inclusion Criteria:\n\n* Have progressed on or after standard of care (SoC) therapy, which should include chemotherapy, anti-programmed cell death protein 1 (PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) therapies, and enfortumab vedotin (EV), if applicable for the tumor type, or for whom there is no available standard therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1106 may be beneficial, in the opinion of the investigator.\n* Have measurable disease according to RECIST v1.1.\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening.\n* Part 1: Have histologically or cytologically confirmed diagnosis of cancer as specified per protocol.\n* Parts 2 and 3: Have histologically or cytologically confirmed diagnosis of metastatic urothelial carcinoma (mUC).\n\nKey Exclusion Criteria:\n\n* Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) therapy.\n* Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.\n* Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or lower, except for alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to grade 2.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":390,"type":21},103,[24],"The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when it is used for the treatment of participants with certain types of cancer.\n\nThe trial has multiple parts. The first part of the trial tests different doses of GEN1106 to find out if it is safe and determine what are the best doses to use. The second and third parts continues to test the safety of and how well GEN1106 works in additional participants with a specific cancer type and at doses chosen based on results from the first part of the trial.\n\nFor each participant, the trial will last approximately 17 months but will vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 5 months of treatment (the duration of treatment may vary for each participant), and approximately 11 months of follow up after trial treatment ends (the duration of follow up may vary for each participant).\n\nParticipation in the trial will require visits to the site, with more frequent visits during the first 6 weeks of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography \\[CT\\] scans) to monitor whether the treatment is safe and effective.\n\nAll participants will receive active drug; no one will be given placebo.",[30,394],"Urothelial Carcinoma","2026-06-12",{"date":352,"type":40},{"date":398,"type":40},"2026-04-14",{"date":400,"type":21},"2029-06-25",{"name":402,"class":90},"Genmab",8,{"id":405,"slug":4,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":22,"phases":413,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":423,"leadSponsor":425,"locationsCount":48},"100642350","NCT07649200","Study of SNH-118110 in Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SNH-118110 in Patients With Advanced Solid Tumors","SNH-118110","Inclusion Criteria:\n\n* Ability to understand and voluntarily sign an informed consent form (ICF) prior to any study related procedures.\n* Age ≥ 18 years at the time of signing the ICF.\n* Histologically or cytologically confirmed diagnosis of advanced solid tumors, with the following additional requirements:\n\nDose-escalation phase: Patients with advanced solid tumors harboring a RET gene alteration who have failed standard therapy or are intolerant to standard therapy.\n\nDose-expansion phase:\n\nCohort 1: Locally advanced or metastatic NSCLC with RET gene fusion who have progressed after at least one prior line of therapy, which must include a RET inhibitor.\n\nCohort 2: Treatment-naïve patients with locally advanced or metastatic NSCLC harboring a RET gene fusion.\n\nCohort 3: Other advanced solid tumors harboring RET gene alterations.\n\n* At least one measurable target lesion according to RECIST version 1.1.\n* Documentation of a RET fusion or other activating RET gene alteration (based on a local or central laboratory report).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within the 2 weeks prior to the first dose of study drug.\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Presence of other known oncogenic driver mutations.\n* Prior anti-tumor therapy within specified washout periods prior to first dose (e.g., small molecules, biologics, radiotherapy, major surgery), or failure to recover from clinically significant toxicities.\n* Clinically significant uncontrolled or active conditions, including but not limited to:\n\nInadequate bone marrow, hepatic, or renal function. Significant cardiovascular disease (e.g., uncontrolled hypertension, prolonged QTc, poor ejection fraction, recent thromboembolic events).\n\nActive or uncontrolled infections, bleeding diathesis, or significant pleural\u002Fabdominal\u002Fpericardial effusion requiring intervention.\n\nCentral nervous system metastases unless stable and asymptomatic off steroids.\n\n* Conditions affecting oral drug absorption or gastrointestinal function.\n* History of severe allergic reactions to similar agents.\n* Pregnant or lactating women, or patients with serious concurrent medical or psychiatric conditions that would compromise safety or study compliance.",{"count":412,"type":21},240,[24],"This is a multicenter, open-label, Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SNH-118110 administered orally. The study consists of a dose-escalation phase and a dose-expansion phase.",[30],[417,418,419],"Advanced Solid Tumors","Medullary Thyroid Cancer","Non-Small Cell Lung Cancer","2026-06-11",{"date":320,"type":40},{"date":223,"type":21},{"date":424,"type":21},"2029-06-26",{"name":426,"class":90},"ScinnoHub Pharmaceutical Co., Ltd.",{"id":428,"slug":4,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":448,"leadSponsor":450,"locationsCount":4},"100643410","NCT07639801","68Ga-FAPI-PSMA PET Imaging for the Diagnosis of Solid Tumors","Evaluation of Dual-Targeted 68Ga-FAPI-PSMA PET\u002FCT for the Diagnosis and Staging of Solid Tumors","Inclusion Criteria:\n\n* Age 18-75 years\n\n  * Patients with suspected or confirmed solid tumors (e.g., prostate cancer, hepatocellular carcinoma, ovarian cancer, or endometrial cancer)\n  * Patients scheduled to undergo tumor biopsy or surgical treatment within 2 months\n  * ECOG performance status of 0 or 1\n  * Expected survival of at least 12 weeks\n  * Adequate hematologic and organ function:\n  * White blood cell count ≥ 4.0 × 10\\^9\u002FL or neutrophils ≥ 1.5 × 10\\^9\u002FL\n  * Platelet count ≥ 100 × 10\\^9\u002FL\n  * Hemoglobin ≥ 90 g\u002FL\n  * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n  * ALT\u002FAST ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)\n  * Creatinine ≤ 1.5 × ULN\n  * At least one measurable lesion according to RECIST 1.1 criteria\n  * Ability to understand the study procedures and willingness to sign written informed consent\n\nExclusion Criteria:\n\n* Severe hepatic or renal dysfunction\n* Inability to remain in a supine position for approximately 30 minutes during PET\u002FCT scanning\n* Refusal or inability to participate in the clinical study\n* Claustrophobia or severe psychiatric disorders that would interfere with imaging procedures\n* Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study","75 Years",{"count":435,"type":21},20,[437],"NA","This study aims to evaluate a novel dual-targeted PET imaging tracer, 68Ga-FAPI-PSMA, for the detection and evaluation of solid tumors. Fibroblast activation protein (FAP) and prostate-specific membrane antigen (PSMA) are two important molecular targets that are highly expressed in tumor cells or the tumor microenvironment. Combining these two targets into a single imaging probe may improve the sensitivity and accuracy of tumor detection.\n\nIn this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET\u002FCT imaging using 68Ga-FAPI-PSMA. The imaging results will be compared with standard PET tracers such as 68Ga-PSMA-617 or 68Ga-FAPI-04. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-FAPI-PSMA PET\u002FCT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.",[440,349,441,30,442,443,444],"Prostate Cancer","Ovarian Cancer","Endometrial Cancer","FAPI","PSMA","2026-06-06",{"date":378,"type":40},{"date":323,"type":21},{"date":449,"type":21},"2026-12-31",{"name":451,"class":328},"Peking University Cancer Hospital & Institute",{"id":453,"slug":4,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":16,"minAge":458,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":462,"conditions":463,"keywords":467,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":485},"100477963","NCT05503797","A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations","A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations","Inclusion Criteria\n\nSubprotocol A:\n\n1. Male and female, ≥10 years of age, and weighing ≥30 kg.\n2. Histologic diagnosis of a solid tumor or primary CNS tumor.\n3. Documentation of BRAF gene fusion in tumor and\u002For blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing.\n4. Have an archival tissue sample available meeting protocol requirements.\n5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.\n6. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.\n7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline.\n\nSubprotocol B:\n\n1. Male and female, ≥10 years of age, and weighing ≥30 kg.\n2. Histological diagnosis of a primary CNS tumor, including but not limited to the following:\n\n   1. Adults (≥18 years) with Grade 1-4 glioma or glioneuronal tumor (including glioblastoma, anaplastic astrocytoma, high grade astrocytoma with piloid features, pilocytic astrocytoma, gliosarcoma, anaplastic pleomorphic xanthoastrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, not otherwise specified \\[NOS\\], ganglioglioma, or recurrent LGG). OR\n   2. Pediatric patients (10-17 years of age) with a Grade 3 or 4 glioma or glioneuronal tumor, including those with a prior, histologically confirmed, diagnosis of a low-grade glioma or glioneuronal tumor and now have radiographic or histopathological findings consistent with WHO \\[2021\\] Grade 3 or 4 primary CNS tumor.\n   3. Participants must have unresectable, locally advanced or metastatic disease that:\n\n   i. Had prior treatment with radiotherapy and\u002For first-line chemotherapy or concurrent chemoradiation therapy OR\n   * Note: Participants who have a WHO Grade 3 or 4 glioma for whom chemotherapy and\u002For radiotherapy is not considered standard of care may remain eligible for the study.\n\n   ii. Is intolerant to available therapies OR iii. The investigator has determined that treatment with standard therapy is not appropriate.\n3. Documented BRAF V600E mutation in tumor and\u002For liquid biopsy detected by an analytically validated test at CLIA or CLIA-equivalent laboratory approved by sponsor or sponsor-designated central test.\n4. An archival tissue sample available meeting protocol requirements, or fresh biopsy is required if the archival sample is not available for retrospective confirmation test.\n5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.\n6. Measurable disease based upon specified response criteria, as determined by the radiographic BICR.\n7. All adverse events related to prior therapies (eg, chemotherapy, radiotherapy, surgery) must have resolved to Grade 1 or baseline.\n8. Participants who are receiving corticosteroid treatment must be on a stable or decreasing dose of ≤8 mg\u002Fday of dexamethasone or equivalent corticosteroid treatment for 7 days prior to first dose of study treatments.\n\nSubprotocol C:\n\n1. Male and female, ≥10 years of age, and weighing ≥30 kg.\n2. Histologic diagnosis of a rare BRAF V600E-mutated solid tumor that is unresectable, locally advanced or metastatic.\n3. Measurable disease on CT, MRI, or physical exam\n4. Documented BRAF V600E mutation in tumor and\u002For liquid biopsy detected by an analytically validated test.\n5. Have an archival tissue sample available meeting protocol requirements.\n6. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory\n7. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.\n\nSubprotocol D:\n\n1. Male and female, 18 - 65 years of age.\n2. Histologic diagnosis of a solid tumor harboring a BRAF V600E mutation and not eligible for other subprotocols.\n3. Measurable disease on CT, MRI, or physical exam.\n4. Evidence of BRAF V600E mutation in tumor and\u002For blood detected by genomic tests.\n5. Consent to provide a tumor biopsy.\n6. Willingness to comply with the ECG substudy procedures.\n7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline.\n\nExclusion Criteria:\n\nSubprotocol A:\n\n1. Prior treatment with RAF\u002FBRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease.\n2. Prior treatment with a MEK inhibitor.\n3. Tyrosine kinase inhibitor(s) and\u002For targeted therapies are allowed (other than BRAF\u002FMAPK pathway inhibitors per Exclusion Criteria 3 and 4) and will be restricted to no more than the number of lines of therapy that are consistent with standard treatment guidelines.\n4. Malignancy with co-occurring activating RAS mutation(s) at any time.\n5. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n6. HIV infection with exceptions; discuss with treating physician.\n7. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection).\n8. Grade ≥2 changes in AST, ALT, GGT, or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.\n\nSubprotocol B:\n\n1. Prior treatment with BRAF, ERK, and\u002For MEK inhibitor(s).\n2. Known or suspected neurofibromatosis-1 (NF-1) and\u002For RAS related gene alterations.\n3. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n4. Active infection requiring systemic therapy.\n5. HIV infection with exceptions; discuss with treating physician.\n6. Have impairment of GI function or GI disease that may significantly alter the absorption of oral plixorafenib (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).\n7. Grade ≥ 2 changes in AST, ALT, gamma-glutamyl transaminase (GGT), or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.\n\nSubprotocol C:\n\n1. Diagnosis of colorectal adenocarcinoma or pancreatic ductal adenocarcinoma (neuroendocrine or acinar tumors are eligible).\n2. Diagnosis of BRAF V600E-mutated cutaneous melanoma, papillary thyroid cancer, or NSCLC.\n3. Participant has CNS metastases.\n4. Prior treatment with BRAF, ERK, and\u002For MEK inhibitor(s), unless otherwise specified for specific tumor types (i.e. low grade serous or borderline ovarian cancer).\n5. Known or suspected neurofibromatosis-1 (NF-1) and\u002For RAS related gene alterations.\n6. Participants with prostate, breast, or gynecologic cancers with known activating mutations that lead to constitutive hormone receptor activation (AR-V7, ESR1).\n7. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n8. Active infection requiring systemic therapy.\n9. HIV infection with exceptions; discuss with treating physician.\n\nSubprotocol D:\n\n1. Known or suspected neurofibromatosis-1 (NF-1) and\u002For RAS related gene alterations or other co-occurring driver mutations.\n2. Participant has a non-CNS solid tumor with CNS metastases.\n3. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n4. Active infection requiring systemic therapy.\n5. HIV infection with exceptions; discuss with treating physician.\n6. Use or anticipate the need for medications with known risk for QT-prolonging potential and Torsades de Pointes.\n7. History of acute or chronic cardiovascular disease or surgery, hypertension, with systolic blood pressure \\>160mm HG, history of QTc abnormalities, or clinical significantly ECG abnormalities.","10 Years",{"count":460,"type":21},254,[156],"The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with rare BRAF V600-mutated solid tumors, melanoma, thyroid, or recurrent primary CNS tumors.",[464,465,466,30],"Cancer Harboring BRAF Alterations","HGG","LGG",[468,469,470,471,472,473,474,465,466,475],"BRAF alterations","BRAF Fusions","BRAF V600E","BRAF Class 1","BRAF Class 2","High grade glioma","low grade glioma","Solid tumors","2026-06-04",{"date":478,"type":40},"2026-06-05",{"date":480,"type":40},"2023-02-21",{"date":482,"type":21},"2026-12-28",{"name":484,"class":90},"Fore Biotherapeutics",70,{"id":487,"slug":4,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":22,"phases":493,"briefSummary":494,"conditions":495,"keywords":504,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":511,"leadSponsor":512,"locationsCount":4},"100643560","NCT07631871","An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old.\n2. Subjects with locally advanced, unresectable or metastatic solid tumors who have progressed after ≥1 prior systemic therapy for advanced\u002Fmetastatic disease, or have no available optimal alternative treatments. Qualified tumor types include but are not limited to endometrial carcinoma, urothelial carcinoma, pancreatic cancer, colorectal carcinoma (CRC), head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary of the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Biliary tract malignancy, lung cancer and breast cancer are excluded. For CRC patients: documented RAS status (wild-type or mutant) and wild-type BRAF; prior treatment regimen should contain fluoropyrimidine, oxaliplatin and irinotecan unless contraindicated; anti-VEGF therapy when clinically indicated; anti-PD-L1 therapy for MSI-H\u002FdMMR tumors if clinically indicated.\n3. ECOG Performance Status 0, 1 or 2.\n4. Confirmed HER2 positivity defined as IHC 3+, or IHC 2+ with positive FISH amplification (per GC criteria).\n5. Willing and capable of providing adequate tumor specimens for central pathological re-assessment of HER2 status at institutional pathology department. Patients previously treated with HER2-ADC must provide FFPE tumor samples collected after last HER2-ADC administration. Specimens with insufficient tumor cellularity and fine-needle aspiration samples are not acceptable for HER2 testing.\n6. At least one measurable lesion at baseline per RECIST 1.1 criteria.\n7. Adequate bone marrow and organ function confirmed within 14 days prior to enrollment: Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 75,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1000\u002Fmm³; Serum albumin ≥ 2.5 g\u002FdL; PT, aPTT and INR ≤ 1.5 × ULN; AST\u002FALT ≤ 3 × ULN; ≤5 × ULN for subjects with liver metastasis; Total bilirubin ≤1.5 × ULN (no liver metastasis); ≤3 × ULN (baseline Gilbert syndrome or liver metastasis); Creatinine clearance ≥30 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n8. LVEF ≥50% evaluated via echocardiogram (ECHO) or MUGA scan within 28 days before enrollment.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions are ineligible:\n\n1. Documented spinal cord compression, leptomeningeal disease or clinically active central nervous system (CNS) metastasis.\n2. Active primary immunodeficiency, confirmed HIV infection, active HBV or HCV infection.\n3. History of non-infectious interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring steroid therapy, ongoing active ILD\u002Fnon-infectious pneumonia, or suspected ILD\u002Fnon-infectious pneumonia that cannot be ruled out by screening imaging.\n4. History of myocardial infarction, symptomatic congestive heart failure (CHF, NYHA Class II-IV), unstable angina, or any cardiovascular event (including stroke) within 6 months prior to enrollment.\n5. Pulmonary exclusion items: (a) Clinically significant underlying pulmonary disorders, including but not limited to pulmonary embolism within 3 months before screening, severe asthma, severe COPD, restrictive lung disease, recurrent pleural effusion; (b) Confirmed autoimmune, connective tissue or inflammatory diseases (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis etc.), or suspected pulmonary involvement at screening; full disease details shall be recorded in eCRF for enrolled subjects; (c) Previous total pneumonectomy.\n6. Confirmed presence of HER2 gene mutation.",{"count":492,"type":21},10,[156],"The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on Day 1 of each 2-week treatment cycle. The dosage is 20 mg\u002Fkg per cycle.",[102,30,496,497,498,499,500,501,502,503],"HER2 Positive Solid Tumor","Endometrial Neoplasm","Urothelial Carcinoma (UC)","Pancreatic Neoplasms","Colorectal Neoplasms","Head and Neck Neoplasms","Cervical Neoplasms","Ovarian Neoplasms",[496,505,506],"Zanidatamab","Basket Study","2026-06-02",{"date":509,"type":40},"2026-06-08",{"date":352,"type":21},{"date":252,"type":21},{"name":513,"class":328},"Haihua Yuan",{"id":515,"slug":4,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":534,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":540,"leadSponsor":542,"locationsCount":4},"100643697","NCT07631884","Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor","Inclusion Criteria:\n\n1. Male and female participants aged 18 years or older.\n2. Participants with locally advanced, unresectable or metastatic solid tumors who have progressed after at least one prior systemic therapy for advanced\u002Fmetastatic disease, or have no satisfactory alternative treatment options. Eligible tumor types include but are not limited to biliary tract cancer, endometrial cancer, urothelial carcinoma, pancreatic cancer, colorectal cancer, gastric cancer, non-small cell lung cancer, head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary in the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Breast cancer is excluded.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n4. Confirmed HER2 expression defined as IHC 1+, 2+ or 3+ (per GC criteria).\n5. Willing and able to provide adequate tumor specimens for central pathological re-testing of HER2 status. For participants previously treated with anti-HER2 therapy, tumor specimens obtained after the last anti-HER2 treatment are optional.\n6. At least one measurable lesion at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Adequate organ and bone marrow function within 14 days prior to enrollment, meeting the following criteria:\n\n   Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 100,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1500\u002Fmm³; Serum albumin ≥ 3.0 g\u002FdL; Prothrombin time (PT), activated partial thromboplastin time (aPTT) and International Normalized Ratio (INR) ≤ 1.5 × upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN; ≤ 5 × ULN for participants with liver metastases; Total bilirubin ≤ 1.5 × ULN for participants without liver metastases; ≤ 3 × ULN for participants with Gilbert's syndrome or liver metastases at baseline; Creatinine clearance ≥ 30 mL\u002Fmin (calculated by the Cockcroft-Gault formula)\n8. Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days prior to enrollment.\n\nExclusion Criteria:\n\nParticipants meeting any of the following conditions are ineligible for this study:\n\n1. Presence of any severe and\u002For uncontrolled diseases:\n\n   * Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL).\n   * Grade ≥ 2 myocardial ischemia, myocardial infarction, arrhythmia (QTc interval ≥ 470 ms), or Grade ≥ 2 congestive heart failure (per New York Heart Association \\[NYHA\\] classification).\n   * Active or uncontrolled severe infections (Grade ≥ 2 per NCI CTCAE) requiring systemic antibacterial, antifungal or antiviral therapy, including pulmonary tuberculosis.\n   * History of active tuberculosis.\n   * Uncontrolled ascites, pericardial effusion or pleural effusion requiring repeated drainage.\n2. Active hepatitis: Liver function not meeting the inclusion criteria. Hepatitis B: HBV DNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL.Hepatitis C: HCV RNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL. Participants with viral load below the above thresholds after nucleoside antiviral therapy are eligible. Chronic hepatitis B virus carriers with HBV DNA \\\u003C 10\\^4 IU\u002FmL must receive concurrent antiviral treatment throughout the study for enrollment.\n3. History of immunodeficiency diseases, including HIV positivity or other acquired\u002Fcongenital immunodeficiency disorders.\n4. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n5. Confirmed meningeal metastasis, spinal cord metastasis or spinal cord compression.\n6. Within 6 months prior to the first study drug administration, presence of esophageal gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive intestinal resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or long-standing chronic diarrhea.\n7. Unhealed or poorly healing wounds, or active ulcers.\n8. Toxicities from prior anti-tumor therapy have not resolved to Grade 0 or 1 per NCI CTCAE version 5.0.\n9. Received major surgery, incisional biopsy or significant traumatic injury within 28 days before study treatment initiation; or with long-standing unhealed wounds or fractures.\n10. History of severe hypersensitivity reactions to monoclonal antibodies; known allergy to the active ingredients or excipients of the study drug.",{"count":520,"type":21},15,[156],"The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants.\n\nThe main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg\u002Fkg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.",[30,524,525,526,527,528,529,530,531,498,499,500,532,533,501,502],"Neoplasms (Cancer \u002F Tumors)","Advanced Malignant Solid Neoplasm","Locally Advanced Malignant Solid Neoplasm","Unresectable Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm","HER2 Expression","Biliary Tract Neoplasms","Endometrial Neoplasms","Gastric Neoplasms","Non-Small Cell Lung Carcinoma (NSCLC)",[535,536,537],"HER2 expression","Trastuzumab Rezetecan","Advanced Solid Tumor",{"date":509,"type":40},{"date":352,"type":21},{"date":541,"type":21},"2028-12-31",{"name":513,"class":328},{"id":544,"slug":4,"hasResults":11,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":433,"enrollmentInfo":549,"targetDuration":4,"studyType":22,"phases":551,"briefSummary":552,"conditions":553,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":4},"100640733","NCT07624864","A Study to Evaluate the Safety, Tolerability, PK and Efficacy of Hemay5087 in Patients With Advanced Solid Tumors","A PHASE I CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC CHARACTERISTICS, AND PRELIMINARY ANTI-TUMOR EFFICACY OF HEMAY5087 IN PATIENTS WITH ADVANCED SOLID TUMORS","Inclusion Criteria:\n\n1. Subjects who voluntarily signed a written informed consent form before the start of the study;\n2. Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .\n3. Subjects who have a least one measurable lesion that can be evaluated by CT\u002FMRI and meets the requirement for reproducible evaluation in RECIST V1.1;\n4. At least 4 weeks or 5 half-lives (whichever is shorter) have elapsed since the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and\u002For major surgery, etc.), and the participant has recovered from toxicities caused by prior treatment to grade ≤ 1 (Common Terminology Criteria for Adverse Events \\[CTCAE\\] v6.0) \\[except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk\\];\n5. Subjects with ECOG PS score of 0-1;\n6. Subjects with expected survival more than 3 months;\n7. Participants (including their partners) have no plan for pregnancy from signing the informed consent form through 6 months after the last dose and voluntarily agree to use effective contraception;\n\nExclusion Criteria:\n\n1. Women during pregnancy or breastfeeding;\n2. Positive syphilis testing; positive hepatitis C virus (HCV) antibody with HCV-RNA \\> ULN;;\n3. Have received investigational drug treatment in other clinical oncology therapeutic trials within 4 weeks prior to enrollment;\n4. Aallergy to the active ingredient or excipients of the investigational medicinal product;\n5. Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;\n6. The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.",{"count":550,"type":21},24,[24],"An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.",[30],"2026-05-29",{"date":556,"type":40},"2026-06-03",{"date":558,"type":21},"2026-07-15",{"date":560,"type":21},"2028-06-30",{"name":562,"class":90},"Ganzhou Hemay Pharmaceutical Co., Ltd",{"id":564,"slug":4,"hasResults":11,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":579,"leadSponsor":580,"locationsCount":48},"100639843","NCT07621471","IL-15 Enhanced NK Cell Therapy for Solid Tumors","A Single-Arm Clinical Study of IL-15 Enhanced Engineered NK Cells for Refractory Relapsed\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Age 18-70 years;\n2. ECOG 0-1;\n3. histopathologically confirmed metastatic or recurrent solid tumors (breast, liver, lung, etc.);\n4. failed prior standard therapy;\n5. \\>=1 measurable lesion per RECIST 1.1;\n6. adequate bone marrow, liver, kidney, and coagulation function;\n7. recovered from prior treatment toxicities;\n8. signed informed consent.\n\nExclusion Criteria:\n\n1. Pregnancy\u002Flactation;\n2. other malignancy within 5 years (except cured localized tumors);\n3. active autoimmune disease or immunodeficiency;\n4. uncontrolled cardiovascular disease or infection;\n5. active TB;\n6. positive HBsAg\u002FHBcAb or HCV antibody (unless viral load undetectable);\n7. positive syphilis antibody;\n8. major surgery or vaccination within 28 days;\n9. prior cell therapy;\n10. severe allergy to study drugs;\n11. investigator judged unsuitable.","70 Years",{"count":571,"type":21},12,[371],"A single-arm, Phase 1 study evaluating safety, tolerability, and preliminary efficacy of IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.",[30,575],"Metastatic Cancer","2026-05-27",{"date":507,"type":40},{"date":55,"type":21},{"date":541,"type":21},{"name":581,"class":90},"Genovn Therapeutics (Suzhou) Co., Ltd.",{"id":583,"slug":4,"hasResults":11,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":593,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":612},"100630823","NCT07492680","A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)","A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion","Inclusion Criteria:\n\n* Participant must have histologically confirmed diagnosis of advanced and\u002For metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.\n* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.\n* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.\n* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.\n* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).\n* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.\n* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.\n* Participants must not have active viral HBV or HCV hepatitis.\n* Other protocol defined inclusion\u002Fexclusion criteria applies.",{"count":589,"type":21},260,[156],"This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and\u002For metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.",[30],[594,595,596,597,598,599,600,351,163,601,602,603,604],"MTAP","CDKN2A","PRMT5","MountainTAP","Targeted therapy","Brain cancer","GBM","Lung cancer PDAC","Pancreatic cancer","Navlimetostat","Navli",{"date":554,"type":40},{"date":607,"type":21},"2026-07-17",{"date":609,"type":21},"2032-05-20",{"name":611,"class":90},"Bristol-Myers Squibb",58,{"id":614,"slug":4,"hasResults":11,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":48},"100639242","NCT07591155","A Study of BL-ARC002 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 BL-ARC002 for 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 restrictions;\n3. Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);\n4. Expected survival time ≥3 months;\n5. Histopathologically and\u002For cytologically confirmed locally advanced or metastatic solid tumors that have failed standard treatment;\n6. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 2 years;\n7. Must have at least one measurable lesion as defined by RECIST v1.1;\n8. Eastern Cooperative Oncology Group performance status of 0 or 1;\n9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the required criteria;\n12. Coagulation function: International normalized ratio ≤1.5 and activated partial thromboplastin time ≤1.5 × upper limit of normal;\n13. Urine protein ≤2+ or ≤1000 mg\u002F24 hours;\n14. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test being negative, and they must not be breastfeeding; all enrolled patients (regardless of sex) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. History of serious heart disease;\n3. QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;\n4. Active autoimmune diseases and inflammatory diseases;\n5. Diagnosis of another malignancy within 5 years prior to the first dose;\n6. Hypertension inadequately controlled by two antihypertensive medications;\n7. History of ILD requiring steroid therapy, current ILD, or ≥ Grade 2 radiation pneumonitis;\n8. Active symptoms of central nervous system metastasis;\n9. History of allergy to recombinant humanized or human-mouse chimeric antibodies, or allergy to any excipient component of BL-ARC002;\n10. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n11. Cumulative anthracycline dose \\> 360 mg\u002Fm² from prior (neo)adjuvant anthracycline-based therapy;\n12. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n13. Active infection requiring systemic therapy;\n14. Participation in another clinical trial within 4 weeks prior to the first dose;\n15. Pregnancy or breastfeeding;\n16. Study participants with claustrophobia or any condition preventing them from lying still to complete examinations;\n17. Other conditions deemed by the investigator to make the participant unsuitable for this clinical trial.",{"count":204,"type":21},[24],"This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-ARC002 for injection in patients with locally advanced or metastatic solid tumors.",[30],"2026-05-26",{"date":625,"type":40},"2026-05-28",{"date":627,"type":40},"2026-05-13",{"date":629,"type":21},"2027-12",{"name":631,"class":90},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":633,"slug":4,"hasResults":11,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":637,"eligibilityCriteria":638,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":433,"enrollmentInfo":639,"targetDuration":4,"studyType":22,"phases":640,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":48},"100634345","NCT07538479","Controlled Cold Exposure Combined With PD-1\u002FPD-L1 Immunotherapy in Solid Tumors (NIVALIS)","NIVALIS Trial: A Single-Center, Prospective, Single-Arm, Open-Label Phase I Exploratory Study Evaluating the Safety, Feasibility, and Preliminary Antitumor Activity of Controlled Cold Exposure Combined With PD-1\u002FPD-L1 Immunotherapy in Patients With Solid Tumors","NIVALIS","Inclusion Criteria:\n\n* 1\\. Age 18-75 years, regardless of sex. 2. Histologically or cytologically confirmed malignant solid tumor. 3. Evaluated by the treating physician or multidisciplinary team (MDT) as currently planned to receive standard PD-1\u002FPD-L1 inhibitor monotherapy or a standard combination regimen containing PD-1\u002FPD-L1 inhibitors.\n\n  4\\. Applicable settings include neoadjuvant, perioperative, or conversion therapy, as well as unresectable locally advanced, recurrent, or metastatic disease planned for systemic therapy.\n\n  5\\. At least one evaluable lesion; for patients assessed by RECIST 1.1, at least one measurable lesion is required. Patients planned for surgery may also be included if adequate preoperative imaging and postoperative pathological assessment are available, even if RECIST measurability is not fully met.\n\n  6\\. ECOG performance status 0-1; selected patients with ECOG 2 may be enrolled at the investigator's discretion if considered able to tolerate the study procedures.\n\n  7\\. Expected survival ≥3 months. 8. Adequate major organ function, including hematologic, hepatic, renal, and electrolyte parameters acceptable for clinical study participation.\n\n  9\\. Cardiopulmonary function at rest adequate to tolerate the study procedures, without obvious abnormalities indicating intolerance to cold exposure.\n\n  10\\. Toxicities from prior antitumor therapy must have recovered to ≤ Grade 1, except for alopecia or clinically insignificant abnormalities judged by the investigator; for patients previously treated with PD-1\u002FPD-L1 inhibitors, at least 4 weeks must have elapsed before enrollment, and prior related adverse events must have recovered or stabilized sufficiently for re-exposure.\n\n  11\\. No clear contraindication to cold exposure, and deemed able to tolerate cold exposure combined with immunotherapy by the investigator.\n\n  12\\. Negative pregnancy test for women of childbearing potential; participants of reproductive potential must agree to use effective contraception during the study and for at least 3 months after the last dose.\n\n  13\\. Able to understand the study objectives, procedures, and potential risks, and willing to provide written informed consent.\n\n  14\\. For participants planned for neoadjuvant, perioperative, or conversion therapy, the investigator must confirm that study procedures will not delay planned surgery or other critical treatments.\n\nExclusion Criteria:\n\n* 1\\. Participation in another interventional clinical study or receipt of another investigational treatment within 4 weeks before study treatment initiation.\n\n  2\\. Uncontrolled active infection, including but not limited to severe bacterial, viral, or fungal infection, or active tuberculosis.\n\n  3\\. HIV infection; chronic HBV or HCV infection with uncontrolled viral replication or unacceptable liver function.\n\n  4\\. Known severe hypersensitivity to the intended PD-1\u002FPD-L1 inhibitor or its excipients.\n\n  5\\. Active autoimmune disease or a requirement for long-term moderate- to high-dose immunosuppressive therapy; physiological replacement-dose steroids may be allowed at the investigator's discretion.\n\n  6\\. Prior severe or life-threatening immune-related adverse events during PD-1\u002FPD-L1 inhibitor therapy that have not resolved or are considered high-risk for re-exposure.\n\n  7\\. Significant cardiovascular disease, including but not limited to unstable angina, severe arrhythmia, NYHA class III-IV heart failure, LVEF \\\u003C50%, or myocardial infarction, stroke, or severe thrombotic events within 6 months.\n\n  8\\. Severe chronic respiratory disease, especially conditions likely to worsen under cold stimulation, such as severe COPD or severe asthma.\n\n  9\\. Clear contraindications to cold exposure, including prior severe cold-related injury, cold urticaria, cryoglobulinemia, active Raynaud's syndrome, or other diseases judged by the investigator to preclude tolerance to a cold environment.\n\n  10\\. Uncontrolled symptomatic central nervous system metastases. 11. Severe psychiatric illness, cognitive impairment, substance abuse, or alcohol dependence that would interfere with compliance.\n\n  12\\. Pregnancy or breastfeeding. 13. Uncontrolled diabetes, severe malnutrition, marked frailty, or any other condition judged to make the participant unable to tolerate cold exposure or study procedures.\n\n  14\\. Any situation in which study participation may significantly delay standard therapy, planned surgery, or other critical treatment timing.",{"count":550,"type":21},[24],"This is a single-center, prospective, single-arm, open-label phase I exploratory study that plans to enroll 24 participants with solid malignancies. All participants will receive controlled cold exposure in addition to standard PD-1\u002FPD-L1 inhibitor monotherapy or PD-1\u002FPD-L1 inhibitor-based standard combination therapy. A 2-day cold acclimation phase will precede formal intervention, consisting of approximately 20°C exposure for 8 hours on Day -2 and approximately 18°C exposure for 10 hours on Day -1. The first combination cycle begins on Day 1 concurrently with PD-1\u002FPD-L1-based treatment, with exposure to an 18°C temperature-controlled hospital room for 12 hours per day for 7 consecutive days. If tolerated, cold exposure may be repeated in subsequent PD-1\u002FPD-L1 treatment cycles. The primary objective is to evaluate safety, tolerability, and feasibility. Secondary objectives are to explore preliminary antitumor activity and the effects on brown adipose tissue activation, peripheral immune profiling, circulating cytokines, metabolomics, gut microbiota, patient-reported outcomes, and tumor immune\u002Fmetabolic biomarkers when paired tumor tissue is available.",[30,643,644,35],"Solid Malignancies","Cold Exposure","2026-05-24",{"date":625,"type":40},{"date":648,"type":40},"2026-04-20",{"date":650,"type":21},"2029-06-30",{"name":652,"class":328},"West China Hospital",""]