[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumor":618},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,290,0,25,[9,44,71,93,111,135,155,178,201,221,245,322,341,358,383,407,432,448,468,487,514,532,556,567,586],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053849",false,"NCT06589596","An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors","A Phase 1a\u002Fb Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination With Anticancer Agents in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must sign the ICF and be capable of giving written informed consent\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70\n* Life expectancy ≥ 3 months\n* Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue\n* Able to provide tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing\n* Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose diseases have progressed or recurred after receiving standard systemic therapy or radiotherapy, or for whom standard systemic therapy is not available or tolerated, or would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard treatment in the opinion of the investigator; participants with advanced, metastatic, or unresectable solid tumors who have not received prior systemic treatment or have received one cycle of standard-of-care therapies will be enrolled in selected cohorts\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor\n* Active leptomeningeal disease or symptomatic spinal cord compression\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage\n* Any malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively\n* Significantly impaired pulmonary function\n* Clinically significant infections\n* Serologically active hepatitis B or C infection\n* Known HIV infection. Participants with treated HIV infection may be included in Phase 1b if they meet certain criteria\n* High cardiovascular risk factors\n* QTcF \\> 470 ms based on the screening triplicate 12-lead ECG records and\u002For a history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome)\n* Toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized\n* Participants who are unable to swallow or with disease\u002Fprocedure significantly affecting gastrointestinal function\n* Female participants who are pregnant or are breastfeeding\n* Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed)\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},525,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.",[26],"Advanced Solid Tumor",[28,29,30],"advanced solid tumor","BGB-58067","MTAP deficiency","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2025-01-10",{"date":39,"type":20},"2027-09-30",{"name":41,"class":42},"BeOne Medicines","INDUSTRY",96,{"id":45,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100592715","NCT06997029","A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors","A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4\u002F6 Inhibitor Pre-treated Advanced Breast Cancer","Inclusion Criteria:\n\n* Participants must be ≥ 18 years of age.\n* Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.\n* Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* For Part 2A only, participants must have CCNE1-amplified ovarian cancer\n\nExclusion Criteria:\n\n* Participants must not have an active brain metastasis.\n* Participants must not have impaired cardiac function or clinically significant cardiac disease.\n* Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.\n* Participants must not have Grade ≥ 2 peripheral neuropathy.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":51,"type":20},234,[23],"The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4\u002F6 inhibitor pre-treated advanced breast cancer.",[26,55,56],"Advanced Breast Cancer","Advanced Ovarian Cancer",[58,59,60],"cancer","oncology","solid tumor","2026-07-01",{"date":63,"type":35},"2026-07-02",{"date":65,"type":35},"2025-08-01",{"date":67,"type":20},"2028-12-14",{"name":69,"class":42},"Bristol-Myers Squibb",21,{"id":72,"slug":4,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100609380","NCT07213830","A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies","An Open-label, Phase I\u002FII First in Human, Dose Escalation, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Participants With Locally Advanced or Metastatic Solid Tumours Who Have Progressed on or After Immune Checkpoint Inhibitor Therapies","Inclusion Criteria:\n\n* Participant must be ≥18 years of age, at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Measurable disease per RECIST version 1.1 (at least one lesion that is measurable by RECIST 1.1. Tumour lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation) and documented locally advanced or metastatic disease with CT and\u002For MRI.\n* All acute, clinically significant (CS) treatment-related AEs from a prior therapy resolved to Grade 1 or lower prior to study entry. Participants with chronic toxicities such as Grade ≤2 neuropathy or alopecia can be included.\n* Have a life expectancy for disease-related mortality, as evaluated by the investigator.\n* Male and female participants: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Adequate haematologic and end organ function\n* Participant is capable of giving signed informed consent as described in the protocol.\n\nExclusion Criteria:\n\n* Have untreated or active primary brain tumour, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression.\n* Experienced severe, life-threatening immune-mediated AEs, or infusion-related reactions such as those that lead to permanent discontinuation while on treatment with prior anticancer therapy such as immune checkpoint inhibitor therapy.\n* History of known autoimmune disease\n* History of stroke or significant cerebrovascular disease, encephalitis, meningitis, organic brain disease (e,g., Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study drug.\n* History of CS cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as New York Heart Association Grade 2 or higher. Additional exclusion criteria include:\n\n  1. Left ventricular ejection fraction \\\u003C45%\n  2. QT interval corrected by Fridericia (QTcF) \\>470 ms (for women) and \\>450 ms (for men) or CS arrhythmias.\n* History of CS respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.\n* Prior organ transplantation.\n* Chronic or ongoing active infections within 4 weeks prior to Cycle1 Day1 (C1D1).\n* Presence of hepatitis B surface antigen (HBsAg) \\[or hepatitis B core antibody (HBcAb)\\] at screening or within 3 months prior to the first dose of study intervention.\n* Positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of study intervention.\n* Participants with known history of HIV infection are excluded from the study unless they meet the following criteria:\n\n  1. Stable Antiretroviral Therapy: Participants must be on a stable antiretroviral therapy regimen for at least 4 weeks prior to enrolment.\n  2. CD4+ T cell Count: Participants must have a CD4+ T cell count of at least 200 cells\u002FµL.\n  3. Viral Load: Participants must have an undetectable viral load (HIV RNA \\\u003C50 copies\u002FmL)\n  4. No Opportunistic Infections: Participants must not have had any opportunistic infections or other human immunodeficiency virus (HIV)-related illness within the past 6 months Note: HIV testing will be performed in any countries where it is mandatory per local requirements.\n* History of other malignancy within the last years.\n* Significant concurrent, uncontrolled medical condition that would put participants at unacceptable risk from study participation or preclude them from complying with study procedures per investigator including, but not limited to renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.\n* Treatment with \\>10 mg per day of prednisone (or equivalent) or other immune suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for participants who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.\n* Concurrent participation in another therapeutic treatment study.\n* Participants accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalised.\n* For French participants only: participants are under court protection, not affiliated to a social security system or protected adults.",{"count":78,"type":20},102,[23,80],"PHASE2","The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new drug, IPN01203, in adults with advanced solid tumours.\n\nAdvanced solid tumours are cancers that can occur in various organs or tissues and have spread from their original site to nearby tissues or other parts of the body.\n\nThere will be two parts to this study:\n\n* Phase Ia: This part (called dose escalation) will find the dose range that shows activity against the tumour and can be tolerated by participants by testing different increasing doses of IPN01203.\n* Phase Ib: This part (called dose optimisation) will assess the ability of the drug to prevent, slow down, or stop the growth of tumours and how the body processes and responds to the drug when given in \"low dose\" or \"high dose.\" It will also further explore the safety and tolerability.\n\nAn additional part (phase II) may be added to the study based on the results of phase Ia and phase Ib.\n\nEach part will consist of the following periods:\n\n* A screening period (up to 28 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre.\n* A treatment period where all eligible participants will receive IPN01203. Requires approximately 15 visits for the first 2 months followed by 3 visits every month from month 3 until unacceptable toxicity, disease progression, death, upon participant's withdrawal of consent, investigator decision, or study termination by the sponsor, whichever occurs first.\n\nThere will also be one visit at the end of treatment (EoT), 30 days after the last administration of the study intervention or prior to the start of new anticancer treatment, whichever is earlier. Additionally, there will be one visit (the safety follow-up visit) 90 days after the last administration of study intervention or prior to the start of new anticancer treatment, whichever is earlier.\n\nIn both parts of the study, participants will undergo blood sampling, urine collection, physical examinations and clinical evaluations. They may continue some other medications, but the details need to be recorded.\n\nEach participant will be in this study until death or withdrawal from the study. IPN01203 will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time.",[26,83],"Metastatic Solid Tumor","2026-06-30",{"date":61,"type":35},{"date":87,"type":35},"2026-02-06",{"date":89,"type":20},"2032-07-14",{"name":91,"class":42},"Ipsen",11,{"id":94,"slug":4,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100580108","NCT06833008","A Study to Assess a New Medicine Called IPN01195 When Administered Alone in Adults With Advanced Solid Tumours","An Open-label, Phase I\u002FII First-in-human, Dose Escalation and Confirmation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Anti-tumour Activity of IPN01195 as Single Agent in Adult Participants With Advanced Solid Tumours","Inclusion Criteria:\n\n* Participants must be ≥18 years of age or the country's legal age of majority if the legal age is more than 18 years at the time of signing the informed consent.\n* Participants with histologically confirmed metastatic solid tumour for whom no suitable alternative standard therapy exists.\n* Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory.\n* Part A: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for central confirmation of mutation status.\n* Part B: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for MAPK genomic testing to confirm eligibility.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1\n* Eastern Cooperative Oncology Group (ECOG)\u002Fperformance status (PS) of 0 or 1\n* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n* Gastrointestinal conditions that could impair absorption of IPN01195 (specific cases e.g. remote history of gastrointestinal surgery, may be enrolled after discussion with the medical monitor)\n* Any evidence of severe active infection or inflammatory condition.\n* Non-adequate cardiac function\n* Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant's ability to cooperate with the requirements of the study.\n* Underlying medical conditions that, in the investigator's or sponsor's opinion, will obscure the interpretation of toxicity determination or AEs.\n* Known second malignancy either progressing or requiring active treatment within the last 2 years prior to first dose of the study intervention.\n* Active brain metastases or leptomeningeal\n* Current enrolment or past participation in any other clinical studies involving an investigational study treatment within the last 28 days\n* Live vaccine(s) within 28 days prior to first dose of the study intervention or plan to receive such vaccines during the study.\n* Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents).\n* Washout period of less than 28 days prior anti-cancer therapy (including chemotherapy, targeted agents, radiotherapy). If the participant was treated with an agent having a short half-life, washout can be \\\u003C28 days but not shorter than 5 times the half-life.\n* Condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of the study intervention.\n* Non-adequate bone marrow function\n* Non-adequate renal function\n* Non-adequate hepatic function\n* Known human immunodeficiency virus (HIV) infection. HIV testing will be performed in any countries where mandatory per local requirements.\n* Known uncontrolled or untreated hepatitis infection.\n\n  * (a) Known uncontrolled hepatitis B virus (HBV) infection.\n  * (b) Known untreated current hepatitis C virus (HCV) infection.\n* Sensitivity to IPN01195 or any of its components.",{"count":100,"type":20},85,[23,80],"The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 in adults with advanced solid tumours.\n\nThe participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.",[26],{"date":61,"type":35},{"date":106,"type":35},"2025-03-14",{"date":108,"type":20},"2028-10-03",{"name":91,"class":42},13,{"id":112,"slug":4,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100498099","NCT05765851","A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1, 2-Part, Multicenter, First-In-Human Dose-Escalation and Dose-Expansion Study of DS-1103a Combination Therapy in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures\n* Adults ≥18 years of age at the time the ICF is signed (please follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old)\n* Pathologically documented HER2-expressing or HER2-mutated (activating mutation) solid tumor that is unresectable or metastatic\n* Is willing and able to provide tumor tissue\n* Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment\n* Has adequate organ and bone marrow function within 14 days before the start of study treatment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 14 days prior to the day on which bone marrow function is assessed, or at any time after this day and prior to Cycle 1 Day 1.\n* A woman of childbearing potential (WOCBP) is eligible to participate if she is not pregnant as confirmed by highly sensitive pregnancy test and agrees to adhere to a contraceptive method that is highly effective during the Treatment Period and for at least the time needed to eliminate each study drug after the last dose.\n* A male participant capable of producing sperm is eligible to participate if he agrees to adhere to the contraception methods as specified in the protocol and avoids donating sperm during the Treatment Period and for at least the time needed to eliminate each study drug.\n* Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions\n\nDose-escalation Phase:\n\n* Has progressed or was non-responsive to available therapies and for which no standard or available anticancer therapy exists\n* Has a pathologically documented HER2-expressing or HER2-mutated solid tumor\n\nDose-expansion Phase:\n\n* Has pathologically documented specific HER2 altered advanced solid tumor type\n* Has received prior therapy as specified in the protocol\n\nExclusion Criteria:\n\n* Has had prior treatment with an anti-CD47 or anti-signal regulatory protein α (SIRPα) therapy.\n* Has an inadequate treatment washout period prior to start of study treatment as specified in the protocol\n* Medical history of myocardial infarction (MI) within 6 months before study enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II to IV\n* Has a QT interval corrected with Fridericia's formula (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)\n* Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening\n* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n* Has multiple primary malignancies within 3 years. Exceptions are specified in the protocol.\n* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products or other monoclonal antibodies\n* Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals\n* Is requiring concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications during the study\n* Has received a live, attenuated vaccine (messenger ribonucleic acid \\[mRNA\\] and replication-deficient adenoviral vaccines are not considered live, attenuated vaccines) within 30 days prior to first exposure to study drug(s)\n* Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the participant's participation in the clinical study or evaluation of the clinical study results.\n* Has active or uncontrolled human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid (RNA) viral load and CD4 count.\n* Has active or uncontrolled HBV or HCV. Hepatitis B and C screening testing is required. Participants are eligible only if they meet criteria as specified in the protocol.\n* Has unresolved toxicities from previous anticancer therapy\n* Female who is pregnant, breastfeeding, or planning to become pregnant\n* Has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder\n* Any autoimmune, connective tissue or inflammatory disorders\n* Prior complete pneumonectomy\n* Any of the following within 6 months of enrollment: Cerebrovascular accident, transient ischemic attack, or other arterial thromboembolism event\n* Psychological, social, familial, or geographical factors that would prevent regular follow-up\n* Any active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy\n* Uncontrolled hypertension (resting systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg) and\u002For severe arrhythmia within 28 days before enrollment",{"count":118,"type":20},108,[23],"This study will evaluate the safety and efficacy of DS-1103a combination therapy in participants with advanced solid tumors.",[26],[26,123,124,125],"DS-1103a","CD47","SIRPa","2026-06-29",{"date":61,"type":35},{"date":129,"type":35},"2023-05-30",{"date":131,"type":20},"2030-05-15",{"name":133,"class":42},"Daiichi Sankyo",8,{"id":136,"slug":4,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100452396","NCT05170958","A Phase I\u002FII Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;\n2. 18-75 years old (including boundary value), no gender limit in the I\u002FIIa trial phase；18-80 years old (including boundary value), no gender limit in the IIb trial phase；\n3. Subject has adequate organ and bone marrow function，Conforming to laboratory test results:\n4. The expected survival time is at least 12 weeks\n5. ECOG score is 0-1\n6. Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.\n\nExclusion Criteria:\n\n1. Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;\n2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;\n3. medical history of immunodeficiency including positive HIV antibody test;\n4. Women who are pregnant or breastfeeding;\n5. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study","80 Years",{"count":143,"type":20},396,[23,80],"To evaluate the phase I\u002FII clinical study of LBL-024 in the treatment of patients with advanced malignant tumors",[26],{"date":84,"type":35},{"date":149,"type":35},"2022-01-06",{"date":151,"type":20},"2026-12",{"name":153,"class":42},"Nanjing Leads Biolabs Co.,Ltd",49,{"id":156,"slug":4,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100645357","NCT07681882","First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","A Phase 1, Multicenter, Open-label, First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","To be eligible to participate in this trial, an individual must meet all the following criteria:\n\n1. Sign and date the main ICF, prior to the start of any trial-specific procedures.\n2. Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old).\n3. Histologically documented, advanced, metastatic, or unresectable solid tumors.\n4. Relapsed or refractory disease, following at least 1 line of therapy, not amenable to standard therapy.\n5. Is willing to provide a newly obtained tumor tissue sample at screening, if not clinically contraindicated and at an acceptable risk as determined by the Investigator. If a fresh tumor biopsy is not clinically feasible or would pose unacceptable risk, an archival tumor tissue sample (obtained within 24 months of consent) must be submitted.\n6. Has measurable disease based on local CT\u002FMRI imaging as assessment by the Investigator using RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention.\n7. ECOG PS of 0 or 1 assessed no more than 28 days prior to initiation of trial intervention.\n8. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention as defined in the protocol.\n9. A WOCBP is eligible to participate if the following conditions are met:\n\n   * Participant is not pregnant as confirmed by highly sensitive pregnancy test\n   * Participant does not plan to breastfeed during the Trial Intervention Period and for at least 8 months after last dose of trial intervention.\n   * Participant agrees to adhere to a contraceptive method that is highly effective with low user dependency only and agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during the Treatment Period and for at least the time needed to eliminate the trial intervention after the last dose.\n10. A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate the trial intervention:\n\n    * Avoid donating sperm.\n    * Adhere to approved contraception method as specified in the protocol.\n\nAn individual who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Prior treatment with an anti-CD25 therapy.\n2. Treatment discontinuation history due to toxicity to a DXd-ADC agent and considered not able to tolerate DS1025a based on the discussion between the investigator and the Sponsor (for participants who have DXd-ADC treatment history).\n3. Inadequate washout period before initiation of trial intervention as specified in the protocol.\n4. Has spinal cord compression or clinically active central nervous system tumors, including metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n5. Uncontrolled or significant cardiovascular disease as specified in the protocol.\n6. Any of the following within the past 6 months prior to initiation of trial intervention: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n7. Participants with any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening.\n8. Lung-specific intercurrent clinically significant illnesses as specified in the protocol.\n9. Has clinically significant pulmonary compromise or requirement for supplemental oxygen.\n10. History of other active malignancy within 3 years prior to initiation of trial intervention, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate \\>90%) and treated with expected curative outcome\n11. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 6.0, Grade ≤1 or baseline.\n12. History of hypersensitivity to any excipients in DS1025a or any known contraindication to treatment with, including hypersensitivity to, the trial intervention.\n13. Has a known history of HLH.\n14. Has a known active infection, or reactivation of latent following infections as specified in the protocol among participants who received treatment such as antivirals, antifungals, or IV antibiotics within 14 days prior to first dose of trial intervention.\n15. Has active or uncontrolled HBV infection.\n16. Has active or uncontrolled HCV infection.\n17. Has active or uncontrolled HIV infection.\n18. Has an active, known, or suspected autoimmune disease.\n19. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\>10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.",{"count":162,"type":20},45,[23],"This clinical trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy signals of DS1025a, given as a single agent to participants with advanced, metastatic, or unresectable solid tumors.",[26,83,166],"Unresectable Solid Tumor",[26,83,166,168],"DS1025a","NOT_YET_RECRUITING","2026-06-26",{"date":63,"type":35},{"date":173,"type":20},"2026-08-03",{"date":175,"type":20},"2029-01-21",{"name":133,"class":42},3,{"id":179,"slug":4,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100494587","NCT05720117","A Study of PYX-201 in Advanced Solid Tumors","A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors","Inclusion\n\n1. Histologically or cytologically confirmed solid tumors including locally advanced\u002Fmetastatic HR+ and HER2- breast cancer (post CDK4\u002F6 inhibitor +\u002F- ET, ≤ 2 lines systemic therapy), TNBC (1-3 prior lines including post ADC topo-1 payload), HNSCC (1-2 prior lines including post PD-L1\u002FPD1 and platinum based therapy), and other solid tumor types (≤ 2 lines systemic therapy).\n2. Male or non-pregnant, non-lactating female participants age ≥18 years.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.\n4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n5. Life expectancy of \\>3 months, in the opinion of the Investigator.\n6. Corrected QTcF \\\u003C470 msec.\n7. Adequate hematologic function.\n8. Adequate hepatic function.\n9. Adequate renal function.\n10. Adequate coagulation profile.\n11. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.\n\nExclusion\n\n1. History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, noninvasive bladder cancer.\n2. Known symptomatic brain metastases.\n3. Significant cardiovascular disease within 6 months prior to start of study drug.\n4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.\n5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).\n6. Failure to recover to baseline severity or Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.\n7. Participants with NCI-CTCAE v5.0 Grade \\>1 neuropathy of any etiology.\n8. Prior solid organ or bone marrow progenitor cell transplantation.\n9. Prior high-dose chemotherapy requiring stem cell rescue.\n10. Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.\n11. Palliative radiation therapy within 14 days prior to the start of study drug.\n12. Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.\n13. History of uncontrolled diabetes mellitus.\n14. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.\n15. Participants with corneal epithelial disease, with the exception of mild punctate keratopathy\n16. Participants with the best-corrected visual acuity in the worst-seeing eye worse than 20\u002F100 (Snellen equivalent).\n17. Participants with a history of (noninfectious) pneumonitis\u002F interstitial lung disease that required steroids, has current pneumonitis\u002F interstitial lung disease, or evidence of active pneumonitis on screening chest CT scan or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.",{"count":185,"type":20},330,[23],"The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with recurrent\u002Fmetastatic (R\u002FM) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.",[189,26],"Solid Tumor",[191,192],"Recurrent\u002FMetastatic Solid Tumor","PYX-201",{"date":84,"type":35},{"date":195,"type":35},"2023-03-14",{"date":197,"type":20},"2028-06-30",{"name":199,"class":42},"Pyxis Oncology, Inc",29,{"id":202,"slug":4,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100632059","NCT07508761","IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors","A Phase I\u002FII Multicenter, Non-randomized, Open-label, Dose Escalation and Expansion Study of IPG7236 Combined With Toripalimab Treatment of Advanced Solid Tumors in Adult Patients to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity","Inclusion Criteria:\n\n1. Written informed consent must be obtained before any study procedure is performed.\n2. Men or women 18 years of age or older.\n3. Histologically or cytologically confirmed advanced or recurrent malignant solid tumors that are metastatic or unresectable. (Subjects must submit tumor tissue sections from within the past 5 years for CCR8 expression testing. For subjects without paraffin-embedded tissues, a fine-needle aspiration biopsy may be performed. Subjects who cannot provide tumor tissue sections or undergo biopsy are only eligible for inclusion during the dose escalation phase. During the dose expansion phase, CCR8 positivity must be known or tumor tissue sections must be provided with confirmed CCR8 expression.)\n4. Subjects must have failed or been intolerant to standard antitumor therapy, or lack a standard treatment regimen, or be deemed by the investigator as currently unsuitable for standard therapy.\n5. According to the RECIST 1.1 criteria, there is at least one measurable lesion.\n6. Life expectancy ≥ 3 months.\n7. Subjects must be able to swallow the oral investigational drug.\n8. The ECOG performance status score is 0 or 1.\n9. Sufficient hematologic and organ function, with the following laboratory test values:\n\n   1. Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL; platelet count ≥ 75×10⁹\u002FL; Hemoglobin ≥ 9 g\u002FdL; lymphocytes ≥ 0.8×10⁹\u002FL;\n   2. Renal: Creatinine clearance calculated by the Cockcroft-Gault method ≥ 50 mL\u002Fmin or serum creatinine ≤ 1.5× upper limit of normal (ULN);\n   3. Hepatic: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3×ULN, or ≤ 5×ULN for subjects with liver metastases; total bilirubin ≤ 1.5×ULN, or ≤ 3×ULN for subjects with Gilbert syndrome or genetically equivalent conditions;\n   4. Coagulation: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5× upper limit of normal (ULN).\n10. Patients must be willing and able to comply with all scheduled visits, treatments, laboratory tests, and other study requirements.\n11. Male and female participants of reproductive potential who engage in heterosexual sexual behavior must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence,etc.) for at least 4 months during the trial period and after the last study drug administration (refer to Appendix 13.1 of the protocol)\n\nExclusion Criteria:\n\n1. Primary malignant tumors of the central nervous system or malignant tumors associated with human immunodeficiency virus (HIV) .\n2. Previous use of CCR8-targeted therapy.\n3. Received the following treatment within the specified time frame:\n\n   1. Planned major surgery within 4 weeks prior to the first dose administration (excluding minor procedures such as vascular access placement, gastrointestinal\u002Fbiliary stent placement, or biopsy);\n   2. Immunotherapy or biological therapy administered within 28 days prior to the initial administration;\n   3. Chemotherapy \\\u003C21 days prior to the first dose, or mitomycin or nitrosoureas \\\u003C 42 days prior, or oral fluoropyrimidines \\\u003C 14 days prior;\n   4. Targeted small-molecule therapy or traditional Chinese medicine with antitumor indications administered within 14 days prior to the initial dose;\n   5. Hormone therapy or other adjuvant therapies are not permitted if initiated within 14 days prior to the first dose. Exceptions: anti-estrogen therapy, bisphosphonates, RANKL monoclonal antibodies, somatostatin analogs, and leuprorelin are permitted if initiated ≥ 14 days prior to the first dose.\n   6. Radiotherapy administered within 28 days prior to the first dose, or palliative radiotherapy within 14 days prior. Exception: Palliative radiotherapy (e.g., for analgesia) may be performed during the study drug administration period, provided that it is not permitted during the DLT observation period, any previously induced adverse events from radiotherapy have been resolved to grade \\\u003C2, and the radiotherapy was not directed at the target lesion.\n   7. Other investigational or treatments administered within 28 days prior to the first dose;\n   8. Any previous allogeneic tissue\u002Fsolid organ transplantation, including allogeneic stem cell transplantation;\n4. Previous treatment-related toxicity has not yet resolved to a level of ≤ 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0 or to the specified levels in the inclusion\u002Fexclusion criteria (except for safety risks deemed by the investigator as not significant, such as alopecia, grade 2 peripheral neuropathy, hypothyroidism or hyperthyroidism, or other endocrine disorders well-controlled by hormone replacement therapy).\n5. In combination with other active malignancies (excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder cancer with no evidence of disease after potentially curative treatment; For other patients with previous malignant tumors who have survived without disease for more than 3 years, they are also (acceptable).\n6. Immune-related adverse events (irAEs) of grade ≥ 3 or those leading to treatment discontinuation during prior immunotherapy, or grade ≥ 2 immune-mediated myocarditis, or treatment discontinuation due to allergic or infusion-related reactions.\n7. Diagnosis of primary or acquired immunodeficiency, or receipt of systemic glucocorticoids or any other form of immunosuppressive therapy within 7 days prior to the first dose. Exceptions: intraocular, intranasal, intra-articular, inhaled, or systemic glucocorticoids (prednisone dose ≤ 10 mg\u002Fday or equivalent, or doses used for adrenal replacement therapy), as well as a single dose of immunosuppressive medication for contrast agent allergy prophylaxis (if no active autoimmune disease is present).\n8. History of autoimmune disease requiring systemic therapy or active autoimmune diseases (i.e., requiring glucocorticoids or immunosuppressive agents for disease control) within 2 years prior to study initiation are eligible, provided they do not require immunosuppressive therapy for conditions such as type 1 diabetes mellitus, vitiligo, psoriasis,hypothyroidism, or hyperthyroidism.\n9. Known severe or life-threatening allergic reactions to humanized monoclonal antibodies (mAbs) or intravenous immunoglobulin (Ig) preparations; known hypersensitivity to any investigational drug, its analogues, or excipients.\n10. Untreated brain metastases, meningeal metastases, or spinal cord compression not definitively treated with surgery or radiotherapy. (Patients with brain metastases who have stabilized without symptoms after prior treatment and have not received high-dose steroid therapy are eligible for enrollment.)\n11. Uncontrolled or requiring intravenous anti-infective therapy for active bacterial, fungal, or viral infections.\n12. Active hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) and\u002For HIV:\n\n    1. Participants must be negative for hepatitis B surface antigen (HBsAg).\n    2. For HCV antibody-positive subjects, the HCV RNA quantification must be below the research center's detection limit.\n    3. HIV test must be negative at screening;\n13. Administration of live or live-attenuated vaccines within 4 weeks prior to the first dose (inactivated vaccines, viral vector vaccines, and mRNA vaccines are permitted; seasonal vaccines should be completed prior to the first dose).\n14. The serum pregnancy test is positive within 3 days before the first dose.\n15. Lactating female subjects.\n16. Pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis) requiring glucocorticoid therapy.\n17. Patients with clinically uncontrollable ascites or pleural effusion are deemed unsuitable for enrollment by the investigator.\n18. Symptomatic cardiovascular or cerebrovascular disease; accident\u002Fstroke or myocardial infarction (MI), unstable angina, congestive heart failure (NYHA class III or higher), or severe arrhythmias uncontrolled by pharmacotherapy within 6 months prior to enrollment; mean QT interval corrected for heart rate using the Fridericia formula (QTcF) ≥ 470 ms.\n19. Any medical or social condition that may expose subjects to higher risks, affect compliance, or obscure the interpretation of safety or other clinical study data",{"count":208,"type":20},52,[23,80],"Phase 1\u002F2 Study for IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors",[26],"2026-06-25",{"date":126,"type":35},{"date":215,"type":35},"2026-06-16",{"date":217,"type":20},"2029-07-30",{"name":219,"class":42},"Nanjing Immunophage Biotech Co., Ltd",1,{"id":222,"slug":4,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100446799","NCT05098132","Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers","A Phase 1\u002F2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects With Front-line Advanced NSCLC and Other Selected Indications","SYNERGY-101","Selected Inclusion Criteria:\n\n1. Phase 1: Selected advanced solid tumors\n2. Phase 2:\n\n   * Diagnosis of non-small cell lung cancer (NSCLC).\n   * Stage IV or Stage IIIB\u002FIIIC and not a candidate for definitive treatment.\n   * Non-squamous (NSQ) cell histology.\n   * No prior systemic therapy for advanced\u002Fmetastatic NSQ NSCLC.\n   * Must have a tumor that meets at least one of the following criteria on local testing:\n\n     * PD-L1 negative (TPS \\\u003C1%), OR;\n     * STK11 mutated on tumor tissue or ctDNA\n   * No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy.\n\nSelected Exclusion Criteria:\n\n2\\. Phase 2:\n\n* Prior immune checkpoint inhibitor (anti-PD\\[L\\]1 and\u002For anti-CTLA-4) treatment\n* Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components).\n* Received radiotherapy ≤ 7 days of the first dose of study treatment.\n* Known active central nervous system metastases\n* Any history of carcinomatous meningitis",{"count":229,"type":20},364,[23,80],"This is a phase 1\u002F2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative or STK11 mutated, non-squamous, non-small cell lung cancer.",[26,233,234,235],"Non Small Cell Lung Cancer","Untreated Advanced NSCLC","1st Line NSCLC","2026-06-24",{"date":126,"type":35},{"date":239,"type":35},"2022-01-25",{"date":241,"type":20},"2029-01",{"name":243,"class":42},"Synthekine",47,{"id":246,"slug":4,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":16,"minAge":251,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":21,"phases":254,"briefSummary":255,"conditions":256,"keywords":285,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":321},"100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":253,"type":20},300,[23,80],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[26,257,258,83,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284],"Advanced Malignant Neoplasm","Metastatic Cancer","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt",{"date":170,"type":35},{"date":316,"type":35},"2020-10-29",{"date":318,"type":20},"2027-12-31",{"name":320,"class":42},"PMV Pharmaceuticals, Inc",77,{"id":323,"slug":4,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":21,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":7},"100533057","NCT06220864","SNV1521 in Participants With Advanced Solid Tumors","A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Advanced or metastatic solid tumor malignancy\n* Evaluable or Measurable disease (RECIST 1.1 Criteria).\n* ECOG Performance Status 0 or 1.\n* Life expectancy \\> 3 months\n\nExclusion Criteria:\n\n* History of other malignancy within the past 2 years\n* Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia\n* Significant cardiovascular disease within 6 months\n* Significant gastrointestinal disease\n* HIV infection with a CD4+ T-cell count \\\u003C 200 cells\u002FμL and\u002For a detectable viral load\n* Liver dysfunction",{"count":329,"type":20},400,[23],"This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.",[26],"2026-06-23",{"date":212,"type":35},{"date":336,"type":35},"2024-02-23",{"date":338,"type":20},"2027-12",{"name":340,"class":42},"Synnovation Therapeutics, Inc.",{"id":342,"slug":4,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":21,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":354,"leadSponsor":356,"locationsCount":220},"100643977","NCT07669415","A Study of LM-168 Combined With Other Anti-tumor Treatments in Participants With Advanced Solid Tumors","A Phase II，Open Label,Multicenter Study to Evaluate the Efficacy,Safety,and Tolerability of LM-168 Combined With Other Anti-tumor Therapies in Participants With Advanced Solid Tumor Trials","Inclusion Criteria:\n\n* Participants who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document prior to any procedure.\n* Aged ≥18 years old, male or female when sign the Informed consent form (ICF).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.\n* Life expectancy ≥ 3 months.\n* In dose escalation stage, participants must have histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.\n* In dose expansion stage, participants must have histological or cytological confirmation of selected advanced solid tumors.\n* Pre-treatment archived tumour tissue (within 5 years) or on treatment could be provided for biomarker analysis optionally.\n* At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.\n* Participants must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.\n* Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study\n\nExclusion Criteria:\n\n* Received any other investigational product or treatment within 28 days prior to the first dose of LM-168.\n* Received anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) agents, any other immunotherapy or oncology immune-oncology (IO) drugs within 28 days prior to the first dose of LM-168; or permanently discontinued prior immunotherapy due to immune-related adverse events (irAEs). All adverse events (AEs) from previous anti-tumor treatments have not fully resolved or resolved to Grade 1 prior to screening. Requirement for additional immunosuppressants (other than low-dose corticosteroids) to control irAEs.\n* Received other anti-tumor treatments prior to the first dose of LM-168, as specified below:\n\n  1. Received limited-field palliative radiotherapy within 14 days prior to the first dose (excluding radiotherapy solely for pain control of bone metastases).\n  2. Received chemotherapy, small-molecule targeted agents (e.g., tyrosine kinase inhibitors) or hormonal therapies within 14 days prior to the first dose or within 5 half-lives of the respective agent (whichever is longer).\n  3. Received biologic therapy or immunotherapy within 28 days prior to the first dose or within 5 half-lives of the respective agent (whichever is shorter).\n  4. Received traditional Chinese medicines with anti-tumor indications within 14 days prior to the first dose.\n  5. Received nitrosoureas or mitomycin C within 42 days prior to the first dose.\n* AEs from prior anti-tumor treatments have not recovered to Grade ≤ 1 per NCI CTCAE Version 6.0. Exceptions include: toxicities assessed by the Investigator to pose no safety risks (e.g., alopecia), long-term radiation-related toxicities with Grade ≤ 2, and hypothyroidism stabilized with hormonal replacement therapy.\n* Uncontrolled tumor-related pain. Participants requiring analgesic treatment must have been on a stable analgesic dose prior to study entry.\n* Known active brain metastases or leptomeningeal metastases.\n* Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.\n* Esophageal or gastric varices requiring immediate clinical intervention, or a history of variceal bleeding; except for participants with stable conditions confirmed by endoscopic evaluation within 3 months prior to the first study drug administration.\n* History of hepatic encephalopathy, hepatorenal syndrome, or cirrhosis classified as Child-Pugh Class B or higher.\n* Tumor invasion into adjacent vital organs (e.g., aorta, heart, pericardium, superior vena cava, trachea, esophagus, etc.), or at risk of developing esophagotracheal fistula or esophagopleural fistula.\n* Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea).\n* History of Grade ≥ 3 hypersensitivity reactions to monoclonal antibody-based therapies.\n* Experienced Grade ≥ 3 irAEs during prior immunotherapy, or discontinued prior immunotherapy due to severe or life-threatening irAEs.\n* Received systemic corticosteroids (prednisone equivalent \\> 10 mg daily) or other systemic immunosuppressive agents (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of LM-168. Topical, ophthalmic, intra-articular, intranasal and inhaled corticosteroids are permitted.\n* Known history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis and glomerulonephritis (see Appendix 3 for the complete list of autoimmune diseases). Exception: participants with autoimmune hypothyroidism maintained on a stable dose of thyroid replacement hormones.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonia, interstitial lung disease or severe radiation pneumonitis; or evidence of active pneumonia on chest CT scan during the screening period.\n* Received any live vaccine within 28 days prior to the first dose.\n* Underwent major surgery or interventional procedures within 28 days prior to the first dose of LM-168 (excluding tumor biopsy, puncture and other minor procedures).\n* Severe cardiovascular and cerebrovascular diseases,\n* Uncontrolled or severe concomitant diseases, including ongoing or active infections (e.g., active COVID-19\u002FSARS-CoV-2 infection, syphilis) requiring therapeutic antibiotics and\u002For other medications. SARS-CoV-2 testing is not mandatory for study enrollment but shall comply with local clinical practice guidelines and standards.\n* History of immunodeficiency disorders, including other acquired or congenital immunodeficiencies; or history of solid organ transplantation, allogeneic bone marrow transplantation or autologous hematopoietic stem cell transplantation.\n* Human Immunodeficiency Virus (HIV) infection, or active hepatitis infection (including tuberculosis, Hepatitis B Virus \\[HBV\\] and Hepatitis C Virus \\[HCV\\] infection),\n* History of other malignancies within 5 years prior to the first study drug administration. Exceptions include cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate cancer (defined as Stage ≤ T2a, Gleason score ≤ 6, curatively treated at diagnosis with no biochemical recurrence of prostate-specific antigen \\[PSA; PSA ≤ 10 ng\u002FmL if tested\\]), carcinoma in situ of cervix or breast, and other malignancies deemed appropriate for study participation by the Investigator.\n* Females of childbearing potential with a positive pregnancy test or who are breastfeeding.\n* Psychiatric illnesses or disorders that may interfere with study compliance.\n* Any other conditions that render the participants unsuitable for study participation, as determined by the Investigator.\n\nExclusion Criteria for the Combination cohort with Docetaxel\n\n1. Prior exposure to taxane-based therapies.\n2. Received strong CYP3A4 inhibitors or strong CYP3A4 inducers within 14 days prior to the first dose (see Appendix 5).",{"count":118,"type":20},[80],"For Safety introduction phase，this study is to evaluate the safety and tolerability of LM-168 in combination with other anti-tumor treatment regimens in participants of advanced solid tumor trials, determine the maximum tolerated dose (MTD), and explore the recommended phase II dose (RP2D).\n\nFor Dose expansion phase，this study is to evaluate the preliminary antitumor activity of LM-168 in combination with other antitumor treatment regimens in participants of advanced solid tumor trials, measured by objective response rate (ORR)",[26],"2026-06-22",{"date":212,"type":35},{"date":84,"type":20},{"date":355,"type":20},"2028-12-15",{"name":357,"class":42},"LaNova Medicines Limited",{"id":359,"slug":4,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":366,"briefSummary":367,"conditions":368,"keywords":369,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":382},"100605752","NCT07166601","M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors","An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic Profile of M0324, a Bispecific (MUC-1 x CD40) Antibody as Monotherapy, in Combination With Pembrolizumab, and in Combination With Chemotherapy, in Participants With Selected Advanced Solid Tumors","TITER","Inclusion Criteria:\n\nPart 1- M0324 Monotherapy:\n\n• Participants with certain advanced\u002Fmetastatic solid tumor types known to overexpress MUC-1 and who are intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator\n\nPart 2- M0324 Combination with Pembrolizumab:\n\n• Participants with certain advanced\u002Fmetastatic tumor types known to overexpress MUC-1 and the participants in the combination treatment involving M0324 and pembrolizumab must be intolerant or refractory to standard therapy and no other further standard therapy should be judged appropriate by the Investigator. In addition, the participants must have had prior treatment with immune checkpoint inhibitor(s) (ICIs) and must have experienced documented disease progression on or after ICIs.\n\nPart 3- M0324 Combination with mFOLFIRINOX:\n\n* Participants with previously untreated metastatic pancreatic ductal adenocarcinoma, who are judged by Investigator as eligible for treatment with mFOLFIRINOX. Participants with prior Whipple surgery and\u002For adjuvant chemotherapy are not permitted\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Has a history of chronic diarrhea greater than or equal to (\\>=) Grade 2, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction\n* Participant has a history of malignancy within 3 years before the date of enrollment\n* Uncontrolled or poorly controlled arterial hypertension, uncontrolled cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart failure \\[New York Heart Association (NYHA) \\>= II\\] or a coronary revascularization procedure within 180 days of study entry\n* Life expectancy of less than 3 months\n* Other protocol defined exclusion criteria could apply",{"count":321,"type":20},[23],"The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).",[26],[370,371,298,372,373,374],"Bispecific CD40 agonistic antibody","Mucin-1 (MUC-1)","mFOLFIRINOX","pancreatic ductal adenocarcinoma (PDAC)","non-small cell lung cancer (NSCLC)",{"date":333,"type":35},{"date":377,"type":35},"2025-10-10",{"date":379,"type":20},"2029-02-23",{"name":381,"class":42},"EMD Serono Research & Development Institute, Inc.",5,{"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":21,"phases":390,"briefSummary":391,"conditions":392,"keywords":393,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":92},"100565417","NCT06641908","Anti-GD2 ADC M3554 in Advanced Solid Tumors","A Phase 1, Two-Part, Multicenter, Open-Label First in Human Study of Anti-GD2 Antibody Drug Conjugate M3554 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has progressed after at least one prior line of anthracycline-containing systemic therapy for the locally advanced\u002Fmetastatic setting.\n* Participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is residual disease after surgery and if the surgery was performed at least 4 weeks before first dose of study intervention.\n* Escalation B: participants with documented histopathological diagnosis of glioblastoma, IDH-wildtype, who have progressed after ONLY one prior line of therapy (including radiotherapy +\u002F- temozolomide, depending on the O\\^6-methylguanine-DNA methyltransferase \\[MGMT\\] status) and relapsing at least 3 months after the end of the radiotherapy treatment.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1\n* Participants with adequate hematologic, hepatic and renal function as defined in protocol\n* Other protocol defined inclusion criteria could apply\n\n  * Exclusion Criteria:\n* Participant has a history of malignancy other than STS or glioblastoma (depending on the escalation\u002Fexpansion cohort) within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm\u002Fhypertropia, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years).\n* STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression\n* Other protocol defined exclusion criteria could apply",{"count":208,"type":20},[23],"The purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype.\n\nStudy details include:\n\nStudy Duration per participant: Approximately 4 months",[26],[394,395,396,397,398,399,400],"Glioblastoma","IDH-wildtype","Soft tissue sarcomas","GD2 prevalence","targeted therapy","TOP1 inhibitor","exatecan",{"date":333,"type":35},{"date":403,"type":35},"2024-11-08",{"date":405,"type":20},"2027-04-16",{"name":381,"class":42},{"id":408,"slug":4,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":21,"phases":416,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":220},"100560442","NCT06577194","Neoadjuvant Short-Course Radiotherapy Followed by CAPOX Plus PD-1 Antibody and IL-2 in Locally Advanced Rectal Cancer","A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy Followed by Sequential Immunotherapy With CAPOX Combined With PD-1 Antibody and IL-2 for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Males and females aged between 18 and 70 years;\n* ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;\n* Tumor tissue samples obtained and histologically confirmed as rectal adenocarcinoma;\n* Adequate hematological, liver, and kidney functions: neutrophil count ≥ 1.5×10\\^9\u002FL; platelet count ≥ 75×10\\^9\u002FL; serum total bilirubin ≤ 1.5× upper limit of normal (UNL); aspartate aminotransferase ≤ 2.5× UNL; alanine aminotransferase ≤ 2.5× UNL; serum creatinine ≤ 1.5× UNL.\n\nExclusion Criteria:\n\n* Metastatic disease (Stage IV);\n* Recurrent rectal cancer;\n* Concurrent active bleeding, perforation, or other complex situations that cannot be addressed with emergency colostomy surgery alone;\n* Previous systemic anti-cancer treatment for colorectal cancer;\n* Coexistence of other non-colorectal cancer malignancies;\n* Patients with any active autoimmune diseases, or a history of needing steroids or immunosuppressive drugs;\n* Patients with interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acute pneumonia);\n* Previous treatment-induced any grade 2 or above toxicity reaction (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5 classification) that has not subsided (excluding anemia, hair loss, and skin pigmentation);\n* Previous treatment with anti-programmed death receptor-1 (PD-1) or its ligand (PD-L1) antibodies, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies;\n* Pregnant or breastfeeding women;\n* Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);\n* Known or suspected allergy history to any drugs used in the trial.","70 Years",{"count":415,"type":20},35,[80],"A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy Followed by Sequential Immunotherapy with CAPOX Combined with PD-1 antibody and IL-2 for Locally Advanced Rectal Cancer",[419,26],"Rectal Cancer",[421,422,423],"Immunotherapy","Short-course radiotherapy","IL-2",{"date":236,"type":35},{"date":426,"type":35},"2024-10-05",{"date":428,"type":20},"2028-10-31",{"name":430,"class":431},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"id":433,"slug":4,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":21,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":446,"locationsCount":134},"100543168","NCT06352359","Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors","Inclusion Criteria:\n\n* Must have ECOG score ≤ 1. The body weight should be ≥40 kg.\n* A histological or cytological diagnosis of solid tumors and metastatic disease or locally advanced disease.\n* Must have measurable target lesion according to RECIST V1.1.\n* Adequate organ function as determined by laboratory tests.\n* Voluntary agreement to participate as evidenced by written informed consent.\n* Female patient: negative pregnancy test and agreement on contraceptive methods.\n* Male patient: agreement on contraceptive methods.\n* Agree to give archival or other diagnostic tissue recut slides or an optional new tumor biopsy.\n\nExclusion Criteria:\n\n* Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled endocrine immune-related AEs are considered stable and eligible for enrollment.\n* The washout period for cancer therapeutic drugs should be 5 half-life or 21 days for chemotherapy, whichever is shorter; or 28 days for monoclonal antibody therapy. Palliative radiotherapy for painful metastases or metastases in potentially sensitive locations (e.g., epidural space) ≥ 7 days prior to the first dose of study drug. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, blood transfusion and therapy for non-cancer conditions are allowed.\n* Patients who are currently enrolled in any other clinical trial testing an investigational agent or device, or with concurrent anticancer treatment (except palliative bone-directed radiotherapy), immune therapy, or cytokine therapy or anticipated to require another antineoplastic therapy during the study.\n* Patients who are on chronic systemic steroid therapy at doses higher than 10 mg\u002Fday prednisone or equivalent within 7 days before first treatment.\n* Patients who have active brain metastases or leptomeningeal metastases. Patients who have active brain metastases or leptomeningeal metastases. Patients are eligible if brain metastases are adequately treated, and patients are asymptomatic or neurologically stable (except for residual signs or symptoms related to the central nervous system (CNS) treatment). Note: Patients with previously treated brain metastases may participate provided they are radiologically stable (i.e. no evidence of progression for ≥4 weeks by repeat imaging performed during study screening), clinically stable, and not requiring steroid treatment within 14 days before the first dose of study treatment.\n* Patient with a different cancer other than the one treated under this protocol, which requires systemic treatments within 24 months prior to C1D1.\n* Patient has history of grade ≥3 allergic or hypersensitivity to IV infusion medications, or severe allergic reactions to food, pollen, oral medications, or atopic dermatitis or asthmatic episodes that required hospitalization.\n* Within past 6 months with history of significant cardiovascular acute myocardial infarction, acute coronary syndrome, ischemic or hemorrhagic stroke, revascularization procedures, acute pulmonary embolism or any disorders resulted in LVEF \\\u003C 40% at the time of screening or colitis, small bowel obstruction, hepatitis or pancreatitis adrenal insufficiency, or severe immunotherapy related AE (irAE≥ grade 3).\n* Patients who have acute infections which require systemic treatments within 14 days prior to C1D1.\n* Patients who, in the opinion of the treating Investigator, have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make study participation not in the best interest of the patient, in the opinion of the treating Investigator. Investigators should discuss the case with the Sponsor and\u002For study leaders.\n* Patients with known psychiatric or substance abuse disorders may interfere with cooperation with the requirements of the trial.\n* Patients who are pregnant or breastfeeding or plan pregnancy or fathering the child during the study or within 6 months after the last dosing of study drug",{"count":438,"type":20},72,[23],"This is a Phase I\u002FII open label study of intravenous (IV) infusion of ONC-841 as a single agent or in combination in patients with advanced\u002Fmetastatic solid tumors. The study will evaluate seven dose levels of ONC-841. The Phase 1 part is dose escalation with 7 dose levels of ONC-841 and the dose expansion in the last dose level. The Phase 2 part will test the combination of ONC-841 with SOC in GBM and in CRC.",[26],{"date":212,"type":35},{"date":444,"type":35},"2024-08-23",{"date":39,"type":20},{"name":447,"class":42},"OncoC4, Inc.",{"id":449,"slug":4,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":16,"minAge":251,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":21,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":467},"100428178","NCT04855656","Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors","Phase 1\u002F1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors","MYTHIC","Inclusion Criteria:\n\n* Male or female and ≥12 years-of-age at the time of informed consent.\n* Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients \\>16 years of age.\n* Locally advanced or metastatic resistant or refractory solid tumors.\n* Patients \\\u003C18 years of age must weigh at least 40 kg.\n* Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible\n* Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker.\n* CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH\n* FBXW7 deleterious mutations identified by either a tumor or plasma NGS test\n* PPP2R1A deleterious mutations identified by either a tumor or plasma NGS test\n* Measurable disease as per RECIST v1.1. For certain modules, patients with prostate cancer or ovarian cancer that have non-measurable disease but have elevated tumor markers (PSA or CA-125, respectively) can also be eligible\n* Ability to swallow and retain oral medications.\n* Acceptable hematologic and organ function at screening.\n* Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.\n* Resolution of all toxicities of prior therapy or surgical procedures.\n* Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment.\n\nExclusion Criteria:\n\n* Chemotherapy or small molecule antineoplastic agent given within 21 days or \\\u003C5 half-lives, whichever is shorter, prior to first dose of study drug.\n* History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.\n* Patients who are pregnant or breastfeeding.\n* Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.\n* Major surgery within 4 weeks prior to first dose of lunresertib.\n* Uncontrolled, symptomatic brain metastases.\n* Uncontrolled hypertension.\n* Certain prior anti-cancer therapy\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\u002For follow-up procedures outlined in the protocol.",{"count":456,"type":20},464,[23],"The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.",[26],{"date":333,"type":35},{"date":462,"type":35},"2021-04-30",{"date":464,"type":20},"2028-06",{"name":466,"class":42},"Debiopharm International SA",22,{"id":469,"slug":4,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":21,"phases":476,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":4},"100644002","NCT07667842","Study of D3L-002 in Subjects With Advanced Solid Tumors","A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-002 (an Anti-TIGIT\u002FAnti-PVRIG Bispecific Antibody) Monotherapy in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Ability to provide written informed consent and comply with study procedures\n2. Age ≥18 years\n3. Histologically confirmed metastatic or locally advanced incurable solid tumor that has progressed after ≥1 line of therapy or has no available standard treatment\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n5. Adequate organ function (hematologic, hepatic, renal)\n6. Life expectancy ≥12 weeks\n7. Willingness to provide tumor tissue (if available) and blood samples\n8. Agreement to use effective contraception\n9. Negative pregnancy test for participants of childbearing potential\n\nExclusion Criteria:\n\n1. Prior anti-TIGIT or anti-PVRIG therapy\n2. Recent anticancer therapy without adequate washout\n3. Active or uncontrolled illness\n4. Interstitial lung disease\u002Fpneumonitis\n5. Active Central Nervous System (CNS) disease\n6. Uncontrolled effusions\n7. Unresolved ≥Grade 2 toxicities\n8. Severe prior immunotherapy-related toxicity\n9. Active autoimmune disease\n10. Active infection\n11. Active hepatitis B\u002FC or HIV\n12. Recent malignancy (exceptions apply)\n13. Significant cardiovascular disease\n14. Immunosuppressive therapy within 14 days\n15. Live vaccine within 30 days\n16. Pregnancy or breastfeeding\n17. Hypersensitivity to study drug\n18. Investigator-determined unsuitability",{"count":475,"type":20},24,[23],"This is a first-in-human, multicenter, open-label, single-arm, dose-escalation Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of D3L-002 monotherapy in subjects with advanced solid tumors. D3L-002 will be administered as an intravenous infusion every 3 weeks (Q3W) in 21-day cycles. Approximately 24 subjects will be enrolled. Dose escalation will follow a Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).",[26],"2026-06-21",{"date":212,"type":35},{"date":482,"type":20},"2026-07-18",{"date":484,"type":20},"2028-02-12",{"name":486,"class":42},"D3 Bio (Wuxi) Co., Ltd",{"id":488,"slug":4,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":21,"phases":495,"briefSummary":496,"conditions":497,"keywords":499,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":92},"100589253","NCT06952010","A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors","A Phase 1 Dose Escalation and Expansion Study of XB628 as a Single Agent and in Combination With Zanzalintinib in Participants With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Minimum life expectancy of ≥ 12 weeks.\n* Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed.\n* Adequate organ and marrow function.\n* Not amenable to curative treatment with surgery or radiation.\n* Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting.\n* Acceptable alternative therapy was received, refused, intolerable, or no longer effective.\n* Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements.\n\nKey Exclusion Criteria\n\n* Primary brain tumors or known active brain metastases.\n* Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment.\n* Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy.\n* Received prior therapy targeting NK cells (eg, monalizumab).\n* A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":494,"type":20},303,[23],"This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and\u002For recommended dosage(s) for expansion (RDE\\[s\\]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.",[189,26,83,498],"Immune Sensitive Tumor",[500,501,502,503,504,302,505],"XB628","Solid tumor","Advanced solid tumor","Metastatic solid tumor","Immune sensitive tumor","Zanzalintinib","2026-06-19",{"date":236,"type":35},{"date":509,"type":35},"2025-05-01",{"date":511,"type":20},"2027-11-30",{"name":513,"class":42},"Exelixis",{"id":515,"slug":4,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":21,"phases":522,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":529,"leadSponsor":531,"locationsCount":4},"100641642","NCT07659379","Gotistobart Long Term Extension (LTE) Study","Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in Gotistobart Trials","Inclusion Criteria:\n\n1. Age ≥ 18 yrs old patients who provide written informed consent for the study.\n2. Patients must have a confirmed diagnosis of advanced unresectable or metastatic solid tumors treated on the parent gotistobart trials that Sponsor designated as PRESERVE-100 transition-ready.\n3. Patients are currently enrolled\u002Frandomized and received gotistobart or gotistobart based combination therapy. Patients could be in active treatment or in survival follow up in parent trials.\n\nExclusion Criteria:\n\n1. Meet any of the study treatment discontinuation criteria specified in the parent study at the time of roll-over in this extension study.\n2. Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient.\n3. Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this extension study.\n4. Permanent discontinuation of gotistobart or combination therapy for any reason during the parent study, or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable). Exception: Participants who permanently discontinued gotistobart from parent studies remain eligible for enrollment in this study if the parent study permitted continued treatment with the combination agent(s) following discontinuation of gotistobart.\n5. Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study.\n6. Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications.\n7. Concurrent participation in any therapeutic clinical trial (other than the parent study).\n8. Pregnant, lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment in the parent trial.",{"count":521,"type":20},20,[523],"PHASE3","This LTE study will examine the long-term overall survival and safety of gotistobart in patients with advanced solid tumors.",[26],"2026-06-18",{"date":333,"type":35},{"date":61,"type":20},{"date":530,"type":20},"2037-01-01",{"name":447,"class":42},{"id":533,"slug":4,"hasResults":11,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":21,"phases":540,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":555},"100564162","NCT06625593","A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid Tumors","A Phase 1a\u002Fb, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced or metastatic solid tumors.\n2. Life expectancy of ≥ 3 months.\n3. Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgment. Combo Dose Confirmation, Combo Safety Expansion, and Dose Expansion: Participants who have received at least 1 or 2 prior lines of systemic therapy, which included a fluoropyrimidine and\u002For a platinum in the advanced or metastatic setting\n4. Tumors with FGFR2b expression\u002F or FGFR2 gene amplification. Participants must provide agreement for collection of archival tissue or recently obtained fresh tumor biopsy for central evaluation of FGFR2b expression levels and other biomarker assessments.\n5. ≥ 1 measurable lesion per RECIST v1.1.\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n7. Adequate organ function as determined per protocol.\n\nExclusion Criteria:\n\n1. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.\n2. Active or chronic corneal disorder, history of corneal transplantation, corneal keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.\n3. Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n4. Systemic antitumor therapy (including targeted therapy and immunotherapy ≤ 14 days, ≤ 28 days for immuno- oncological antibody, ≤ 14 days or 5 half-lives \\[whichever is shorter\\] for chemotherapy, ADCs, or investigational therapy) before first dose of study drug(s).\n5. Toxicities due to prior therapy that have not recovered.\n6. Any malignancy ≤ 2 years before first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively.\n7. History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygen saturation at rest \\\u003C 92%, or requirement for supplemental oxygen at baseline.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":539,"type":20},168,[23],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with advanced solid tumors. The study will be conducted in two phases: Phase 1a (Monotherapy Dose Escalation, and Safety Expansion; Combination Dose Confirmation and Safety Expansion) and Phase 1b (Dose Expansion).",[26],[544,26,545,546,547,548],"BG-C137","First-in-human","FGFR2b","ADC","Fibroblast growth factor receptor 2b",{"date":351,"type":35},{"date":551,"type":35},"2024-12-09",{"date":553,"type":20},"2026-12-31",{"name":41,"class":42},53,{"id":557,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":21,"phases":559,"briefSummary":24,"conditions":560,"keywords":561,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":564,"leadSponsor":565,"locationsCount":566},"100561394",{"count":19,"type":20},[23],[26],[28,29,30],{"date":351,"type":35},{"date":37,"type":35},{"date":39,"type":20},{"name":41,"class":42},92,{"id":568,"slug":4,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":21,"phases":575,"briefSummary":576,"conditions":577,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":585},"100491886","NCT05684965","XTX301 in Patients With Advanced Solid Tumors","A First-in-Human, Multicenter, Phase 1\u002F2, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n• Disease Criteria: Part 1A - Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit, or standard therapy is not available.\n\nPart 1B- Any histologically or cytologically confirmed solid tumor malignancy among the tumor types outlined below, that is locally advanced or metastatic and has failed standard therapy, standard therapy does not confer survival benefit, or standard therapy is not available. Patients with the following tumor types are eligible for Part 1B: melanoma, NSCLC, HNSCC, TNBC, cervical cancer, microsatellite instability high\u002Fmismatch repair deficient (MSI-H\u002FdMMR) colorectal cancer, or MSI-H\u002FdMMR endometrial cancer. Note: Based on evolving internal and external data, the Sponsor may decide to open a \"backfill cohort\" in Part 1B for patients with any of the following solid tumors: prostate cancer, ovarian cancer, pancreatic cancer, microsatellite stable colorectal cancer, T-cell lymphoma.\n\nPhase 2 - All patients must have measurable disease at baseline per RECIST 1.1, except patients with CPRC\u002FAPMR-PC. Additional disease-specific criteria per cohort are as follows:\n\ni. Cohort 2A: head and neck squamous cell carcinoma (HNSCC). Must have histologically or cytologically confirmed locally recurrent or metastatic HNSCC previously treated with 1 to 2 lines of therapy (therapy given in the curative setting or radiotherapy alone would not be counted as a line of therapy). Unless contraindicated, prior therapy must have included PD-1\u002FPD-L1 inhibitor and\u002For platinum-based chemotherapy per local and institutional standard of care. Patients who received prior PD-1\u002FPD-L1 inhibitor must have derived clinical benefit, i.e. either achieved a partial response (PR) or CR or have remained stable on PD-1\u002FPD-L1 therapy (alone or in combination) without progression for at least 6 months. Patients must have a known human papillomavirus (HPV) status (either HPV-positive or HPV-negative). Patients with known or suspected invasion or encasement of major vessel or with active or imminent airway obstruction are excluded.\n\nii. Cohort 2B: melanoma. Must have unresectable or metastatic melanoma previously treated with 1 to 2 lines of therapy in the recurrent or metastatic setting. Unless contraindicated, prior therapy must have included a PD-1\u002FPD-L1 inhibitor alone or in combination. Patients with known BRAF V600-activating mutation must have previously received targeted therapy per local and institutional standard of care. Note: patients with uveal melanoma are excluded.\n\niii. Cohort 2C: non-small cell lung cancer (NSCLC). Must have histologically confirmed locally advanced or metastatic NSCLC previously treated with 1 to 2 lines of therapy. Unless contraindicated, prior therapy must have included a PD1\u002FPD-L1 inhibitor and a platinum-based regimen, given either concurrently or separately per local and institutional standard of care. Patients with known genomic alteration for which a targeted therapy is approved (e.g. ROS1 fusion, NTRK fusion, BRAF V600E mutation, EGFR mutation, or ALK fusion) must have been previously treated with relevant targeted therapy per local and institutional standard of care.\n\niv. Cohort 2D: ovarian cancer. Must have histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with current platinum-resistant disease per investigator's assessment (e.g. patient is not eligible for further platinum-containing treatment). Patients must have previously experienced a response lasting at least 180 days to first-line platinum-based therapy. Patients who have been unable to tolerate platinum therapy are also eligible. Unless contraindicated, patients with known BRCA mutation must have received a poly(ADP-ribose) polymerase (PARP) inhibitor.\n\nv. Cohort 2E: castrate-resistant prostate cancer (CRPC)\u002Fandrogen pathway modulation-resistant prostate cancer (APMR-PC). Histopathologically or cytopathologically confirmed adenocarcinoma without neuroendocrine differentiation or small cell features. Must have metastatic disease either on bone scan and\u002For in soft tissue by CT or MRI. Patients without measurable extra-skeletal lesions must have prostate-specific antigen (PSA) levels ≥ 2 ng\u002FmL at screening. Must have been previously treated with an androgen receptor pathway inhibitor (e.g. abiraterone, enzalutamide, darolutamide, or apalutamide) and\u002For chemotherapy per local and institutional standard of care. Baseline total testosterone must be ≤ 50 ng\u002FdL (≤ 2.0 nM), and surgical or ongoing medical castration must be maintained throughout the duration of the study. Patients receiving anti-resorptive agent (e.g. bisphosphonate, denosumab) therapy must have been on stable regimen prior to study entry.\n\nvi. Cohort 2F: triple-negative breast cancer (TNBC). Must have metastatic TNBC with disease relapse after 2 to 4 previous lines of therapy per local and institutional standard of care. Neoadjuvant and\u002For adjuvant chemotherapy will count as 1 prior line of therapy only if recurrence during or within 6 months of completing adjuvant systemic therapy. Unless contraindicated, patients with known actionable mutations (e.g. BRCA1 or BRCA2) must have received prior therapy with the corresponding targeted agent per local and institutional standard of care\n\n* ECOG performance status of 0-2 for Phase 1\n* ECOG performance status of 0 or 1 for Phase 2\n* Adequate organ function\n* Tumor tissue samples: Part 1B: patients must have lesions amenable to biopsy and be willing and able to provide fresh tumor biopsies before and after initiation of treatment\n* Patients with recent major surgery must have adequately recovered with no ongoing complications from the surgery before receiving study drug\n\nExclusion Criteria:\n\n* Prior treatment with IL-12 therapy (any form, e.g. recombinant human, prodrug, intratumoral, etc.)\n* Known liver metastasis based on imaging\n* Possible area of ongoing necrosis (non-disease-related), such as active ulcer, nonhealing wound, or intercurrent bone fracture\n* Active primary central nervous system (CNS) malignancy, CNS metastases, and\u002For carcinomatous meningitis\n* Active autoimmune disease\n* History of Grade ≥ 3 immune-related adverse events associated with prior immunotherapy unless these were adequately resolved with therapy within 14 days\n* A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of study drug\n* Active hepatitis B or active hepatitis C infection\n* Prior treatment with gene therapy, organ transplant, or hematopoietic stem-cell transplant\n* Known malignancy (other than disease under study) that is progressing or has required active treatment within the past 3 years",{"count":574,"type":20},358,[23,80],"This is a first-in-human, multicenter, Phase 1\u002F2, open-label study designed to evaluate the safety and tolerability of XTX301 as monotherapy in patients with advanced solid tumors.",[26],{"date":333,"type":35},{"date":580,"type":35},"2023-05-11",{"date":582,"type":20},"2028-09",{"name":584,"class":42},"Xilio Development, Inc.",12,{"id":587,"slug":4,"hasResults":11,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":21,"phases":594,"briefSummary":595,"conditions":596,"keywords":608,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":220},"100644129","NCT07664397","Imaging Study of [89Zr]DFO-YS5 for Cancer Detection","A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies","Inclusion Criteria:\n\n1. Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.\n2. At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)\u002FCT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass.\n3. Clinically able to undergo PET-CT imaging or PET-MRI.\n4. Age ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).\n6. Adequate organ function as defined below:\n\n   * Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).\n   * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)): ≤ 3 x ULN.\n   * Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)): ≤ 3 x ULN.\n   * Estimated creatinine clearance: ≥ 60 mL\u002Fmin, calculated using the Cockcroft-Gault equation.\n7. Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries). The result of the urine or serum pregnancy test must be negative in order to initiate the \\[89Zr\\]DFO-YS5 administration. If a urine pregnancy test is positive or equivocal, a confirmatory a serum pregnancy test is required. The individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5.\n8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) or PET-MRI (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT or PET-MRI.\n2. Individuals who are pregnant or breastfeeding\u002Fchest-feeding. Pregnant and breastfeeding\u002Fchest-feeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn\u002Fnursing child secondary to treatment of the study participant with \\[89Zr\\]DFO-YS5. Females of childbearing potential must have a negative pregnancy test before administration of \\[89Zr\\]DFO-YS5, as outlined in inclusion criterion #7. Breastfeeding\u002Fchest-feeding should be discontinued before administration of \\[89Zr\\]DFO-YS5.\n3. Individuals who do not agree to follow the below contraception requirements:\n\n   Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, Intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of \\[89Zr\\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n4. Hypersensitivity to \\[89Zr\\]DFO-YS5 or any of its excipients.\n5. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.",{"count":593,"type":20},40,[23],"This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\\[89Zr\\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.",[597,598,599,600,601,602,26,603,604,605,606,607],"Bladder Cancer","Nerve Sheath Tumor","Nerve Sheath Tumors","Solid Tumor Malignancies","Solid Tumor Cancer","Solid Tumor Neoplasms","Bladder Neoplasm","Nerve Sheath Neoplasms","Nerve Sheath Tumor, Nos","Solid Tumor, Adult","Solid Carcinoma",[609],"Imaging Study","2026-06-17",{"date":236,"type":35},{"date":613,"type":20},"2026-08-01",{"date":615,"type":20},"2029-09-30",{"name":617,"class":431},"Robert Flavell, MD, PhD",""]