[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumors":621},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,246,0,25,[9,40,61,87,120,141,167,198,218,240,261,287,309,359,378,402,424,448,466,486,508,530,553,575,594],{"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":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100053941",false,"NCT07700160","First-in-Human Trial of VBC108 in Participants With Advanced Malignant Solid Tumors","Phase 1\u002F2a Open-label Clinical Trial Evaluating VBC108, a CLDN18.2 and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.\n2. Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor .\n3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.\n4. Male or female adults (defined as ≥ 18 years of age).\n5. ECOG performance status 0-1.\n6. Life expectancy greater than 12 weeks.\n7. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.\n8. Adequate organ and bone marrow function.\n9. Participants must meet the minimum washout period requirements before the first dose of investigational drug.\n\nExclusion Criteria:\n\n1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.\n2. Known or suspected brain metastases, or spinal cord compression.\n3. Prior treatment with an ADC targeting CLDN18.2x CDH17 bispecific ADC.\n4. Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.\n5. Prior treatment with CLDN18.2 targeting CAR-T.","ALL","18 Years",{"count":19,"type":20},230,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a multicenter, open-label, multiple-dose, FIH Phase 1\u002F2a trial. The Phase 1 portion uses Bayesian optimal interval (BOIN) design to escalate and determine the MTD and\u002For RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC108.",[27],"Advanced Solid Tumors","NOT_YET_RECRUITING","2026-07-07",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":31,"type":20},{"date":35,"type":20},"2029-09-17",{"name":37,"class":38},"VelaVigo Bio Inc","INDUSTRY",12,{"id":41,"slug":4,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":53,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":60},"100053709","NCT07699757","HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion","Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HSK41959 Tablets in Combination With Standard Therapy in Patients With MTAP Deletion Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Adult participants aged 18 years or older.\n2. ECOG performance status of 0 to 1.\n3. Life expectancy of at least 3 months.\n4. Histologically or cytologically confirmed advanced malignant tumor with MTAP deficiency identified by a validated assay.\n5. At least one measurable lesion according to RECIST version 1.1.\n6. For NSCLC cohorts: advanced or metastatic NSCLC meeting protocol-specified disease characteristics and prior treatment requirements.\n7. For PDAC cohorts: advanced or metastatic PDAC meeting protocol-specified disease characteristics and prior treatment requirements.\n8. Adequate bone marrow, hepatic, renal, and coagulation function.\n9. Willingness to provide tumor tissue and\u002For undergo protocol-required biomarker testing, if applicable.\n\nExclusion Criteria:\n\n1. Prior exposure to agents targeting the MAT2A or PRMT5 pathway.\n2. Prior antitumor therapy or unresolved toxicities not meeting protocol-defined washout\u002Frecovery requirements.\n3. Known actionable driver alterations or prior therapies excluded by the protocol for specific NSCLC cohorts (for example EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, KRAS G12C, HER2, as applicable).\n4. Significant gastrointestinal disorders that may affect drug absorption.\n5. Clinically significant cardiovascular disease, including clinically relevant QTc prolongation, reduced left ventricular ejection fraction, or severe heart failure.\n6. Uncontrolled metabolic disease, uncontrolled hypertension, or active infection.\n7. Known HIV infection, active hepatitis B with significant viral replication, or active hepatitis C infection.\n8. Use of prohibited concomitant medications, including strong inhibitors or inducers of CYP3A4, P-gp, BCRP, or other protocol-specified transporters\u002Fenzymes within the required washout period.\n9. Other serious medical or psychiatric conditions that, in the investigator's judgment, would make study participation inappropriate.",{"count":47,"type":20},258,[23],"This is a Phase Ib, open-label, multicenter study of HSK41959 tablets in combination with standard therapy in patients with MTAP-deficient advanced solid tumors. The study consists of dose-escalation and dose-expansion parts and is intended to evaluate the safety, tolerability, dose-limiting toxicity, maximum tolerated dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HSK41959 tablets when used together with standard therapy.",[51,52,27],"Non-Small Cell Lung Cancer","Pancreatic Ductal Adenocarcinoma (mPDAC)",{"date":31,"type":32},{"date":55,"type":20},"2026-07",{"date":57,"type":20},"2029-11",{"name":59,"class":38},"Haisco Pharmaceutical Group Co., Ltd.",1,{"id":62,"slug":4,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":21,"phases":69,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100572244","NCT06730750","A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors","A Phase 1\u002F2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors","Inclusion Criteria:\n\n* Documented histologically or cytologically confirmed, advanced, unresectable\u002Fmetastatic solid tumor measurable by RECIST v1.1.\n* CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:\n\n  i) Locally advanced\u002Fmetastatic, recurrent, or unresectable CRC with adenocarcinoma histology and whose disease has progressed after systemic cancer therapy in the metastatic or adjuvant setting including 5-FU, irinotecan, and\u002For oxaliplatin (if available and not contraindicated).\n* NSCLC: Part 2A-NSCLC\u002FGC, 2L+ NSCLC:\n\n  i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.\n\nii) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.\n\n\\- GC: Part 2A-NSCLC\u002FGC, 2L+ GC: i) Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy).\n\nii) ECOG performance status of 0 or 1.\n\nExclusion Criteria:\n\n* History of anaphylactic reactions to irinotecan and\u002For bevacizumab.\n* Previously received therapy targeting CEACAM5.\n* Grade ≥3 ILD\u002Fpneumonitis.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":68,"type":20},360,[23,24],"This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.",[27],[73,74,75],"Colorectal Cancer (CRC)","Non-small Cell Lung cancer (NSCLC)","Gastric Cancer (GC)","RECRUITING","2026-07-01",{"date":79,"type":32},"2026-07-02",{"date":81,"type":32},"2025-02-12",{"date":83,"type":20},"2029-12-09",{"name":85,"class":38},"Bristol-Myers Squibb",6,{"id":88,"slug":4,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":105,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"100379579","NCT04222413","Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","* INCLUSION CRITERIA:\n* Adult (\\>= 18 years) subjects with:\n\n  * histologically or cytologically confirmed solid tumors (Phase IA).\n\nOR\n\n--histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)\n\nOR\n\n* Pediatric (\\>=12 and \\\u003C 18 years) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell\u002Fsclerosing and pleomorphic subtypes of RMS (Phase IB).\n* Subjects must have disease that:\n\n  * is not amenable to potentially curative resection,\n  * spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor\n  * has site measurable per RECIST 1.1\n  * progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)\n  * have no standard therapy option available (Phase IB2)\n* Patients must have recovered from any acute toxicity related to prior therapy or surgery or disease to a grade 1 or less.\n* Performance status\n\n  --Karnofsky \\>= 70% (for patients \\>= 16 years old), Lansky \\>= 70% (for patients \\\u003C16 years old)\n* Adequate hematological function defined by:\n\n  * absolute neutrophil count (ANC) \\>= 1.0 x 10(9)\u002FL,\n  * transfusion-independent platelet count \\>= 100 x 10(9)\u002FL,\n  * Hgb \\>= 9 g\u002F dL (patients who have received \\\u003C= 2 PRBC transfusions within 48 hours are eligible)\n* Adequate coagulation as defined by:\n\n  --INR\\\u003C1.5 (or \\\u003C 3.0 if subjects are currently taking anticoagulated medications) Note: increase of the upper limit of INR is restricted only to subjects who are receiving anticoagulation for medical reasons (DVT\u002FPE prophylaxis, treatment for a thromboembolic event) and have increased INR because of these medications. Patients who have an elevated INR due to compromised liver function or any other medical conditions remain excluded\n* Adequate hepatic function defined by:\n\n  * a total bilirubin level \\\u003C= 1.5 x ULN, (total bilirubin \\\u003C= 2.0 x ULN in case of prior diagnosis of Gilbert syndrome)\n  * an AST level \\\u003C= 3xULN\n  * an ALT level \\\u003C= 3 xULN\n* Adequate renal function defined by:\n\n  * Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\n\n    ---\\\u003C 1.5x institution upper limit of normal OR\n\n    ---\\>= 45 mL\u002Fmin\u002F1.73 m\\^2 for participant with creatinine levels \\>= 1.5 X institutional ULN\n  * Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n* The effects of the study treatment on the developing human fetus are unknown; thus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior\n\nto study entry, for the duration of study therapy and up to 120 days after the last dose of the study drug.\n\n* Nursing participants must be willing to discontinue nursing at the time of the study treatment initiation.\n* Weight \\>= 35 kg.\n* Ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n* Subjects must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies (Cohort IB1 only).\n* Ability to swallow oral capsules.\n\nEXCLUSION CRITERIA:\n\n* Anticancer treatment within designated period before treatment initiation including:\n\n  * minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests after ureteral stenting return to normal, within 5 days after biliary or ureteral stenting;\n  * major surgical procedure or curative radiation treatment within 28 days;\n  * palliative radiation treatment within 14 days;\n  * chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;\n  * experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;\n  * chemotherapy regimen containing an alkylating antineoplastic agent (cyclophosphamide, chlorambucil, melphalan, or ifosfamide), alkylating-like (platinumbased chemotherapeutic drugs, platinum analogues), and non-classical alkylating agent (dacarbazine, temozolomide) within 28 days.\n* Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4 and are not able to safely stop these medications are excluded from this study; patients must stop strong CYP3A4 inhibiting\u002Finducing medications within 5 published half-lives and moderate within 3 published half-lives prior to the treatment initiation.\n\nNote: dihydropyridine calcium - channel blockers are permitted for management of underling disease\n\n* Subjects with cardiomyopathy diagnosed within 6 months prior to treatment initiation including but not limited to the following:\n\n  * hypertrophic cardiomyopathy\n  * arrhythmogenic right ventricular cardiomyopathy\n  * abnormal ejection fraction (echocardiogram \\[ECHO\\]) \\\u003C= 53% (if a range is given then the upper value of the range will be used)\n  * previous moderate or severe impairment of left ventricular systolic function (LVEF \\\u003C45%)\n  * severe valvular heart disease\n  * atrial fibrillation with a ventricular rate \\>100 bpm on EKG at rest\n  * Fridericia's corrected QT interval (QTcF) \\>= 480 msec (adults) or \\>= 460 msec (pediatric subjects, aged 12 to \\\u003C18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.\n* HIV, HCV, HBV positive patients on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current study and possible for adverse pharmacokinetic and\u002For pharmacodynamic interactions.\n* Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Note: subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded.\n* Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.\n* Subjects with central nervous system (CNS) metastases or CNS disorders known to increase possible neurotoxicity of metarrestin in case of compromised blood-brain barrier (e.g. recent stroke (\\\u003C3 months of treatment initiation), infectious causes).\n* Significant acute or chronic infections including tuberculosis with presence of clinical symptoms or physical findings.\n* Patients with a history of any seizures or increased risk of seizures on screening EEGs defined by 1) interictal epileptiform discharges, 2) temporal intermittent rhythmic delta activity (TIRDA), or 3) electrographic or clinical seizures on EEG.\n* Clinically relevant diseases (for example, inflammatory bowel disease) and \u002F or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.\n* Patients with previous gastric bypass, patients receiving nutrition via feeding tubes or parenterally, or patients with malabsorptive conditions (damage to the intestine from infection, inflammation, trauma, or surgery, celiac disease, Crohn's disease, chronic pancreatitis, or cystic fibrosis resulting malabsorption). Patients with refractory nausea and vomiting. Note: patients with gastric banding are allowed.\n* Pregnant individuals.","12 Years","120 Years",{"count":96,"type":20},116,[23],"Background:\n\nMetastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs.\n\nObjective:\n\nTo find a safe dose of metarrestin and to see if this dose shrinks tumors.\n\nEligibility:\n\nAdults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options.\n\nDesign:\n\nParticipants will be screened with:\n\n* blood tests\n* physical exam\n* documentation of disease confirmation or tumor biopsy\n* electrocardiogram to evaluate the heart\n* review of their medicines and their ability to do their normal activities\n\nParticipants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary.\n\nParticipants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body.\n\nAdult participants may have tumor biopsies.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.\n\n...",[27,100,101,102,103,104],"Metastatic Pancreatic Cancer","Pediatric Solid Tumor","Advanced Breast Cancer","Malignant Peripheral Nerve Sheath Tumor","Colorectal Neoplasms",[106,107,108,109,110],"First-In-Class Investigational Agent","Peri-Nucleolar Compartment (PNC)","effective therapies against metastasis","Oral Administration","Maximum Recommended Starting Dose",{"date":79,"type":32},{"date":113,"type":32},"2020-10-27",{"date":115,"type":20},"2028-12-31",{"name":117,"class":118},"National Cancer Institute (NCI)","NIH",2,{"id":121,"slug":4,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100633258","NCT07524348","A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors","A Phase I, Open-Label, Multi-Center, First-in-Human Trial to Investigate E303, in Participants With Advanced Refractory Solid Tumors","Inclusion Criteria:\n\n* Histologically-confirmed, locally advanced (unresectable) or metastatic solid tumors with recurrence or progression during or after standard therapy, intolerance to standard therapy, refused to receive standard therapy, or for whom no standard therapy is available.\n\nExclusion Criteria:\n\n* Have spinal cord compression or clinically active central nervous system metastases\n* Have leptomeningeal disease\n* Have thromboembolic or clinically significant bleeding events\n* Have significant cardiovascular disease\n* Have an active autoimmune disease",{"count":127,"type":20},149,[23],"This is a Phase I trial to evaluate the safety, tolerability and efficacy of nectin-4 targeting antibody-drug conjugate (SBE303) in participants with advanced solid tumors",[27],"2026-06-28",{"date":133,"type":32},"2026-06-30",{"date":135,"type":32},"2026-03-23",{"date":137,"type":20},"2030-07",{"name":139,"class":38},"Samsung Bioepis Co., Ltd.",5,{"id":142,"slug":4,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":152,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":4},"100645248","NCT07681674","Bicycle Continued Access Protocol (BiCAP) for Participants Receiving a Bicycle Investigational Product","Bicycle Continued Access Protocol (BiCAP) for Participants Receiving a Bicycle Investigational Product on a BicycleTx Limited-Sponsored Study","Inclusion Criteria:\n\n* Participants must be receiving a Bicycle investigational product in another Bicycle-sponsored clinical study and will benefit from continued study treatment as assessed by the Investigator. The participant must be tolerating the treatment and the disease being treated has not grown on the treatment and have not met a treatment discontinuation criterion on the parent study.\n* Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent.\n* Pregnancy must be avoided while on treatment and for up to 6.5 months following end of study treatment.\n* Participants must have completed testing requirements of the Bicycle-sponsored parent study.\n\nExclusion Criteria:\n\n* Participant is receiving pembrolizumab or nivolumab only, and has been treated for \\>24 months from start of therapy on the parent study.\n* Participant is receiving Bicycle investigational product post-disease progression.\n* Participant has a new medical condition requiring treatment with strong cytochrome P450 3A (CYP3A) inhibitor or inducer while receiving zelenectide pevedotin or nuzefatide pevedotin.",{"count":148,"type":20},16,[24],"BiCAP-201 trial offers continued access to Bicycle investigational product treatments zelenectide pevedotin, nuzefatide pevedotin, and BT7480 for participants currently receiving and deriving clinical benefit from one of these treatments in a Bicycle Therapeutics-sponsored clinical trial. Bicycle Therapeutics will continue to monitor longer term safety of these treatments.",[27],[153,154,155,156,157,158,27],"Continued Access Protocol","Zelenectide pevedotin","Nuzefatide pevedotin","BT7480","Bicycle Drug Conjugate (BDC)","Bicycle TICA","2026-06-26",{"date":79,"type":32},{"date":162,"type":20},"2026-08-01",{"date":164,"type":20},"2030-05-30",{"name":166,"class":38},"BicycleTx Limited",{"id":168,"slug":4,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":182,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":86},"100623492","NCT07397338","Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors","A Phase 1\u002F2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS.\n* Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration).\n* Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \\& B for Part 2 Dose Expansion).\n* Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion).\n* Measurable disease per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Head and neck squamous cell carcinoma.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 4 weeks prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.\n* Other inclusion\u002Fexclusion criteria may apply.",{"count":174,"type":20},370,[23,24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.",[27,178,179,180,73,181],"Metastatic Solid Tumors","Non-small Cell Lung Cancer (NSCLC)","NSCLC","CRC",[27,178,183,180,184,181,185,186,187,188,189],"Non-small Cell Lung Cancer","Colorectal Cancer","RAS","NRAS","KRAS","HRAS","RAS Mutation",{"date":191,"type":32},"2026-06-29",{"date":193,"type":32},"2026-01-30",{"date":195,"type":20},"2029-05",{"name":197,"class":38},"Revolution Medicines, Inc.",{"id":199,"slug":4,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"100545626","NCT06384352","Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors","A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.\n2. Aged ≥18 years.\n3. Be able and willing to comply with protocol visits and procedures.\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or\n5. Adequate organ and bone marrow function.\n\nFor Part 1: History of an advanced solid tumors (including locally advanced unresectable or metastatic NSCLC, metastatic colorectal carcinoma (mCRC), advanced gastric adenocarcinoma (GAC)\u002F gastroesophageal junction adenocarcinoma (GEJA), pancreatic ductal adenocarcinoma (PDAC), hepatocellular carcinoma (HCC), intrahepatic biliary tract cancer (ih-BTC), and head and neck squamous cell carcinoma (HNSCC) who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit.\n\nFor Part 2: For patients with CRC: History of histologically or cytologically confirmed diagnosis of metastatic CRC and at least 2 prior regimens of standard treatment For patients with NSCLC: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic NSCLC and no more than 2 lines of prior cytotoxic systemic therapy in the locally advanced or metastatic setting.\n\nFor Part 3: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous (Part 3A) or squamous (Part 3B) NSCLC and no more than 2 lines of prior systemic therapy\n\nFor Part 4: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC who have progressed on or after 1 or 2 prior lines of systemic therapy\n\nFor Part 5 and Part 6 Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and\u002For definitive chemoradiotherapy and no prior systemic treatment for advanced unresectable or metastatic NSCLC\n\nExclusion Criteria:\n\n1. Prior treatment with an agent targeting c-MET (including antibody, ADC, chimeric antigen receptor T cell \\[CAR-T\\], and other drugs) with the exception of prior treatment with MET-targeted TKIs which are allowed.\n2. Previously received an ADC consisting of a TopoI\n3. Received continuous systemic steroids therapy for more than 28 days or require long-term (≥ 28 days) use of systemic steroids therapy within 28 days before the first administration, or have other acquired or congenital immune deficiency diseases. (Note: The protocol lists specific situational exceptions immediately following this clause).\n4. A history of leptomeningeal carcinomatosis or carcinomatous meningitis\n5. Brain metastasis, except for the following situations:\n\n   Participants with asymptomatic brain metastasis who do not require immediate local or systemic treatment (such as mannitol or steroids, surgery, or radiotherapy) are allowed to be enrolled If the participant's brain metastasis is treated and the condition of the metastasis is stable (brain imaging examination at least 2 weeks before the first administration shows that the lesion is stable, there is no evidence of new or original brain metastasis enlargement, there are no new neurological symptoms, and immediate local or systemic treatment is not required), admission is allowed\n6. Clinically significant concomitant pulmonary disease, including but not limited to:\n\nA history of drug-induced pneumonitis A history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that requires steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening",{"count":205,"type":20},500,[23],"This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of six parts. Objectives for Dose-Escalation Parts (Part 1 and Part 4) To evaluate the safety and tolerability of YL211 as monotherapy in patients with selected advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second or third line locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) (Part 4) To determine the maximum tolerated dose (MTD) and select the recommended expansion dose(s) (RED(s)) of YL211 as monotherapy in patients with advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second line locally advanced unresectable or metastatic non-squamous NSCLC (Part 4) Objectives for Backfill Enrollment Parts (Part 2 and Part 5) To better estimate and characterize the safety and efficacy of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) To select the RED(s) of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) Objectives for the Dose-Expansion Parts (Part 3 and Part 6) To further characterize the safety and efficacy of YL211 as monotherapy (Part 3) in patients with locally advanced unresectable or metastatic non-squamous or squamous NSCLC and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non- squamous NSCLC (Part 6) To compare the clinical activity of YL211 in combination with pembrolizumab against pembrolizumab, pemetrexed, and platinum-based chemotherapy (cisplatin or carboplatin) in participants with previously untreated advanced unresectable or metastatic non-squamous NSCLC (Part 6)",[27],"2026-06-24",{"date":191,"type":32},{"date":212,"type":32},"2024-05-01",{"date":214,"type":20},"2031-06-30",{"name":216,"class":38},"MediLink Therapeutics (Suzhou) Co., Ltd.",21,{"id":219,"slug":4,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":119},"100624671","NCT07412665","A Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.","A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Subjects With Advanced Solid Tumors.","Inclusion Criteria:\n\n* Ability to understand and sign a written informed consent document.\n* At the date of signing ICF, 18 \\~70 years old, male or female.\n* Histologically or cytologically confirmed advanced solid tumors, progressed on standard treatment, or intolerant to standard treatment, or without standard treatment; locally recurrent disease must be unsuitable for radical surgical resection or radiotherapy.\n* At least one measurable lesion that has not been irradiated or received other local therapies.\n* At least one measurable lesion remains (RECIST 1.1 criteria).\n* ECOG 0-1 points.\n* Expected survival time more than 3 months.\n* Adequate hematologic and organ function.\n* No absolute or relative contraindications to surgery, bronchoscopy, or percutaneous procedures.\n\nExclusion Criteria:\n\n* History of severe allergy, or hypersensitivity to any component of the drugs used in this study, including but not limited to lymphodepleting chemotherapy drugs, contrast agents for radiological examinations, and excipients of GK01 (such as dimethyl sulfoxide).\n* Any investigational drug or systemic anti-tumor therapy within 28 days prior to the start of lymphodepleting chemotherapy preconditioning, or within 5 half-lives of the previous drug.\n* Extensive field radiotherapy within 28 days prior to ICF signing, exception of local radiotherapy for symptomatic palliation of non-target lesions.\n* Major surgery within 28 days prior to signing the ICF, or planned during the study period.\n* Toxicities from previous anti-tumor therapies have not recovered to ≤ Grade 1 or baseline level (according to NCI-CTCAE version 5.0) at the time of signing the ICF, with the exception of alopecia and hyperpigmentation.\n* Any uncontrolled active infection requiring parenteral antibiotic, antiviral, or antifungal therapy within 4 weeks prior to signing the ICF or before the first infusion.\n* History of or current active autoimmune disease that has the potential to recur (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or subjects at such risk.\n* Prior history of bone marrow or organ transplantation.\n* Concurrent or prior history of interstitial lung disease or interstitial pneumonia.\n* History of active tuberculosis infection within 1 year prior to screening (subjects with a history of active tuberculosis infection more than 1 year ago may be enrolled if the investigator confirms there is no current evidence of active tuberculosis).\n* History of other primary malignancies within 5 years prior to the initiation of the study treatment.\n* Clinically significant cardiovascular disease.\n* History of bleeding within 6 months prior to signing the ICF.\n* Metabolic disorders, such as diabetes mellitus (with glycated hemoglobin \\[HbA1c\\] ≥8.5%), or other non-malignant organ or systemic diseases, or secondary reactions to cancer that may lead to high medical risk and\u002For uncertainty in survival assessment.\n* Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders.\n* Live\u002Fattenuated or inactivated vaccine within 28 days prior to signing the ICF, or planned administration of a live\u002Fattenuated or inactivated vaccine during the screening period.\n* Systemic corticosteroid therapy (at a dose equivalent to or greater than 10 mg\u002Fday of prednisone) or other immunosuppressive medications within 14 days prior to tissue acquisition or during the study period.\n* Hepatitis B surface antigen (HBsAg) positivity; With negative HBsAg positive hepatitis B core antibody (HBcAb) ,and if peripheral blood hepatitis B virus (HBV) DNA positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Both Treponema pallidum-specific and non-specific antibody tests are positive.\n* Female subjects who are pregnant or breastfeeding.","70 Years",{"count":226,"type":20},10,[228],"EARLY_PHASE1","This study is an open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.",[27],"2026-06-23",{"date":233,"type":32},"2026-06-25",{"date":235,"type":20},"2026-06",{"date":237,"type":20},"2028-03-31",{"name":239,"class":38},"Beijing Geekgene Technology Co., LTD",{"id":241,"slug":4,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":249,"conditions":250,"keywords":251,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":39},"100613425","NCT07266428","A Study of OTP-01, a Dual Paratopic PD-1\u002FVEGFR2 Antibody, in Patients With Advanced Solid Tumors","Phase 1\u002F2A Study of OTP-01, a Dual Paratopic PD-1\u002FVEGFR2 Antibody, in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced (incurable, recurrent, unresectable, or metastatic) solid tumors.\n\n   1. For dose escalation cohort patients: patients must have a tumor type as defined in the protocol. Patients will have progression on or after or intolerance to most recent systemic therapy. Patients must have received approved standard therapy that is available to the patient that is known to confer clinical benefit, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient. The reason for treatment decline must be clearly documented in the medical record.\n   2. For backfill cohorts: patients must have a tumor type as defined in the protocol. If patients decline an available standard therapeutic regimen known to confer benefit to enroll on this study, the discussion must be clearly documented in the medical record.\n2. Measurable disease per RECIST v1.1. Additionally, patients with breast or ovarian cancer with non-measurable, evaluable disease are eligible.\n3. ECOG performance status 0-1.\n4. Life expectancy of at least 3 months.\n5. Willing to provide a pretreatment tumor sample (either an archival sample or a sample obtained by pretreatment biopsy).\n6. All toxicity resulting from prior cancer therapies must have resolved to NCI CTCAE v5.0 ≤ Grade 1 or pre-therapy baseline with the exception of alopecia or ≤ Grade 2 neuropathy.\n7. Adequate hematological, renal, and hepatic function.\n8. Other protocol-defined inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Receiving systemic corticosteroids at prednisone-equivalent dose of \\> 10 mg\u002Fday within 4 weeks prior to signing consent. Chronic systemic corticosteroid therapy for physiologic replacement (≤ 10 mg\u002Fday of prednisone equivalents) and the use of non-systemic corticosteroids (e.g., inhaled, topical, intra-nasal, intra-articular, or ophthalmic) are permitted\n2. History of Grade 4 allergic or anaphylactic reaction to prior monoclonal antibody therapy or allergic reaction to any excipients within the investigational product\n3. History of toxicity requiring permanent discontinuation of prior cancer immunotherapy\n4. Have an active autoimmune disease that has required systemic treatment in past 2 years (replacement therapy is not considered a form of systemic treatment)\n5. History of organ or stem cell transplant or need for immunosuppressive treatment\n6. Have proteinuria \\> 2 + (within 7 days prior to initiation of study treatment).\n7. Received any chemotherapy, immunotherapy or investigational anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter; minimum of 2 weeks) prior to first dose of study drug\n8. Definitive radiotherapy within 6 weeks and palliative radiation within 2 weeks prior to the first dose of study drug. If previously irradiated, lesions must have demonstrated clear-cut progression prior to being eligible for evaluation as target lesions\n9. Other protocol and subprotocol-defined exclusion criteria apply",{"count":247,"type":20},170,[23,24],"The main goals of this clinical trial are to find out what the best dose of the study drug, OTP-01, is for patients with solid tumors through understanding how it is tolerated and any side effects that it may cause. The trial will also see if OTP-01 causes tumors to shrink and how the body processes OTP-01 by measuring drug levels in the blood.\n\nThe main questions this study aims to answer are:\n\n* What is the recommended dose of OTP-01 for adults with solid tumors?\n* Is OTP-01 safe and tolerable?\n* Does OTP-01 reduce tumor growth?\n\nParticipants will:\n\n* Receive OTP-01 through an infusion into a vein. Doses will be spaced out and never more than once a week.\n* Have blood tests to evaluate safety and drug levels of OTP-01. These will be done often at first and then less frequently as treatment continues.\n* Have radiographic scans of their tumor at baseline and during the study at regular intervals.\n* Have the choice to have an optional tumor biopsy before and after treatment to help researchers understand how OTP-01 affects cancer and the immune system. These biopsies are voluntary and will not affect participation in the study.",[27],[252],"advanced solid tumors","2026-06-22",{"date":231,"type":32},{"date":256,"type":32},"2025-12-17",{"date":258,"type":20},"2028-12",{"name":260,"class":38},"Ottimo Pharma Limited",{"id":262,"slug":4,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":21,"phases":269,"briefSummary":270,"conditions":271,"keywords":272,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":286},"100480262","NCT05533697","Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors","Phase 1\u002F2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Males or females ≥18 years of age who have provided written informed consent prior to completing any study-specific procedure. For Arm 2d, participants ≥12 years are eligible with informed consent\u002Fassent.\n* Dose Escalation (Arm 1a): Participant has histologically confirmed locally advanced or metastatic cancer (cutaneous melanoma, NSCLC, non-muscle invasive bladder cancer, head and neck squamous cell carcinoma, microsatellite stable colorectal cancer \\[MSS CRC\\], basal cell carcinoma, or triple negative breast cancer) with measurable disease as determined by RECIST v1.1. Arm 1a participants must have received, and then progressed, relapsed, or been intolerant to, or ineligible for, at least 1 standard treatment regimen in the advanced or metastatic setting. Participants with a known driver mutation must have also received or been offered a mutation-directed therapy, where indicated. Participants must have a tumor lesion amenable to biopsy and must have another lesion that can be followed for response.\n* Dose Confirmation (Arm 1b): Participant has histologically confirmed locally advanced or metastatic, and CPI refractory melanoma or locally advanced or metastatic, and CPI refractory NSCLC with measurable disease as determined by RECIST v1.1 who has disease progression after, at least 1 line of standard therapy (no limit to prior lines of therapy), and has been treated with or refused standard of care treatment. Participants in PD arm Group 2 must also have PD-L1 TPS ≥1%. Participants must have primary refractory or acquired secondary resistance to prior immune checkpoint treatments. Primary refractory is defined as prior exposure to anti-programmed death-1 (PD-1)\u002FPD-L1 antibody for at least 6 weeks but no more than 6 months with demonstration of progression on 2 separate scans at least 4 weeks apart but no more than 12 weeks apart and progression occurring within 6 months after first dose of anti-PD-1 antibody. Acquired secondary resistance must have confirmed objective response or prolonged stable disease (SD) (\\>6 months), followed by disease progression in the setting of ongoing treatment and confirmed progression on scans at least 4 weeks apart. Participants must have a tumor lesion amenable to biopsy and must have another lesion that can be followed for response.\n\n  1. For NSCLC participants with known EGFR, ALK, proto-oncogene tyrosine-protein kinase reactive oxygen species (ROS1), or other actionable mutations for which there are approved targeted therapies, participants must have received prior approved targeted therapy or have been offered and declined approved targeted therapy.\n  2. Expansion of the melanoma Arm 1b cohort (up to approximately 16 additional evaluable participants) will require prospective central testing of Screening tumor biopsies to confirm PD-L1 TPS ≥1% for eligibility.\n* Dose Expansion Arms (Arm 2): Participant has histologically confirmed:\n\n  1. Arm 2a: Locally advanced or metastatic melanoma who have not yet received any prior systemic therapy for their melanoma in this setting.\n  2. Arm 2b: Newly diagnosed locally advanced or metastatic NSCLC with a PD-L1 TPS of ≥50% with no known EGFR or ALK positive tumor mutations who have not yet received any prior systemic therapy for their NSCLC (that is, treatment-naive).\n  3. Arm 2c: Locally advanced or metastatic melanoma in participants who have not received prior systemic therapy for melanoma in the advanced\u002Fmetastatic setting.\n  4. Arm 2d: Advanced\u002Fmetastatic melanoma that is CPI refractory and having a centrally confirmed PD-L1 TPS of ≥1% on their Screening tumor biopsy.\n* All participants must have measurable disease as determined by RECIST v1.1.\n* Participants must have a tumor lesion amenable to biopsy and must provide tumor biopsy sample at baseline (archival formalin-fixed, paraffin-embedded \\[FFPE\\] tissue collected within 90 days of informed consent is accepted as long as no intervening therapy is received, during this time), and optionally at all on-treatment timepoints (including response or progression) if medically feasible. Participants in Arm 2c: Sufficient tumor tissue (slides or FFPE block) for PD-L1 testing is required as per Laboratory Manual. Participants in Arm 2c may be replaced in this cohort if not PD-L1 evaluable. Participants in Arm 1b melanoma expansion cohort and Arm 2d: Central confirmation of PD-L1 TPS score is required prior to enrollment.\n* If the participant is undergoing a new biopsy, they must have another lesion outside of the lesion biopsied at baseline that can be followed as a RECIST v1.1 target lesion for response.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n* Participant has adequate hematological and biological function.\n\nKey Exclusion Criteria:\n\n* Participant has active central nervous system tumors or metastases.\n* Participant has received treatment with prohibited medications (that is, concurrent anticancer therapy including other chemotherapy, radiation \\[local radiation for palliative care is permitted with approval from the Sponsor\\], hormonal anticancer treatment, biologic therapy, or immunotherapy) or investigational agents within 5 half-lives or 14 days prior to the first day of study treatment, whichever is shorter. Prior exposure to any investigational or approved agent designed to simultaneously target both indoleamine 2,3-dioxygenase (IDO1) and PD-L1 is also exclusionary.\n* Participant has required the use of additional immunosuppression (for example, infliximab) other than corticosteroids for the management of an AE, has experienced recurrence of an AE if rechallenged, and currently requires maintenance doses of \\>10 milligrams (mg) prednisone or equivalent per day.\n* Participant has any plan to receive a live attenuated vaccine during study treatment or has received a live vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines and non-live coronavirus disease 2019 (COVID-19) for injection are generally allowed.\n* Participant has reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and prespecified laboratory values.\n* Participant who is pregnant, breastfeeding, or is of childbearing potential, defined as those who are capable of becoming pregnant who are not willing to employ a highly effective method of contraception during dosing and for 90 days after the last dose of mRNA-4359 or 4 months after the last dose of pembrolizumab or 5 months after the last dose of ipilimumab\u002Fnivolumab administrations, whichever is longer.\n* Sexually active participants who refuse to use a condom during intercourse or participants who will not refrain from sperm donation while taking study treatment and for 90 days after the last dose of mRNA-4359 or 4 months after the last dose of pembrolizumab or 5 months after the last dose ipilimumab\u002Fnivolumab, whichever is longer, or who will not refrain from sperm donation for the same time period.\n* Participant has any unstable or clinically significant concurrent medical condition (for example, substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism) that would, in the opinion of the Investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and\u002For impact their ability to comply with the protocol. Also including but not limited to, ongoing or active infection, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, active gastrointestinal bleeding or hemoptysis or history of bleeding disorder, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the participant to give written informed consent.\n* Participant has concurrent enrollment in another clinical study (unless it is an observational noninterventional clinical study).",{"count":268,"type":20},361,[23,24],"The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab.",[27],[273,274,275,276,277,278],"Locally advanced","Metastatic","Relapsed or refractory solid tumor malignancies","Pembrolizumab","Oncology","Solid tumors",{"date":231,"type":32},{"date":281,"type":32},"2022-09-01",{"date":283,"type":20},"2032-02-18",{"name":285,"class":38},"ModernaTX, Inc.",34,{"id":288,"slug":4,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":21,"phases":296,"briefSummary":297,"conditions":298,"keywords":299,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":119},"100597630","NCT07060989","A Study of Safety, Tolerability and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation","A Phase 1\u002F2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation","NTS071","Inclusion Criteria:\n\n1. Male or female subjects, ≥ 18 years\n2. Advanced solid tumors with TP53 Y220C mutation\n3. Previously treated with one or more lines of anticancer therapy and progressive disease\n4. At least one measurable lesion according to RECIST version 1.1 criteria\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1\n6. Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n1. Known CNS primary tumor and active or untreated CNS metastases\n2. History of another primary malignancy that has been diagnosed or required therapy within the past 2 years\n3. Toxicities of prior therapy have not been resolved to ≤ Grade 1 or to baseline\n4. Significant cardiovascular disease, including congestive heart failure\n5. Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active\n6. Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.",{"count":295,"type":20},220,[23,24],"This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.",[27],[27,300],"TP53 Y220C","2026-06-21",{"date":209,"type":32},{"date":304,"type":32},"2025-08-04",{"date":306,"type":20},"2029-12",{"name":308,"class":38},"Nutshell Therapeutics (Shanghai) Co., LTD.",{"id":310,"slug":4,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":21,"phases":317,"briefSummary":318,"conditions":319,"keywords":320,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100592470","NCT06993844","Phase 1\u002F2 Study of ETX-636 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.\n* Tumor harboring an activating PIK3CA mutation detected in either tumor tissue or ctDNA.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status score of 0 or 1.\n* Adequate organ function.\n\nAdditional key inclusion criterion for Parts B and C:\n\n\\- Confirmed metastatic or locally advanced HR+\u002FHER2- breast cancer not amenable to surgical resection with curative intent and must have received at least 1 prior CDK4\u002F6 inhibitor and at least 1 prior anti-estrogen therapy.\n\nKey Exclusion Criteria:\n\n* Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.\n* Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.\n* Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2.\n* Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.\n* Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.\n* Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.",{"count":316,"type":20},233,[23,24],"Phase 1\u002F2, open-label study of ETX-636 in participants with advanced solid tumors",[27,102],[321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350],"cancer","breast cancer","solid tumors","PIK3CA","PI3Kα inhibitor","Breast Neoplasms","Neoplasms by Site","Neoplasms","Breast Diseases","HER2-negative breast cancer","HR-positive breast cancer","Gynecologic cancer","Endometrial cancer","Ovarian cancer","Cervical cancer","Head and neck cancer","Head and neck squamous cell carcinoma","Fulvestrant","Antineoplastic Agents","PI3Kα","PI3K alpha","PI3Kα mutation","Alpelisib","Estrogen Receptor Antagonists","Estrogen Antagonists","Hormone Receptor Antagonists","Hormone Antagonists","Hormones, Hormone Substitutes, and Hormone Antagonists","Physiological Effects of Drugs","PIK3CA mutation",{"date":231,"type":32},{"date":353,"type":32},"2025-06-10",{"date":355,"type":20},"2027-12-30",{"name":357,"class":38},"Ensem Therapeutics",15,{"id":360,"slug":4,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":119},"100638825","NCT07601243","Study of GS-2426 in Participants With Advanced Solid Tumors","A Phase 1, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Tolerability of GS-2426 in Participants With Advanced MTAP-Deleted Solid Tumors","Key Inclusion Criteria:\n\n* Participants 18 years of age or older (≥ 19 years old for participants in South Korea).\n* Histologically or cytologically confirmed advanced malignant solid tumors, who have progressed on, are intolerant to or are ineligible for standard therapy, or have no standard treatment options.\n* Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient.\n* Adequate organ function\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* All participants must provide a pretreatment tumor tissue sample.\n\nKey Exclusion Criteria:\n\n* Participants with plans to breastfeed during the study period or within 7 days following the last dose of study intervention.\n* Have not recovered (ie, returned to Grade 1 or baseline) from clinically significant adverse events (AEs) due to a previously administered agent or a previous intervention as assessed by the investigator.\n* Active second malignancy. Individuals with a history of malignancy who have been completely treated with no evidence of active cancer for 5 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence may be enrolled.\n* Requirement for ongoing therapy with any prohibited medications .\n* Prior therapy with a protein arginine methyltransferase 5 (PRMT5) inhibitor or methionine adenosine transferase 2a (MAT2A) inhibitor.\n* Have serious infection requiring antibiotics within 14 days prior to the first dose.\n* Uncontrolled concurrent diseases\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":366,"type":20},174,[23],"The goal of this clinical study is to learn more about the study drug GS-2426, and how safe and tolerable it is in participants with advanced methylthioadenosine phosphorylase (MTAP)-deleted solid tumors.\n\nThe primary objective of this study is to evaluate the safety and tolerability of GS-2426 in participants with MTAP-deleted advanced solid tumors and to determine the maximum tolerated dose (MTD)\u002Fmaximum administered dose (MAD) and the recommended phase II dose (RP2D).",[27],"2026-06-19",{"date":209,"type":32},{"date":373,"type":32},"2026-06-02",{"date":375,"type":20},"2029-01",{"name":377,"class":38},"Gilead Sciences",{"id":379,"slug":4,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":21,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100580714","NCT06840886","A Study of PHST001 in Advanced Solid Tumors","An Open-label, Phase 1a\u002F1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and\u002For Refractory Solid Tumors","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies.\n* Adequate organ function per laboratory testing\n* Pregnancy prevention requirements\n* Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator\u002Fradiology\n* Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale\n\nKey Exclusion Criteria:\n\n* Diagnosis of immunodeficiency\n* History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded.\n* Active known CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are radiologically stable (i.e., without evidence of progression for at least 2 weeks by repeat imaging \\[note that the repeat imaging should be performed during study screening\\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.\n* Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant.\n* Received previous treatment with another agent targeting CD24.",{"count":385,"type":20},272,[23],"This is a multi-center, first-in-human (FIH), open-label, Phase 1a\u002F1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) in adult participants with advanced relapsed and\u002For refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and\u002For refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.",[27,389,390,391,392],"Ovarian Cancer","Endometrial Cancer","Cholangiocarcinoma","CNS Tumor","2026-06-18",{"date":231,"type":32},{"date":396,"type":32},"2025-03-31",{"date":398,"type":20},"2031-04",{"name":400,"class":38},"Pheast Therapeutics",20,{"id":403,"slug":4,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":21,"phases":410,"briefSummary":411,"conditions":412,"keywords":413,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":423},"100561923","NCT06596473","A Study of BG-C477 in Participants With Advanced Solid Tumors","A Multicenter, Open-Label, Phase 1a\u002Fb First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must sign the informed consent form (ICF) and be capable of giving written informed consent\n* Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy\n* Phase 1a (Dose Escalation): Histologically confirmed advanced, metastatic, or unresectable solid tumors, that were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator\n* Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy\n* Phase 1b (Dose Expansion) Part B: Histologically confirmed advanced or metastatic select solid tumors who have previously received 0 or 1 line of systemic therapy for advanced disease\n* ≥ 1 measurable lesion as assessed by RECIST v1.1\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1\n* Adequate organ function\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 8 months after the last dose of BG-C477, for ≥ 6 months after the last dose of chemotherapy, and for ≥ 4 months after the last dose of tislelizumab,whichever comes later\n* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 5 months after the last dose of BG-C477, for ≥ 3 months after chemotherapy, and for ≥ 4 months after the last dose of tislelizumab, whichever comes later.\n\nExclusion Criteria:\n\n* Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload\n* History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n* Any malignancy ≤ 2 years before the 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 (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":409,"type":20},310,[23],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.",[27],[414,252,415],"BG-C477","CEA ADC",{"date":253,"type":32},{"date":418,"type":32},"2024-10-03",{"date":420,"type":20},"2027-12-31",{"name":422,"class":38},"BeOne Medicines",54,{"id":425,"slug":4,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":21,"phases":432,"briefSummary":433,"conditions":434,"keywords":437,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":60},"100608993","NCT07208773","A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors","A Multi-center, Open-label, Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of YL201 in Combination With Ivonescimab in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Inclusion criteria for the study population： Phase 1: Advanced Solid tumors. Phase 2: Extensive-stage SCLC, Non-AGA NSCLC, EGFR mutation NSCLC.\n3. ECOG PS score is 0 or 1.\n4. Within 7 days before the first dose, the functions of body organs and bone marrow meet the requirements.\n\nExclusion Criteria:\n\n1. Suitable for local curative treatment.\n2. Have received previous treatment with drugs targeting B7-H3 (including antibodies, ADCs, CAR-T, and other drugs).\n3. Have received previous treatment with topoisomerase I inhibitors or ADCs containing topoisomerase I inhibitors.\n4. Have experienced grade ≥ 3 irAEs during previous treatment with anti-programmed death receptor (ligand) \\[anti-PD-(L)1\\] or other immune checkpoint inhibitors.\n5. History of bleeding tendency or coagulation disorders and\u002For clinically significant bleeding symptoms or risks within 4 weeks before randomization.\n6. Imaging studies during the screening period show that the patient has the Imaging-confirmed tumor invasion of major blood vessels.\n7. Active autoimmune disease requiring systemic treatment.\n8. Brain metastases or spinal cord compression.\n9. Patients with uncontrolled or clinically significant cardiovascular diseases.\n10. Clinically significant concurrent pulmonary diseases.\n11. Known to have active pulmonary tuberculosis. Other protocol-defined inclusion\u002F exclusion criteria may apply",{"count":431,"type":20},260,[23,24],"This study was designed to evaluate the efficacy and safety of YL201 in combination with Ivonescimab (AK112) in subjects with solid tumor.",[27,435,436],"Non Small Cell Lung Cancer","Small Cell Lung Cancer",[438,439,440,435,436],"Advanced solid tumors","PD1\u002FVEGF Bispecific","Antibody drug conjugate","2026-06-17",{"date":393,"type":32},{"date":444,"type":32},"2025-10-29",{"date":446,"type":20},"2027-12",{"name":216,"class":38},{"id":449,"slug":4,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":21,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":464,"locationsCount":140},"100533364","NCT06224855","A Study of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies","An Open-label Dose Escalation and Cohort Expansion Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and and Efficacy of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies","Inclusion Criteria:\n\n1. The patient voluntarily signed the informed consent form and followed the protocol requirements.\n2. Gender is not limited.\n3. Age ≥ 18 years old.\n4. Expected survival time ≥ 3 months.\n5. The Eastern Cooperative Oncology Group (ECOG) score 0-2.\n6. Subjects may provide biopsy or archival tumor tissue samples for the central laboratory to confirm expression levels of Target protein.\n7. Patients with solid tumors or hematologic tumors who have failed standard therapy, including small cell lung cancer, multiple myeloma, neuroblastoma, etc..\n8. Patients who have received ASCT treatment must meet the following conditions:\n\n   1. ASCT \\> 100 days from start of study treatment.\n   2. no active infection.\n9. Toxicity from prior antineoplastic therapy has recovered to Grade ≤ 1 (except alopecia) as defined by NCI-CTCAE v5.0, including peripheral neuropathy ≤ Grade 2.\n10. Organ function must meet the following requirements: blood routine:\n\n(1) Patients with multiple myeloma: absolute neutrophil count (ANC) ≥ 1.0×109\u002FL (previous use of granulocyte colony-stimulating factor \\[G-CSF\\] is allowed, and G-CSF is not allowed within 7 days before laboratory examination during the screening period);Platelet count ≥ 50×109\u002FL (platelet transfusion is not allowed within 7 days before laboratory tests during the screening period).\n\nHemoglobin (HGB) ≥ 75 g\u002FL (prior red blood cell \\[RBC\\] transfusions or recombinant human erythropoietin are allowed; Within 7 days before the laboratory examination during the screening period, red blood cell transfusion is not allowed).\n\n(2) Other patients: Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL, Platelet count ≥ 100×109\u002FL, Hemoglobin (HGB) ≥ 90 g\u002FL Liver: total bilirubin (TBIL) ≤ 1.5×ULN, except for subjects with congenital bilirubinemia, such as Gilbert's syndrome (direct bilirubin ≤ 1.5×ULN); Glutamate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 3.0×ULN.\n\nIn the presence of liver metastases, both AST and ALT ≤ 5× ULN Kidney: creatinine clearance (Ccr) ≥ 30mL\u002Fmin in patients with multiple myeloma, Creatinine ≤ 1.5×ULN in other patients.\n\nCoagulation:\n\nInternational Normalized Ratio (INR) ≤ 1.5, Activated partial thromboplastin time (APTT) or prothrombin time (PT) ≤ 1.5× ULN.\n\ncorrected serum calcium ≤ 14 mg\u002FdL (≤ 3.5 mmol\u002FL). left ventricular ejection fraction (LVEF) ≥ 50%. 11. The patient and his\u002Fher spouse agree to take effective contraceptive measures (excluding contraception during the safe period) from the time of signing the informed consent form to 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Within 14 days before the first dose: received plasmapheresis; Treatment with \\> 10 mg of prednisone or equivalent doses of systemic corticosteroids per day for more than 3 consecutive days (short-term use for the prevention of contrast allergy can be enrolled).\n2. Patients have received systemic anti-myeloma therapy or investigational drug therapy within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; Radiotherapy within 14 days prior to the first dose.\n3. Patients have received monoclonal antibody therapy within 30 days before the first dose.\n4. Patients have received autologous hematopoietic stem cell transplantation within 100 days before the first dose.\n5. Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) or have a history of solid organ transplantation.\n6. Patients have received the same targeted therapy in the past (limited to phase Ia clinical trials).\n7. Patient has symptomatic brain metastases or meningeal metastases.\n8. The patient had symptomatic amyloidosis, active plasma cell leukemia, and active POEMS syndrome at the time of screening.\n9. There is evidence of cardiovascular risk, including any of the following: a. QTcF interval ≥ 470 ms (QT interval must be corrected by Fridericia formula \\[QTcF\\]). b. Evidence of currently clinically significant, untreated arrhythmias, including clinically significant electrocardiogram abnormalities such as degree 2 (Mobitz type II) or degree 3 atrioventricular conduction (AV) block. c. History of myocardial infarction, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty, or stenting or bypass grafting within 6 months prior to screening. d. Grade III or IV heart failure(New York Heart Association Functional Grading System). e. Uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n10. The patient has difficulty breathing or currently requires continuous oxygen therapy, or currently has active pneumonia or interstitial lung disease (except for mild cases as determined by the investigator).\n11. The patient has a history of other primary malignancies, except the following: cured malignancies with a very low risk of recurrence within 5 years, such as skin basal cell carcinoma and skin squamous cell carcinoma, carcinoma in situ of the cervix or breast.\n12. Patients have severe unhealed wound ulcers or fractures, or have undergone major surgery within 28 days prior to dosing or are expected to undergo surgery during the clinical study.\n13. Previous history of allergy to any component or excipient of DXC006.\n14. Active hepatitis B (HBV-DNA greater than the central upper limit of normal or HBV-DNA testing greater than 1000 copies \u002FmL); Hepatitis C infection (positive for hepatitis C antigen or positive for hepatitis C RNA PCR).\n15. Seropositive for human immunodeficiency virus (HIV); Active syphilis (patients with positive syphilis antibodies can be included); Possible active tuberculosis (chest imaging within 3 months prior to first dosing indicating active tuberculosis infection).\n16. Patients had active bleeding within 30 days prior to screening, or were at risk of massive gastrointestinal bleeding or hemoptysis as determined by researchers; Or have inherited bleeding tendencies or coagulation disorders, or bleeding symptoms that require other medical intervention.\n17. Severe arteriovenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first dose.\n18. Female patients with a positive serological pregnancy test or who are breastfeeding.\n19. Active infections requiring medical treatment (CTCAE≥2); Uncontrollable pleural fluid, ascites, pericardial effusion requiring repeated drainage;\n20. Received live attenuated vaccine within 28 days before the first dose.\n21. The patient has other conditions that the investigator or sponsor has determined may affect the study.",{"count":455,"type":20},280,[23],"This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological malignancies.",[27,459],"Hematological Malignancies",{"date":253,"type":32},{"date":462,"type":32},"2024-01-24",{"date":420,"type":20},{"name":465,"class":38},"Hangzhou DAC Biotechnology Co., Ltd.",{"id":467,"slug":4,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":21,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":485},"100444427","NCT05067283","A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)","A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors","KANDLELIT-001","Inclusion Criteria:\n\nFor all participants:\n\n* Has measurable disease by RECIST 1.1 criteria\n* Has adequate organ function\n* Male participants agree to protocol-specified contraception requirements including refraining from donating sperm and using protocol-specified contraceptives unless confirmed to be azoospermic\n* Female participants must not be pregnant or breastfeeding, and must agree to protocol-specified contraceptive requirements and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention\n\nFor Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease\n\nFor Arm 2\n\n\\- Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%\n\nFor Arm 3\n\n* Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease Expansion Group A: 2L+NSCLC\n* Has histologically or cytologically confirmed diagnosis of unresectable or metastatic NSCLC with histological or blood-based confirmation of KRAS G12C mutation and submits archival tumor sample\n* Previous treatment failure of at least 1 line of systemic therapy Expansion Group B\n* Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease\n\nArm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation\n\nArm 5 only\n\n* Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation\n* Previous treatment failure of one or 2 previous line(s) of systemic therapy\n\nArm 6 only\n\n\\- Locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation\n\nExclusion Criteria:\n\n* Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before first dose of study intervention\n* Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years\n* Has clinically active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has an active infection requiring systemic therapy\n* Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus infection\n* Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis\n* Has an active autoimmune disease requiring systemic therapy\n* Has not fully recovered from any effects of major surgical procedure without significant detectable infection\n* Has one or more of the following ophthalmological findings\u002Fconditions: intraocular pressure \\>21 mm Hg and\u002For any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and\u002For a diagnosis of retinal degenerative disease\n* Has received live or live-attenuated vaccine within 4 weeks of study start\n\nArm 4 Only\n\n* Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents \\[for example, piroxicam\\]) before, during, and for at least 2 days after administration of pemetrexed.\n* Is unable\u002Funwilling to take folic acid, vitamin B12, and dexamethasone",{"count":474,"type":20},830,[23],"This is a study evaluating the safety, pharmacokinetics, and efficacy of calderasib alone, and calderasib plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.",[27],{"date":253,"type":32},{"date":480,"type":32},"2021-12-17",{"date":482,"type":20},"2030-02-25",{"name":484,"class":38},"Merck Sharp & Dohme LLC",75,{"id":487,"slug":4,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":21,"phases":493,"briefSummary":494,"conditions":495,"keywords":496,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":504,"leadSponsor":505,"locationsCount":507},"100641429","NCT07622524","A Phase I Study of CS5007 in Participants With Advanced Solid Tumors","A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti Tumor Activities of CS5007, a Novel EGFR and HER3 Bispecific Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Evidence of a personally signed and dated informed consent document.\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Being ≥ 18 years of age on the day of signing informed consent.\n* Pathologically or cytologically confirmed, unresectable advanced solid tumors.\n* Participants must have at least one measurable lesion according to RECIST Version1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.\n* Adequate organ function.\n* Life expectancy ≥ 3 months.\n* Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study drug administration\n\nExclusion Criteria:\n\n* Has disease that is suitable for local treatment administered with curative intent.\n* Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.\n* Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is symptomatic, untreated, or requires therapy.\n* Has life-threatening bleeding event or severe bleeding within 3 months prior to first dose.\n* Has uncontrolled pleural effusion, pericardial effusion, or ascites.\n* Has immune deficient disease or received systemic immunosuppressive treatment.\n* Has intestinal obstruction,or history of inflammatory bowel disease,or chronic diarrhea.\n* Has history of (non-infectious) interstitial lung disease\u002Fpneumonitis that required steroids.\n* Has active infections requiring systemic therapy.\n* Has significant cardiovascular disease or cerebrovascular accident within specified timeframes prior to first dose.\n* Insufficient washout from prior anti-tumor therapy.\n* Received live vaccine within 28 days prior to first dose.\n* History of allogeneic organ or hematopoietic stem cell transplantation.\n* History of hypersensitivity to excipients of study drug or any monoclonal antibody.\n* Any toxic effects of prior therapy unresolved to Grade ≤1.\n* Active alcohol or drug abuse.\n* Pregnant or breastfeeding women.\n* Other acute or chronic medical or psychiatric conditions that may increase risk or interfere with study results, in the investigator's judgment.",{"count":409,"type":20},[23],"This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.",[27],[497,498,499,500,27],"EGFR","HER3","Bispecific Antibody-Drug Conjugate","Phase I","2026-06-16",{"date":393,"type":32},{"date":235,"type":20},{"date":375,"type":20},{"name":506,"class":38},"CStone Pharmaceuticals",7,{"id":509,"slug":4,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":21,"phases":516,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":525,"leadSponsor":527,"locationsCount":60},"100641775","NCT07650825","OVV-01 Intravenous and Intratumoral Injection Combined With AK112 for the Treatment of Advanced Solid Tumors","A Single-Arm, Open-Label Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of OVV-01 Administered Intravenously and Intratumorally in Combination With AK112 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. At least 18 years of age at the time of signing the ICF; gender is not restricted.\n2. Patients with advanced solid tumors confirmed by histopathological\u002Fcytological examination of the primary and\u002For metastatic lesions, including but not limited to: melanoma, head and neck squamous cell carcinoma, cervical cancer, osteosarcoma, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, hepatocellular carcinoma, gastric cancer, etc.\n3. Patients with advanced disease who have failed standard therapy, lack standard treatment options, or are medically ineligible for standard therapy. Patients must have progressed after receiving at least two standard therapies (including but not limited to targeted therapies).\n4. Subjects must have at least one measurable lesion as defined by RECIST 1.1 criteria, i.e., non-lymph node lesions ≥10 mm in longest diameter and lymph node lesions ≥15 mm in shortest diameter on CT or MRI. Injectable tumor lesions must be present, including superficial lesions and deep lesions amenable to injection under ultrasound\u002FCT\u002For endoscopic guidance.\n5. ECOG performance status of 0-1, with an estimated survival of at least 12 weeks.\n6. Sufficient organ and hematopoietic function.\n7. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.\n8. Male and female subjects of childbearing potential must agree to use reliable contraception during the trial and for at least 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with known brain metastases and\u002For clinically suspected brain metastases (however, patients with asymptomatic brain metastases or those clinically stable for over 3 months following local treatment may be enrolled);\n2. Subjects who underwent radiotherapy to the target lesion within the past 2 months (may be enrolled if the radiotherapy site progressed);\n3. Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, or subjects with malignancies within the scope of the indication;\n4. Largest diameter of lesions for injection \\>100 mm;\n5. Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks;\n6. Subjects scheduled for or who have previously undergone tissue\u002Forgan transplantation;\n7. Subjects with Human Immunodeficiency Virus (HIV) infection who have experienced AIDS-related opportunistic infections within the past 12 months, or who have a CD4+ T-cell (CD4+) count \\\u003C 350 cells\u002FuL; Patients screening positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with HBV-DNA above the lower limit of detection, or screening positive for HCV antibody with HCV-RNA above the lower limit of detection; subjects with positive syphilis serology;\n8. Subjects requiring antiviral therapy during the study period or within 5 half-lives of the first dose of antiviral therapy.\n9. Subjects requiring therapeutic anticoagulant therapy during the study period.\n10. Subjects with uncontrolled active infection ≥ Grade 3 according to CTCAE v5.0 that is clinically significant;\n11. Received antineoplastic therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to first dose; Received small-molecule targeted therapy or oral fluorouracil-based agents within 2 weeks prior to first dose or within 5 half-lives (whichever is longer); Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to the first dose; Received nitrosourea or mitomycin C within 6 weeks prior to the first dose; Palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to the first dose);",{"count":515,"type":20},30,[23],"This study is an open-label, multiple-route-of-administration dose-escalation clinical trial designed to evaluate the safety and preliminary efficacy of OVV-01 injection administered intravenously or intravenously plus intratumorally, either as monotherapy or in combination with AK112 injection, in subjects with advanced solid tumors.",[27],[520,521],"oncolytic virus","immunotherapy","2026-06-14",{"date":501,"type":32},{"date":162,"type":20},{"date":526,"type":20},"2027-01-31",{"name":528,"class":529},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",{"id":531,"slug":4,"hasResults":11,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":21,"phases":538,"briefSummary":539,"conditions":540,"keywords":541,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":7},"100504825","NCT05853367","Study of MK-0472 in Participants With Advanced\u002FMetastatic Solid Tumors (MK-0472-001)","A Phase 1\u002F1b Open-label, Multicenter Clinical Study of MK-0472 as Monotherapy and Combination Therapy in Participants With Advanced\u002FMetastatic Solid Tumors.","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically or cytologically confirmed solid tumor by pathology report that is advanced\u002Fmetastatic\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to study enrollment\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable (\\>4 weeks) antiretroviral therapy (ART)\n* Arm 1: Oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by a historical report or local testing (tissue or blood) and have received, or been intolerant to, all available treatment known to confer clinical benefit\n* Arm 2: Tumor types known to be sensitive to anti-programmed cell death 1 protein (PD-1)\u002Fligand 1 (L1) therapies are eligible. Tumor types permitted include: melanoma, non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR)\u002Fanaplastic lymphoma kinase (ALK)\u002FROS1 mutations, renal cell carcinoma, urothelial carcinoma, Merkel cell carcinoma, MSI-high CRC, endometrial cancer, cervical cancer, small cell lung cancer, triple negative breast cancer, esophageal cancer, gastric cancer, biliary tract cancer, hepatocellular carcinoma, head and neck squamous cancer, cutaneous squamous cancer, anal squamous cancer, and mesothelioma\n* Arm 3: Has histologically OR blood-based confirmation of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutation\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has not recovered to common terminology criteria for adverse events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study\n* Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years\n* History of hyperparathyroidism or hypercalcemia\n* Has one or more of the following ophthalmological findings\u002Fconditions: a) Intraocular pressure \\>21 mm Hg and\u002For any diagnosis of glaucoma b) Diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and c) Diagnosis of retinal degenerative disease\n* Has clinically significant cardiovascular disease\n* Bullous exfoliative skin disorders of any grade\n* Known hypersensitivity to MK-0472, MK-1084, or pembrolizumab, or any of their excipients\n* Received therapy with a proton-pump inhibitor or an H2 histamine blocker receptor antagonist within 7 days before the first scheduled day of study dosing\n* Has discontinued prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor due to an adverse event\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before first dose\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication\n* Has known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy\n* Has history of pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has active infection requiring systemic therapy\n* Has history of allogeneic tissue\u002Fsolid organ transplant\n* Have not adequately recovered from major surgery or have ongoing surgical complications",{"count":537,"type":20},178,[23],"The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced\u002Fmetastatic solid tumors.",[178,27],[542,543,544],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Death-Ligand 1 (PDL1, PD-L1)","Src Homology-2 Domain Containing Protein Tyrosine Phosphatase-2 (SHP-2)","2026-06-12",{"date":547,"type":32},"2026-06-15",{"date":549,"type":32},"2023-07-06",{"date":551,"type":20},"2028-02-12",{"name":484,"class":38},{"id":554,"slug":4,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":21,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":60},"100642689","NCT07648472","A Study of the Safety and Efficacy of the Intravenous and Intratumoral Injection of OVV-01 in Patients With Advanced Solid Tumours.","A Single-Arm, Open-Label, Dose Escalation Phase I Study of OVV-01 Intravenous and Intratumoral Injection to Evaluate the Safety, Tolerability, and Preliminary Efficacy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Be willing to sign the ICF, be able to understand the study, and be willing to follow the protocol and complete all the study procedures;\n2. Males or females aged ≥18 years when signing the ICF;\n3. Patients with advanced solid tumors (including but not limited to melanoma, squamous cell carcinoma of head and neck, cervix carcinoma, bone sarcoma, nasopharyngeal cancer, breast cancer, lung cancer, colorectal cancer, hepatic cancer, and gastric cancer) as histopathologically or cytologically confirmed by primary lesions and\u002For metastases; Patients with unresectable locally advanced disease will be included, while patients with resectable disease will be excluded.\n4. Patients who experienced treatment failure to standard of care, have no available standard of care, or are not suitable for standard of care due to medical reasons. Patients need to have progressed on at least two lines of standard of care therapy including but not limited to targeted therapy. For example, patients with metastatic or unresectable advanced melanoma who experienced treatment failure to standard of care such as anti-PD-1 antibody (patients harboring BRAF mutations who experienced treatment failure to BRAF and MEK inhibitors); patients with recurrent or metastatic advanced squamous cell carcinoma of head and neck who may have experienced standard treatment failure approved to anti-PD-1 monoclonal antibody and platinum-based chemotherapy; patients with recurrent or metastatic osteosarcoma who experienced treatment failure to chemotherapy drugs (including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, etc.); patients with colorectal cancer who have received standard of care fluoropyrimidine, oxaliplatin, Bevacizumab, and irinotecan-based chemotherapy, patients with wild-type KRAS who have received anti-EGFR, and patients with microsatellite instability-high disease who have received at least one prior immune checkpoint inhibitor; patients with breast cancer (including HR positive, HER2 +, and triple negative breast cancer) who have received at least 2 prior lines which should include taxane and\u002For anthracycline-based therapy where appropriate and an approved checkpoint inhibitor;\n5. Patients with at least one measurable lesion per RECIST v1.1, i.e., the length of non-lymph node lesion ≥10 mm or the short diameter of lymph node lesion ≥15 mm according to computed tomography (CT) or magnetic resonance imaging (MRI); The patient should also have injected tumor lesions for Part 2, including cutaneous or subcutaneous visible nodal lesions or lesions palpable deemed injectable, and hepatic lesions or non-subcutaneous lymph nodes such as retroperitoneal. These lesions should be deemed feasible for injection either directly (palpable subcutaneous tumors) by a qualified investigator or under CT or ultrasound guidance (based on size, location, and visibility); All injected tumors should be \\> 1 cm in size;\n6. Patients with an ECOG score of 0-1 and an expected survival of at least 12 weeks;\n7. Patients with adequate organ and hematopoietic function:\n\n   ANC ≥1.5×10 9\u002FL; Platelet count ≥75×10 9\u002FL (no platelet transfusion or thrombopoietin \\[TPO\\] within 2 weeks prior to the first dose); Haemoglobin ≥90 g\u002FL (no blood transfusion within 2 weeks); Serum creatinine ≤1.5×ULN or endogenous creatinine clearance (CCr) ≥50 mL\u002Fmin; AST and ALT ≤3.0×ULN; AST and ALT ≤5×ULN for patients with liver metastases; Serum TBIL ≤2×ULN; International normalized ratio (INR) ≤1.5×ULN or activated partial thromboplastin time (APTT) ≤1.5×ULN;\n8. Female patients of childbearing potential must have a negative pregnancy test result within 7 days prior to the study treatment;\n9. Male patients of reproductive potential and female patients of childbearing potential must agree to use a reliable contraceptive method during the study and at least 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with known brain metastases and\u002For clinically suspected brain metastases (however, patients with asymptomatic brain metastases or who have been clinically stable for more than 3 months after local treatment can be enrolled);\n2. Patients who received radiotherapy for the target lesion in the past 2 months;\n3. Patients with other active malignancies in the past 5 years shall be excluded, with the exceptions for those who are completely cured and do not require follow-up treatment, and those with study indications;\n4. The longest diameter of the injected lesion is \\>100 mm for Part 2;\n5. Patients participated (in the past 4 weeks) or are participating in clinical studies of the other drugs or medical devices;\n6. Patients who plan to receive or received tissue or organ transplant;\n7. Patients with human immunodeficiency virus (HIV) infection and acquired immune deficiency (AID)-related opportunistic infection within 12 months, or CD4+ T-cell (CD4+) count \\\u003C350 cells\u002FuL; patients with positive results for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb), and a hepatitis B virus deoxyribonucleic acid (HBV-DNA) level higher than the lower limit of detection at screening; patients with positive result for hepatitis C virus (HCV) antibody and a hepatitis C virus ribonucleic acid (HCV-RNA) level higher than the lower limit of detection at screening; patients with positive serology result for treponema pallidum;\n8. Patients requiring antivirals during the study or those who are within 5 half-lives of antivirals at the time of the first dose of the study drug;\n9. Patients requiring therapeutic anticoagulation during the study;\n10. Patients with uncontrolled Grade ≥3 active infection and significant clinical relevance per CTCAE v5.0;\n11. Patients who received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor drugs within 4 weeks prior to the first dose; small molecule targeted therapy and oral dose of fluorouracils within 2 weeks or 5 half-lives (whichever longer) prior to the first dose; Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 2 weeks prior to the first dose; nitrosourea or mitomycin C within 6 weeks prior to the first dose; however, patients who received palliative radiotherapy for non-target lesions are allowed (≥2 weeks prior to the first dose);\n12. Uncontrolled hypertension, pulmonary arterial hypertension or angina unstable; myocardial infarction, bypass or stent surgery within 6 months prior to the first dose; history of Grade 3-4 chronic heart failure according to New York Heart Association (NYHA) criteria; serious arrhythmia requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia that have no effect on the study as assessed by the investigator), including QTcF ≥450 ms for males and ≥470 ms for females (calculated by Fridericia's formula); cerebrovascular accident (CVA) or transient ischaemic attack (TIA) within 6 months prior to enrollment;\n13. Patients with active autoimmune disease or history of autoimmune disease that may relapse, however, patients with the following diseases are not excluded and may be further screened:\n\n    Type 1 diabetes mellitus; Thyroid function decreased (if controlled with hormone replacement therapy only); Controlled coeliac disease; Skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia); Any other disease that does not recur without an external triggering factor;\n14. Patients who require systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose or during the study, with the following exceptions:\n\n    Adrenaline replacement steroids (prednisone ≤10 mg\u002Fday or equivalent); Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; Prophylactic short-term (≤7 days) use of corticosteroids (e.g., allergy to contrast media) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reactions caused by contact allergens);\n15. Patients have tumors positioned in high-risk locations, including mucosal regions or proximity airways, major blood vessels, or spinal cord that may cause occlusion or compression upon tumor swelling or erosion into major vessels due to necrosis or encapsulated major vascular structures like the carotid artery, or adjacent to important neurovascular structures, or other tumors considered unsuitable for intratumoral injection (Part 2);\n16. Patients requiring any live vaccines during the screening and treatment periods;\n17. Patients who are allergic to any components of the study drug, immunotherapy or related drugs;\n18. Patients who have mental illness, alcoholism, failure to quit smoking, drug use or drug abuse;\n19. Pregnant or breast-feeding women;\n20. Patients with toxicities (except for alopecia) caused by prior anti-tumor therapies not yet recovered to CTCAE v5.0 Grade 1;\n21. Patients with serious, uncontrolled diseases or other conditions that may affect the study treatment and are not suitable for this study as assessed by the investigator;\n22. Patients with other conditions that are not suitable for enrollment in the opinion of the investigator.",{"count":560,"type":20},18,[23],"This is an open-label, single-arm, dose escalation clinical study to evaluate the safety and preliminary efficacy of OVV-01 Injection in patients with advanced solid tumors, following both intravenous (iv.) and intratumoral (it.) injections. This study consists of two parts: Part 1 is a dose escalation study of iv. administration; Part 2 is a dose escalation study of iv. and it. administration.",[27],[565,566],"OVV-01","VSV","2026-06-11",{"date":547,"type":32},{"date":570,"type":32},"2026-04-21",{"date":572,"type":20},"2027-04-20",{"name":574,"class":38},"Joint Biosciences Ltd.",{"id":576,"slug":4,"hasResults":11,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":581,"enrollmentInfo":582,"targetDuration":4,"studyType":21,"phases":584,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":60},"100594464","NCT07019779","Study of CM518D1 in Patients With Advanced Solid Tumors","A Multicenter, Open-Label, Phase I\u002FII Clinical Study to Evaluate CM518D1 in the Treatment of Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Male or female ≥ 18 and ≤75 years of age.\n* 2\\. Subjects with histologically or cytologically confirmed advanced solid tumors.\n* 3\\. At least one measurable lesion according to RECIST v1.1.\n* 4\\. Expected survival time ≥ 3 months as judged by the Investigator.\n\nExclusion Criteria:\n\n* 1\\. Subjects who have received any chemotherapy or any drug therapy for antitumor treatment including monoclonal antibodies, targeted therapy, radioimmunoconjugates, or Antibody-Drug Conjugates(ADCs), or any investigational product therapy for anti-tumor therapy within 28 days prior to the first dose or within 5 half-lives (whichever is shorter).\n* 2\\. Subjects who have received major surgery within 28 days prior to the first dose.\n* 3\\. Subjects who have received radiotherapy within 21 days prior to the first dose.\n* 4\\. Subjects who have received systemic glucocorticoid therapy (more than 10 mg of prednisone or equivalent daily) or other forms of immunosuppressive therapy within 7 days prior to the first dose.\n* 5\\. Subjects who have received any CDH17-targeted therapy.\n* 6\\. History of other malignancies within 5 years prior to the first dose, excluding cured basal or squamous cell carcinoma of skin, carcinoma cervix in situ, or breast ductal carcinoma in situ.\n* 7\\. Hypersensitivity to the investigational drug or its excipients.\n* 8\\. Pregnant or lactating female patients.","75 Years",{"count":583,"type":20},434,[23,24],"This is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors.",[27],{"date":547,"type":32},{"date":589,"type":32},"2025-06-27",{"date":591,"type":20},"2029-12-31",{"name":593,"class":38},"Keymed Biosciences Co.Ltd",{"id":595,"slug":4,"hasResults":11,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":21,"phases":602,"briefSummary":603,"conditions":604,"keywords":605,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":620},"100620645","NCT07360314","Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors","A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants have histologically proven advanced solid tumors with known prevalent and high Ly6E expression, Disease characteristic: Participants should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or for which no standard therapy is judged appropriate by the Investigator.\n\nFor each tumor type, participants have received prior lines of therapy, where locally available:\n\n* Non-small cell lung cancer (nonsquamous or squamous)\n* Triple-negative breast cancer\n* Squamous cell carcinoma of head and neck\n* Pancreatic ductal adenocarcinoma\n* Gastric cancer\n* Epithelial ovarian cancer\n\n  * Participants with ECOG Performance Status (ECOG) less than and equal to (\\\u003C=) 1\n  * Participants must have blood, liver, and kidney function within safe levels.\n  * Other protocol defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Participant has a history of another malignancy 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\u002Fhyperplasia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years before the date of enrollment). History of hematopoietic allogenic transplantation.\n* Participants with known brain metastases, except those meeting both of the following criteria:\n\n  1. All brain metastases have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment.\n  2. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable).\n* Participants with diarrhea (liquid stool) or ileus Grade more than (\\>) 1 within 1 week of Cycle1Day1.\n* Participants with active chronic inflammatory bowel disease and\u002For bowel obstruction.\n* Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day1.\n* Other protocol defined exclusion criteria may apply.",{"count":601,"type":20},138,[23],"The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in participants with locally advanced or metastatic solid tumors with known Ly6E expression, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), epithelial ovarian carcinoma (EOC), squamous cell carcinoma of the head and neck (SCCHN), pancreatic ductal adenocarcinoma (PDAC), and gastric cancer (GC).",[27],[606,607,180,608,609,337,334,610,611],"Ly6E expression","Topoisomerase I inhibitor (TOP1i)","Breast cancer","Gastric cancer","Pancreatic ductal adenocarcinoma","Systemic antibody-drug conjugate therapy (ADC) therapy","2026-06-10",{"date":567,"type":32},{"date":615,"type":32},"2026-02-13",{"date":617,"type":20},"2029-03-28",{"name":619,"class":38},"EMD Serono Research & Development Institute, Inc.",9,""]