[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-solid-tumors":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,54,76,114,139,179,246,272,307,339,371,392,414,434,458,484,514,538,561,586,604,628,664,684,708],{"id":9,"slug":10,"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":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100623492","phase-1-study-of-rason-inhibitors-in-combination-with-ivonescimab-in-patients-with-solid-tumors-100623492",false,"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.","ALL","18 Years",{"count":19,"type":20},370,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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.",[27,28,29,30,31,32],"Advanced Solid Tumors","Metastatic Solid Tumors","Non-small Cell Lung Cancer (NSCLC)","NSCLC","Colorectal Cancer (CRC)","CRC",[27,28,34,30,35,32,36,37,38,39,40],"Non-small Cell Lung Cancer","Colorectal Cancer","RAS","NRAS","KRAS","HRAS","RAS Mutation","RECRUITING","2026-06-26",{"date":44,"type":45},"2026-06-29","ACTUAL",{"date":47,"type":45},"2026-01-30",{"date":49,"type":20},"2029-05",{"name":51,"class":52},"Revolution Medicines, Inc.","INDUSTRY",6,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100518507","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-of-ro7566802-as-a-single-agent-and-in-combination-with-atezolizumab-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100518507","NCT06031441","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase I, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Life expectancy \\>=3 months, in the investigator's judgment\n* Adequate hematologic and end-organ function\n* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care\n* Measurable disease per RECIST v1.1\n* Tumor specimen availability, for certain cohorts\n\nExclusion Criteria:\n\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to Cycle 1 Day 1, with certain exceptions\n* Active hepatitis B or C\n* Active tuberculosis\n* Positive test for human immunodeficiency virus (HIV) infection\n* Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Active or history of autoimmune disease\n* Prior allogeneic stem cell or organ transplantation\n* Uncontrolled tumor-related pain\n* Significant cardiovascular disease\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":62,"type":20},250,[23],"This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.",[66,67,28],"Locally Advanced Solid Tumors","Recurrent Solid Tumors",{"date":44,"type":45},{"date":70,"type":45},"2023-11-27",{"date":72,"type":20},"2027-12-31",{"name":74,"class":52},"Genentech, Inc.",18,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100591693","phase-1-a-study-of-eras-0015-in-patients-with-advanced-or-metastatic-solid-tumors-100591693","NCT06983743","A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors","A Phase 1 First-in-Human Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-0015 Monotherapy and in Combination in Patients Advanced Solid Tumors","AURORAS-1","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Willing and able to give written informed consent\n* Pathological documentation of tumor type and mutation prior to the first dose of study drug(s), for applicable cohorts.\n* There is no available standard systemic therapy available for the patient's tumor histology and\u002For molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy. Does not apply to newly diagnosed Pancreatic Ductal Carcinoma (PDAC) cohort.\n* Able to swallow oral medication\n* Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n* Adequate cardiovascular, hematological, liver, and renal function\n* Willing to comply with all protocol-required visits, assessments, and procedures\n\nExclusion Criteria:\n\n* Previous treatment with a RAS inhibitor\n* Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-0015\n* Received prior palliative radiation within 14 days of Cycle 1, Day 1\n* Have primary central nervous system (CNS) tumors\n* Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption\n* Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs\n* Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial","99 Years",{"count":86,"type":20},600,[23],"The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 will be given alone or in combination with other treatments.",[28],[91,92,93,94,95,96,97,98,99,100,101,35,102,103,104],"Solid Tumor","Advanced Solid Tumor","solid malignancies","Targeted therapy","Molecular alterations","pembrolizumab","KEYTRUDA ®","panitumumab","Vectibix","Metastatic Solid Tumor","Neoplasms","Non-small cell lung cancer (NSCLC)","Newly diagnosed Pancreatic Ductal Adenocarcinoma","NSCLC patients previously treated with a KRAS G12c inhibitor","2026-06-23",{"date":42,"type":45},{"date":108,"type":45},"2025-06-05",{"date":110,"type":20},"2028-12-01",{"name":112,"class":52},"Erasca, Inc.",7,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":5},"100504825","phase-1-study-of-mk-0472-in-participants-with-advancedmetastatic-solid-tumors-mk-0472-001-100504825","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":122,"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.",[28,27],[127,128,129],"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":132,"type":45},"2026-06-15",{"date":134,"type":45},"2023-07-06",{"date":136,"type":20},"2028-02-12",{"name":138,"class":52},"Merck Sharp & Dohme LLC",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100611245","phase-1-adcx-020-for-the-treatment-of-patients-with-locally-advanced-or-metastatic-cancers-100611245","NCT07238075","ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers","A First-in-human, Multicenter Dose Escalation and Multiple Cohort Expansion Phase 1a\u002Fb Study to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ADCX-020 in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Male and female participants ≥ 18 years of age\n* Ph1a: Locally advanced or metastatic solid tumor relapsed or PD following local standard treatments, for which no standard treatment is available\n* Ph1b: Eligible patients should have only received prior lines of systemic therapy according to SoC in the advanced\u002Fmetastatic setting (not counting neoadjuvant\u002Fadjuvant treatment if completed \\>6 months prior to recurrence)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Radiologically measurable disease by RECIST v1.1\n* Mandatory adequate tumor tissue sample available\n* Must have recovered from all clinically relevant toxicities from previous cancer therapies (to at least Grade 1, except for alopecia)\n\nExclusion Criteria:\n\n* Known allergies\u002Fhypersensitivity\u002Fintolerance to or contraindication to exatecan, or any excipient\n* Phase 1b: Prior antibody drug conjugate exposure with a topoisomerase 1 inhibitor payload\n* Uncontrolled or significant cardiac disease including left ventricular ejection fraction (LVEF) \\\u003C50%, myocardial infarction or uncontrolled\u002Funstable angina\n* Has clinically active central nervous system (CNS) metastases\n* Has a history of lung fibrosis or non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Active corneal disease, or history of corneal disease within 12 months prior to enrollment\n* Other unacceptable abnormalities, medications or procedures as defined by protocol",{"count":147,"type":20},290,[23],"The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors. ADCX-020 is an investigational anticancer therapy called antibody drug conjugate.\n\nThis study is set up in multiple parts. In the first part of the study, participants receive increasing doses of ADCX-020. Then 2 or more doses will be assessed to identify the optimal dose. This optimal dose is subsequently evaluated for effect on different cancer types.",[151,152,28],"Advanced Malignancy","Advanced Solid Cancers",[154,155,156,101,157,158,159,160,161,162,163,164,165,166,167,168],"Antibody Drug Conjugate","Antineoplastic Agents","Monoclonal Antibodies","Response Evaluation Criteria in Solid Tumors (RECIST)","Phase 1 clinical trial","Maximum Tolerated Dose","Open-Label Trials","Multicenter Study","Pharmacokinetics","Pharmacodynamics","Drug-Related Side Effects and Adverse Reactions","Dose-Response Relationship, Drug","Adults","Progression-Free Survival \u002F Overall Survival","Overall response rate","2026-06-05",{"date":171,"type":45},"2026-06-08",{"date":173,"type":45},"2026-02-23",{"date":175,"type":20},"2029-11-30",{"name":177,"class":52},"Adcytherix SAS",9,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":187,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100292920","phase-1-a-study-of-repotrectinib-tpx-0005-in-patients-with-advanced-solid-tumors-harboring-alk-ros1-or-ntrk1-3-rearrangements-100292920","NCT03093116","A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements","A Phase 1\u002F2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)","TRIDENT-1","PHASE 1\n\nKey Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) (Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.\n2. ECOG PS 0-1.\n3. Age ≥18 (or age ≥ 20 of age as required by local regulation).\n4. Capability to swallow capsules intact (without chewing, crushing, or opening).\n5. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed.\n6. Prior cytotoxic chemotherapy is allowed.\n7. Prior immunotherapy is allowed.\n8. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.\n9. Patients with asymptomatic CNS metastases (treated or untreated) and\u002For asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria.\n10. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500\u002Fmm3 (1.5 × 109\u002FL); Platelets (PLTs) ≥100,000\u002Fmm3 (100 × 109\u002FL); Hemoglobin ≥ 9.0 g\u002FdL transfusions are allowed; Serum creatinine or creatinine clearance Within normal limits or \\> 40 mL\u002Fmin; Total serum bilirubin \\\u003C 1.5 × ULN; Liver transaminases (ASTs\u002FALTs) \\\u003C 2.5 × ULN; \\\u003C 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); \\\u003C 2.5 × ULN; \\\u003C 5 × ULN if liver and\u002For bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation\n11. Life expectancy ≥ 3 months.\n\nPHASE 2 Key Inclusion Criteria\n\n1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or NTRK1-3 gene fusion.\n2. Subject must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing using either:\n\n   1. a next-generation sequencing (NGS) or quantitative polymerase chain reaction (qPCR) test will be accepted to determine molecular eligibility.\n\n      • Adequate tumor tissue needs to be sent to the Sponsor designated central diagnostic laboratory for retrospective confirmation by a central diagnostic laboratory test selected by the Sponsor.\n\n      OR\n   2. a fluorescence in situ hybridization (FISH) test AND prospective confirmation of fusion status by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment will be accepted to determine molecular eligibility.\n\n      * Adequate tumor tissue must be sent to the Sponsor designated central diagnostic laboratory for prospective confirmation by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.\n4. Age ≥12 (or age ≥ 20 as required by local regulation).\n5. Willing and able to provide written institutional review board (IRB)\u002Finstitutional ethics committee-approved Informed Consent or an Assent signed by a parent or legal guardian for subjects age 12 to 17.\n6. At least 1 measurable target lesion according to RECIST (v1.1) prospectively confirmed by Blinded Independent Central Radiology Review (BICR), selected by Sponsor, PRIOR to enrollment. Subjects with CNS-only measurable disease ≥10 mm as defined by RECIST (v1.1) are eligible.\n7. Subjects with advanced solid tumors harboring ROS1, NTRK1, NTRK2, or NTRK3 rearrangement will be assigned into 6 distinct expansion (EXP) cohorts provided all inclusion and exclusion criteria are met.\n\n   i. EXP-1: ROS1 TKI-naïve ROS1+ NSCLC ii. EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC iii. EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) iv. EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) v. EXP-5: TRK TKI-naïve NTRK+ solid tumors vi. EXP-6: TRK TKI-pretreated NTRK+ solid tumors\n8. Subjects with asymptomatic CNS metastases (treated or untreated) and\u002For asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria.\n9. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500\u002Fmm3 (1.5 × 109\u002FL); Platelets (PLTs) ≥100,000\u002Fmm3 (100 × 109\u002FL); Hemoglobin ≥ 9.0 g\u002FdL transfusions are allowed; Serum creatinine or creatinine clearance \\> 40 mL\u002Fmin; Total serum bilirubin \\\u003C 1.5 × ULN; Liver transaminases (ASTs\u002FALTs) \\\u003C 2.5 × ULN; \\\u003C 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); \\\u003C 2.5 × ULN; \\\u003C 5 × ULN if liver and\u002For bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation\n10. Life expectancy ≥ 3 months.\n\nKey Exclusion Criteria PHASE 1 and PHASE 2\n\n1. Concurrent participation in another therapeutic clinical trial.\n2. Symptomatic brain metastases or leptomeningeal involvement.\n3. History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 2 years.\n4. Major surgery within 4 weeks of start of repotrectinib treatment. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation (≤10 fractions) must have been completed at least 48 hours prior to study entry\n5. Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2\n6. Any of the following cardiac criteria:\n\n   Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTcF) \\> 470 msec obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\> 250 msec) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval.\n7. Known active infections (bacterial, fungal, viral including HIV positivity).\n8. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.\n9. Peripheral neuropathy of CTCAE ≥grade 2.\n10. History of extensive, disseminated, bilateral, or presence of CTCAE grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis. Subjects with history of prior radiation pneumonitis are not excluded.","12 Years",{"count":189,"type":20},500,[23,24],"Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.\n\nMidazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction.\n\nPhase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.",[66,28],[194,195,196,197,198,199,30,200,201,202,203,204,205,206,207,101,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,185,230,231,232,233,234,235],"ALK","ROS1","NTRK","Sarcoma","Lung Neoplasms","Carcinoma, NSCL","Non Small Cell Lung","Thyroid Disease","Colonic Neoplasms","Thyroid Neoplasms","Carcinoma, Neuroendocrine","Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms by Site","Lung Disease","Respiratory Tract Disease","Carcinoma, Bronchogenic","Bronchial Neoplasms","Endocrine System Disease","Colorectol Neoplasms","Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Gastrointestinal Disease","Colonic Disease","Intestinal Disease","Endocrine Gland Neoplasms","Head and Neck Neoplasms","Neuroendocrine Tumors","Neuroectodermal Tumors","Neoplasms, Germ Cell and Embryonal","Neoplasms by Histologic Type","Adenocarcinoma","Non Small Cell Lung Cancer","Solid Tumors","Rearrangements","TKI","TKI naive","TKI pretreated","Anti-tumor activity","Repotrectinib","Advanced Solid Malignancies","2026-05-26",{"date":238,"type":45},"2026-05-27",{"date":240,"type":45},"2017-03-07",{"date":242,"type":20},"2028-02-29",{"name":244,"class":52},"Turning Point Therapeutics, Inc.",165,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":21,"phases":255,"briefSummary":256,"conditions":257,"keywords":261,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":271},"100607819","phase-1-beacon-1-study-of-avzo-103-as-a-single-agent-and-in-combination-therapy-in-patients-with-locally-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-avzo-103-1001-100607819","NCT07193511","BEACON-1: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001)","A Phase 1\u002F2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-103, a Nectin4\u002FTrop2 ADC, as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","Key Inclusion Criteria:\n\n* Patient must be an adult, 18 years of age and older with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \\> 3 months.\n* Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic malignancies for tumor types of preferred indications:\n\n  o Locally advanced or metastatic urothelial cancer and other solid tumors (as specified in the protocol).\n* Measurable disease as assessed by Investigator using RECIST v1.1.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable.\n* Other protocol-defined Inclusion criteria apply.\n\nKey Exclusion Criteria:\n\n* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.\n* Prior Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis.\n* History of drug-induced interstitial lung disease (ILD).\n* History of any serious cardiovascular condition.\n* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.\n* History of allogenic stem cell or solid organ transplant.\n* Other protocol-defined Exclusion criteria apply.",{"count":254,"type":20},355,[23,24],"This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-103 when administered intravenously as a monotherapy and in combination therapy to patients with locally advanced or metastatic urothelial cancer or other solid tumors.",[258,259,28,260],"Solid Tumor Cancer","Locally Advanced","Urothelial Cancer",[228,262,259,260],"Metastatic","2026-05-21",{"date":236,"type":45},{"date":266,"type":45},"2025-10-02",{"date":268,"type":20},"2030-09",{"name":270,"class":52},"Avenzo Therapeutics, Inc.",10,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100610198","the-sarah-nanotechnology-system-for-treatment-of-advanced-metastatic-solid-tumors-using-hyperthermia-100610198","NCT07224464","The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia.","Open Label Feasibility Dose Escalation Study to Evaluate the Safety of Sarah Nanotechnology System, With Alternating Magnetic Field (AMF) Application in Patients With Advanced Metastatic Solid Tumors.","Inclusion Criteria:\n\n1. Life expectancy of at least 90 days.\n2. Histologically confirmed advanced metastatic solid tumors located between the thoracic inlet and the pelvic floor, that have progressed on or after standard therapy and are ineligible for surgical resection or local therapies.\n3. Must have measurable disease according to RECIST 1.1.\n4. Locally advanced or metastatic disease which is not amenable to curative therapy and has progressed on or is intolerant to standard available therapy as deemed by the investigator.\n5. There must be resolution of all systemic treatment-related adverse events. At least 14 days must have elapsed since the last systemic or radiotherapy treatment before screening visit.\n6. Documented progressive disease confirmed by either CT (chest and abdomen), MRI or PET\u002FCT scan since patient's last cancer therapy.\n7. No prior history of brain metastasis confirmed by CT or MRI within 30 days prior to treatment.\n8. Treatment planning CT scan performed within 14 days prior to study treatment.\n9. Age ≥18 years.\n10. Rib cage circumference ≤ 90 cm.\n11. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n12. Patients should have sufficient organ and bone marrow function on screening day and on procedure day as defined below:\n\n    Leukocytes ≥3,000\u002FmcL Absolute neutrophil count ≥1,500\u002FmcL Platelets ≥100,000\u002FmcL Total bilirubin ≤ 2.5 x limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤5 x institutional ULN Creatinine Glomerular filtration rate (GFR) ≥50 ml\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal.\n13. Ability to provide written informed consent document.\n14. Confirmation that patient has no electronic or electronically conductive implants or metals:\n\n    * Via a review of the CT scan\n    * Metal questionnaire filled in by patients\n\nExclusion Criteria:\n\n1. Received chemotherapy, radiotherapy or hormonal therapy within 14 days (before screening).\n2. Received immunotherapy\u002Fbiological therapy or any other investigational agent in the last 21 days (before screening).\n3. Not yet recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1).\n4. Presence of brain metastases or prior history of brain metastases (if no prior history, confirmed by CT or MRI within 30 days prior to treatment).\n5. Known history of allergic reactions attributed to compounds of similar chemical or biological composition (For example: PEG 20,000 Dalton).\n6. Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, ischemia, or psychiatric illness) that in the opinion of the investigator would either limit compliance with study requirements or put participant at risk.\n7. Pregnant and\u002For breastfeeding.\n8. Unwilling to be abstinent or on contraception for up to 30 days after the last study treatment.\n9. Presence of electronic or electronically conductive implants or metals in body (verified by screening CT and metal questionnaire).\n10. Rib cage circumference over 90 cm.\n11. Unable to provide written informed consent.\n12. Unable to lay down with hands extended over head.",{"count":280,"type":20},12,[282],"NA","This is a sequential, dose-escalation, non-randomized, prospective, early feasibility trial. The goal of this clinical trial is to gather information on the safety and the recommended dose of the Sarah Nanotechnology System. Eligible participants have stage 4 metastatic solid tumor(s), that is(are) not responding to conventional treatment or have declined standard treatment options.\n\nThe main question it aims to answer is:\n\n• What is the safety profile of the Sarah Nanotechnology System and which field strength and time of irradiation are safe for people?\n\nStudy participation involves:\n\n* One intravenous injection (through a vein in the arm) of a solution that contains tiny particles (nanoparticles) containing iron oxide. The nanoparticles are delivered to the tumor(s) through blood circulation.\n* About 4 hours after injection of the nanoparticles, participants are placed inside a machine (magnetic field system) where the upper torso will be exposed to low frequency (\\~300 kHz) alternating magnetic field (AMF) radiation. This type of radiation, unlike CT or X- rays, is non-ionizing. Non-ionizing means radiation that lacks the energy to remove electrons from an atom. Examples of devices that produce non-ionizing radiation are MRI machines, cell phones, Wi-Fi, microwave ovens, and sunlight.\n\nThe AMF heats up the iron oxide core in the nanoparticles, due to their magnetic properties, which in turn causes the temperature to increase within the tumor(s). Because cancer cells are more sensitive to heat than normal cells, the heat will damage the cancer cells potentially without harming the surrounding healthy tissues.\n\n* During the treatment participants are covered by a cooling blanket to control body temperature, which will be monitored continuously throughout the procedure.\n* Participants are followed up at 1 week and 1 month, and up to 5 years after the one-time treatment.",[28,285],"Stage 4 Cancer",[287,288,289,290,291,292,293,294,295,296,28],"Advanced metastatic solid tumors","Stage 4 cancer","Stage 4 liver cancer","Stage 4 ovarian cancer","Stage 4 colon cancer","Stage 4 breast cancer","Stage 4 lung cancer","Stage 4 cervical cancer","Stage 4 cholangiocarcinoma","Hyperthermia","2026-05-13",{"date":299,"type":45},"2026-05-15",{"date":301,"type":45},"2025-12-16",{"date":303,"type":20},"2030-12",{"name":305,"class":52},"New Phase Ltd.",1,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":21,"phases":317,"briefSummary":318,"conditions":319,"keywords":324,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":338,"locationsCount":75},"100595891","phase-1-aventine-1-study-of-avzo-1418-as-a-single-agent-and-in-combination-therapy-in-patients-with-locally-advanced-or-metastatic-solid-tumors-avzo-1418-1001-100595891","NCT07038343","AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)","A Phase 1\u002F2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria\n\n* Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \\> 3 months.\n* Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic malignancies for tumor types of preferred indications:\n\n  o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol).\n* Measurable disease as assessed by Investigator using RECIST v1.1.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable.\n* Other protocol-defined Inclusion criteria apply.\n\nKey Exclusion Criteria\n\n* Uncontrolled hypertension.\n* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.\n* History of drug-induced interstitial lung disease (ILD).\n* History of any serious cardiovascular condition.\n* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.\n* History of a solid organ transplant.\n* Other protocol-defined Exclusion criteria apply.","75 Years",{"count":316,"type":20},480,[23,24],"This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.",[258,259,28,320,321,322,260,323],"Lung Cancers","Epithelial Tumor","Biliary Tract Cancer (BTC)","Nasopharyngeal Cancers",[228,262,259,325,326,327,260,328,329,330,331,332,30],"Lung Cancer","Epithelial Solid Tumors","Biliary Tract Cancer","SCLC","HER3","EGFR","BTC","Small Cell Lung Cancer","2026-05-11",{"date":297,"type":45},{"date":336,"type":45},"2025-06-04",{"date":303,"type":20},{"name":270,"class":52},{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":314,"enrollmentInfo":347,"targetDuration":4,"studyType":21,"phases":349,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":306},"100638267","phase-1-phase-12-study-of-eb-nk-301-allogeneic-trop2-car-nk-cells-in-advanced-trop2-expressing-solid-tumors-100638267","NCT07589530","Phase 1\u002F2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors","A Phase 1\u002F2, Open-Label, Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of EB-NK-301 (Allogeneic TROP2-Targeted CAR NK Cells) Following Lymphodepleting Chemotherapy in Adults With Advanced or Metastatic TROP2-Expressing Solid Tumors","SOLID-NK","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of informed consent.\n* Histologically or cytologically confirmed advanced or metastatic solid tumor with documented TROP2 expression (per local testing or central confirmation).\n* Disease progression on, intolerance to, or ineligibility for available standard therapy.\n* At least one measurable lesion per RECIST 1.1.\n* ECOG performance status 0 to 1.\n* Adequate organ function (hematologic, renal, hepatic) within protocol-defined limits.\n* Life expectancy ≥ 12 weeks.\n* Willingness to use effective contraception during study participation and for a protocol-defined period after last infusion (if of childbearing potential).\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) metastases or leptomeningeal disease (unless treated and clinically stable for ≥ 4 weeks).\n* Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.\n* Uncontrolled active infection, including uncontrolled hepatitis B, hepatitis C, or HIV infection.\n* Active autoimmune disease requiring systemic immunosuppression.\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke within 6 months, uncontrolled arrhythmia).\n* Receipt of another investigational agent within 2 weeks (or 5 half-lives, whichever is longer) prior to lymphodepleting chemotherapy.\n* Prior gene-modified cellular therapy within 3 months prior to enrollment.\n* Systemic corticosteroid therapy \\> 10 mg\u002Fday prednisone equivalent within 7 days prior to lymphodepletion (excluding physiologic replacement).\n* Pregnant or breastfeeding.",{"count":348,"type":20},60,[23,24],"study evaluates EB-NK-301, an investigational off-the-shelf allogeneic CAR-NK cell product targeting TROP2, in adults with advanced or metastatic solid tumors that express TROP2 and have progressed after standard therapy.\n\nThe primary goals are to assess safety and tolerability, identify dose-limiting toxicities (DLTs), and determine a recommended Phase 2 dose (RP2D). Secondary goals include preliminary anti-tumor activity, persistence of infused CAR-NK cells, and exploratory immune biomarkers.",[27,28,352],"TROP2-Expressing Solid Tumors",[354,355,356,357,358,359,360,361,362],"Solid tumors","Immunotherapy","Adoptive cell therapy","Natural killer cells","NK cell therapy","CAR-NK","Dose escalation","Dose expansion","TROP2","2026-05-10",{"date":299,"type":45},{"date":366,"type":45},"2026-03-02",{"date":368,"type":20},"2028-03-17",{"name":370,"class":52},"Beijing Biotech",{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":314,"enrollmentInfo":378,"targetDuration":4,"studyType":21,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":306},"100599646","phase-1-a-study-of-skb107-in-advanced-solid-tumors-with-bone-metastases-100599646","NCT07087197","A Study of SKB107 in Advanced Solid Tumors With Bone Metastases","A Multicenter, Open-label Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Dosimetry and Efficacy of SKB107 in Subjects With Advanced Solid Tumors With Bone Metastases","Inclusion Criteria:\n\n1. The age should be between 18 years and 75 years at the time of signing the informed consent form (ICF);\n2. The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;\n3. The expected survival period should be ≥ 3 months;\n4. Phase Ia: Subjects with advanced solid tumor bone metastases diagnosed by histology or cytology; and the subjects have failed standard treatment, or have no standard treatment, or are intolerant or not applicable to standard treatment;\n5. Phase Ib: Subjects with advanced mCRPC diagnosed by histology or cytology;\n6. Before the first administration, a 99mTc-MDP bone scan diagnosed multiple bone metastases, and at least one site was confirmed by CT or MRI;\n7. Have adequate organ and bone marrow functions;\n8. For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration;\n9. The subjects voluntarily join this study, sign the informed consent form, and can comply with the visit and related procedures stipulated in the protocol.\n\nExclusion Criteria:\n\n1. The washout period before the first administration of the study drug was insufficient.\n2. Previous received similar radionuclide internal irradiation treatment.\n3. Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.\n4. Known \"super bone imaging\".\n5. Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.\n6. Any cardiovascular or cerebrovascular diseases or cardiovascular risk factors that may affect the treatment of the study drug.\n7. Poorly controlled diabetes and hypertension.\n8. The toxicity of previous anti-tumor treatment before the first administration has not recovered to ≤ 1 grade (evaluated based on NCI-CTCAE v5.0) or has not reached the level specified in the inclusion\u002Fexclusion criteria.\n9. Had other malignant tumors within 3 years before the first administration.\n10. Subjects with severe and\u002For uncontrolled concomitant diseases.\n11. Active hepatitis B or active hepatitis C.\n12. Human immunodeficiency virus (HIV) test positive or having a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection.\n13. Subjects with a history of radionuclide\u002Fradioactive drug allergy, or allergic to any component of the study formulation.\n14. During the screening process before the first administration, the condition deteriorated rapidly, such as significant changes in the investigator's assessment of physical condition, etc.\n15. Subjects participating in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an intervention study.\n16. Any unstable disease or clinical condition, or any condition that may endanger the safety of the subject or affect the subject's compliance, or any other conditions that the investigator deems inappropriate for participation in this study.",{"count":379,"type":20},90,[23],"A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of SKB107 in subjects with advanced solid tumors with bone metastases.",[28],"2026-05-05",{"date":385,"type":45},"2026-05-08",{"date":387,"type":45},"2025-08-15",{"date":389,"type":20},"2028-07-01",{"name":391,"class":52},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.",{"id":393,"slug":394,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":21,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":404,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":4},"100628500","phase-1-study-of-qls5308-in-patients-with-advanced-solid-tumors-100628500","NCT07462442","Study of QLS5308 in Patients With Advanced Solid Tumors","A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5308 Monotherapy in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1.\n* Has adequate organ function.\n* The expected survival period is ≥3 months.\n* Based on the pathological report of the most recent biopsy or other pathological specimens, advanced or metastatic solid tumors confirmed by histology or cytology are not suitable for radical treatments such as surgery and radiotherapy.\n* According to the RECIST v1.1 evaluation criteria, the participants had at least one radiologically measurable lesion.\n\nExclusion Criteria:\n\n* Prior treatment with LIV1-targeting agents, ADCs with topoisomerase 1 inhibitor (TOP1i) payloads, or other TOP1i drugs.\n* There was symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before the first use of the investigational product.\n* Active, uncontrolled bacterial, fungal or viral infections.\n* Participants with moderate to large amounts of uncontrolled pleural, pericardial, or peritoneal effusions before the first dose (those who remain stable for at least 2 weeks after drainage may be enrolled).\n* Subjects with a history of a second malignant tumor other than the target indication within 3 years prior to signing the informed consent (excluding cured basal cell skin cancer, superficial bladder cancer, carcinoma in situ of the breast, papillary thyroid carcinoma, etc.).\n* Prior to the first dose of the investigational product, all reversible toxicities from prior anti-tumor therapy (excluding alopecia and pigmentation) have not recovered to ≤ Grade 1 (as assessed by CTCAE v5.0), with the exception that peripheral neuropathy must have not recovered to ≤ Grade 2.\n* Active autoimmune disease that requires systemic treatment or has the potential to recur.",{"count":400,"type":20},192,[23],"The goal of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS5308 monotherapy in participants with Advanced Solid Tumors. This study is divided into two phases: Phase Ia is the dose escalation phase, where dose escalation of QLS5308 conducted and RP2D is explored; In the Phase Ib tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLS5308 with advanced solid tumors.",[28],"NOT_YET_RECRUITING","2026-03-05",{"date":407,"type":45},"2026-03-10",{"date":409,"type":20},"2026-03-28",{"date":411,"type":20},"2031-08",{"name":413,"class":52},"Qilu Pharmaceutical Co., Ltd.",{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":21,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":113},"100601255","phase-1-slv-324-treatment-of-metastatic-solid-tumors-100601255","NCT07108114","SLV-324 Treatment of Metastatic Solid Tumors","A Phase 1 Dose-Escalation Study of SLV-324 in Subjects With Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Men or women (as appropriate for cancer type) of age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n3. Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records.\n4. Presence of metastatic disease that has progressed during or following previous treatment.\n5. Presence of radiographically measurable disease.\n6. Prior receipt of commercially available therapies that are indicated for the subject's cancer and have demonstrated survival benefit for that indication.\n7. Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy.\n8. Availability of computed tomography (CT) or magnetic resonance imaging (MRI) of chest, abdomen, and pelvis, and\u002For fluorodeoxyglucose (FDG) positron emission tomography (PET)\u002FCT (if appropriate for tumor type) (with PET from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.\n9. Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study drug administration.\n10. Adequate hematological profile.\n11. Adequate coagulation profile.\n12. Adequate hepatic profile.\n13. Adequate renal function.\n14. Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.\n15. For female subjects of childbearing potential, a negative serum pregnancy test.\n16. For female subjects of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.\n17. For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from the start of study therapy until ≥6 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy.\n18. Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including required tumor biopsy\u002Faspirations and\u002For radiographic studies), and study restrictions.\n19. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n1. Malignancy involving the central nervous system unless brain metastases have been previously treated with radiotherapy, have been stable for ≥4 weeks, and do not require corticosteroids.\n2. Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.\n3. Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.\n4. Significant cardiovascular event or comorbidity.\n5. Significant screening ECG abnormalities.\n6. Pregnancy or breastfeeding.\n7. Major surgery within 4 weeks before the start of study therapy.\n8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.\n9. Use of a drug known to prolong the QT interval within 7 days prior to the start of study drug administration.\n10. Concurrent participation in another therapeutic or imaging clinical trial.\n11. Other conditions likely to interfere with a subject's ability to participate in the study.",{"count":422,"type":20},70,[23],"This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-324 across a range of dose levels when administered to subjects with metastatic solid tumors.",[28],"2026-02-20",{"date":173,"type":45},{"date":429,"type":45},"2025-08-25",{"date":431,"type":20},"2027-08",{"name":433,"class":52},"Solve Therapeutics",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":21,"phases":442,"briefSummary":443,"conditions":444,"keywords":445,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":306},"100609519","phase-1-phase-iaib-study-of-ckd-512-alone-and-in-combination-with-pembrolizumab-in-subjects-with-advanced-or-metastatic-solid-tumors-100609519","NCT07215637","Phase Ia\u002FIb Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors","A Multicenter, Open-label, Dose-escalation, Phase Ia\u002FIb Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CKD-512 Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumor","Inclusion Criteria:\n\n* Histologically confirmed advanced or metastatic solid tumors.\n* Progressive disease after or intolerance to standard therapy and no other effective therapeutic options available.\n* Measurable disease as defined in Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Suitable venous access for the study-required blood sampling, including PK and PD sampling.\n* Adequate clinical laboratory values and other measures\n\nExclusion Criteria:\n\n* Active disease involvement of the central nervous system.\n* Any serious or life-threatening medical condition unrelated to cancer, psychiatric illness, drug or alcohol abuse, that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.\n* Systemic anticancer treatment within the protocol-specified period prior to the first dose.\n* History of any immune-related toxicity that lead to permanent discontinuation of prior anticancer therapy\n* Radiation therapy on a limited area is allowed until 4 weeks prior to the first dose of study drug, provided that the radiated lesion is clinically stable.\n* Prior treatment with investigational agents ≤21 days before the first dose of study drug(s).",{"count":348,"type":20},[23],"The purpose of this first-in-human (FiH) study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of CKD-512 given alone and in combination with pembrolizumab in subjects with advanced or metastatic solid tumors who have failed all standard available therapy.",[27,28],[446,447,448,27,28],"A2aR","adenosine A2A receptor","CKD-512","2026-01-29",{"date":451,"type":45},"2026-02-02",{"date":453,"type":45},"2025-10-16",{"date":455,"type":20},"2027-09",{"name":457,"class":52},"Chong Kun Dang Pharmaceutical",{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":21,"phases":467,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":404,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":306},"100618595","phase-2-image-guided-125i-seed-implantation-plus-standard-systemic-therapy-for-patients-with-multiple-metastatic-lesions-100618595","NCT07333664","Image-Guided 125I Seed Implantation Plus Standard Systemic Therapy for Patients With Multiple Metastatic Lesions","Standard-of-Care Systemic Therapy With or Without Image-Guided 125I Seed Implantation in Patients With Multiple (6-10) Metastatic Lesions: A Randomized Phase 2 Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed malignant solid tumor with metastatic disease.\n* Presence of more than five and up to ten (6-10) extracranial metastatic lesions, identified on CT or PET\u002FCT imaging and assessable by RECIST version 1.1 (and\u002For PERCIST when PET imaging is used).\n* At least one metastatic lesion considered suitable for image-guided iodine-125 (125I) seed implantation according to institutional assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Adequate organ function to undergo interventional procedures and systemic therapy, as determined by institutional standards.\n* Ability to understand and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Diffuse or unstable central nervous system involvement, including leptomeningeal disease or uncontrolled\u002Fsymptomatic brain metastases requiring immediate local intervention.\n* Medical conditions that preclude safe interventional procedures, including uncontrolled infection, severe cardiopulmonary dysfunction, or other serious systemic illness, as judged by the investigator.\n* Contraindications to percutaneous implantation, such as uncorrectable coagulation disorders, high bleeding risk, lack of a safe needle path, or unacceptable risk to critical organs.\n* Pregnancy or breastfeeding.\n* Inability to provide informed consent or comply with study procedures, due to severe psychiatric illness, cognitive impairment, or other limiting conditions.\n* Any other condition that, in the investigator's judgment, would make the patient unsuitable for study participation or compromise patient safety or study integrity.",{"count":466,"type":20},120,[24],"Patients with more than five and up to ten metastatic lesions often have limited tolerance for surgery, radiotherapy, or thermal ablation because of cumulative treatment burden or expected toxicity. In this setting, systemic therapy alone frequently remains the primary treatment option.\n\nThis prospective, open-label, randomized phase 2 study evaluates whether image-guided iodine-125 (125I) seed implantation, when added to standard-of-care systemic therapy, can improve disease control compared with standard systemic therapy alone in patients with multiple metastatic lesions. Clinical outcomes including progression-free survival, overall survival, safety, and quality of life will be prospectively assessed.",[28],[471,472,473],"Multiple Metastases","lodine-125 Seed Brachytherapy","Image-Guided Therapy","2026-01-02",{"date":476,"type":45},"2026-01-12",{"date":478,"type":20},"2026-01",{"date":480,"type":20},"2028-01-01",{"name":482,"class":483},"Li Min","OTHER",{"id":485,"slug":486,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":21,"phases":492,"briefSummary":493,"conditions":494,"keywords":496,"overallStatus":404,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":4},"100616549","phase-1-rare-tumor-focused-platform-study-of-innovative-therapies-and-technologies-platform2-100616549","NCT07307053","Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2)","An Open-Label, Single-Arm, Phase I\u002FII Platform Trial of Innovative Therapies and Technologies Primarily in Rare Tumors in China (PLATFORM2) in Patients With Advanced Solid Tumors","Inclusion Criteria\n\n1. Subjects must meet all of the following inclusion criteria:\n2. Male or female subjects aged ≥16 years at the time of signing the informed consent form.\n3. Histologically or cytologically confirmed malignancy.\n4. ECOG performance status of 0-2 and an expected survival of more than 12 weeks.\n5. Presence of measurable or evaluable disease for efficacy assessment, as determined by the investigator according to the individualized criteria defined in each sub-protocol.\n6. Provision of fresh tumor biopsy tissue is recommended, obtained within 12 weeks prior to the first administration of study treatment, consisting of three core needle biopsy specimens. The biopsy tissue must not have been exposed to any antitumor therapy, systemic anti-infective treatment, or vaccination after collection. Peripheral blood samples are also recommended for molecular profiling and enrollment screening.\n7. Provision of archival formalin-fixed paraffin-embedded (FFPE) tumor tissue from the primary lesion or a metastatic lesion (excluding bone metastases and lesions previously treated with radiotherapy) obtained within the past 2 years is recommended. The required material includes 15-20 unstained slides (4-6 μm thickness), of which 5 slides should be adhesive-coated and baked. If the above requirements cannot be met, enrollment eligibility may be determined at the investigator's discretion.\n8. If pleural or peritoneal effusion is present, samples must be collected for pathological cytological examination, and provision of at least 50 mL of effusion fluid is recommended, if available.\n9. If a primary tumor biopsy specimen has been provided, and a metastatic lesion is amenable to biopsy (as judged by the investigator), tissue from the metastatic lesion should be collected for pathological examination, and fresh tissue specimens are recommended.\n10. Upon disease progression, if conditions permit (as judged by the investigator), collection of fresh tumor tissue from the same biopsy site at enrollment and\u002For from previously sampled metastatic lesions is recommended.\n11. Toxicities from prior therapies must have resolved to ≤ Grade 1 or returned to baseline, according to NCI-CTCAE version 5.0, except for alopecia.\n12. A negative pregnancy test is required for women of childbearing potential. Women not of childbearing potential are defined as those who are postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy.\n13. All enrolled subjects, regardless of sex, must agree to use effective contraception throughout the treatment period and for 8 weeks after the last dose of study treatment.\n14. Subjects must voluntarily participate, provide written informed consent, comply with the study treatment and visit schedule, and be able to cooperate with safety and efficacy assessments.\n\nExclusion Criteria\n\nSubjects meeting any of the following exclusion criteria will not be eligible for participation in this study:\n\n1. Prior treatment with any antitumor novel drug or technology of the same class as that investigated in the relevant sub-protocol of this study.\n2. Known hypersensitivity or allergy to any active component or excipient of the investigational antitumor novel drug or technology.\n3. Presence of any type of interstitial lung disease or a history of radiation pneumonitis.\n4. Failure to meet the inclusion or exclusion criteria specified in the applicable sub-protocol.\n5. Major surgery performed within 4 weeks prior to the first administration of study treatment, or surgical wounds that have not fully healed.\n6. History of hypersensitivity reactions to drugs whose chemical structures are similar to the active or inactive components of the investigational antitumor novel drug or technology, or to agents of the same class.\n7. Active infection requiring systemic therapy (e.g., antibiotics), or the presence of any of the following conditions:\n\n   * Positive human immunodeficiency virus (HIV) test or a known history of acquired immunodeficiency syndrome (AIDS);\n   * Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBsAg positivity with HBV DNA levels above the upper limit of normal (ULN), or HCV antibody positivity;\n   * Active tuberculosis, defined as a history of exposure or a positive tuberculosis test accompanied by clinical symptoms and\u002For radiographic findings.\n8. Evidence of severe or uncontrolled systemic disease, as determined by the investigator, including but not limited to severe psychiatric or neurological disorders (such as epilepsy or dementia), unstable or uncompensated respiratory, cardiovascular, hepatic, or renal disease, or uncontrolled hypertension (defined as blood pressure remaining at or above CTCAE Grade 3 despite medical treatment).\n9. Myocardial infarction, coronary artery bypass grafting, peripheral artery bypass grafting, or cerebrovascular accident occurring within 3 months prior to enrollment.\n10. History of any organ transplantation, including allogeneic hematopoietic stem cell transplantation, except for transplants not requiring immunosuppressive therapy (e.g., corneal transplantation or hair transplantation).\n11. Presence of cardiovascular disease or conditions including any of the following:\n\n    * Congestive heart failure requiring treatment, or New York Heart Association (NYHA) Class III or IV heart failure;\n    * Ventricular arrhythmias requiring antiarrhythmic therapy, or uncontrolled or unstable arrhythmias;\n    * Severe conduction abnormalities, such as second- or third-degree atrioventricular block;\n    * Angina pectoris requiring treatment;\n    * Prolonged QT interval on 12-lead electrocardiogram, defined as QTc ≥450 ms for males or ≥470 ms for females;\n    * History of congenital long QT syndrome, congenital short QT syndrome, torsades de pointes, or pre-excitation syndrome;\n    * Left ventricular ejection fraction (LVEF) \\\u003C50%, as determined by echocardiography or MUGA scan;\n    * Myocardial infarction diagnosed within the past 6 months.\n12. Inadequate bone marrow reserve or organ function, as evidenced by any of the following laboratory findings:\n\n    * Absolute neutrophil count \\\u003C1.0 × 10⁹\u002FL;\n    * Platelet count \\\u003C80 × 10⁹\u002FL (patients dependent on platelet transfusion are excluded);\n    * Hemoglobin \\\u003C90 g\u002FL;\n    * In the absence of liver metastases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5 × ULN; in the presence of liver metastases, ALT or AST \\>5 × ULN (as determined by the investigator per sub-protocol);\n    * In the absence of liver metastases, total bilirubin \\>1.5 × ULN; in patients with Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases, total bilirubin \\>3 × ULN (as determined by the investigator per sub-protocol);\n    * Serum creatinine \\>1.5 × ULN with concomitant creatinine clearance \\\u003C50 mL\u002Fmin (measured or calculated using the Cockcroft-Gault formula); creatinine clearance assessment is required only when serum creatinine exceeds 1.5 × ULN;\n    * Coagulation abnormalities, defined as INR, PT, or APTT \\>1.5 × ULN in patients not receiving anticoagulant therapy; eligibility of patients receiving anticoagulants will be determined by the investigator;\n    * Elevated creatine kinase (CK) or CK-MB above the normal range (as determined by the investigator per sub-protocol).\n13. Pregnant or breastfeeding women.\n14. Any other condition that, in the opinion of the investigator, may pose a potential risk or render the subject unsuitable for participation in this study.",{"count":86,"type":20},[23,24],"The goal of this Phase I\u002FII observational and interventional platform study is to evaluate the safety and efficacy of multiple types of innovative anti-tumor drugs and new technologies in patients with rare solid tumors. The study utilizes multi-dimensional precision screening (including WES, RNAseq, mIHC, and quantitative proteomics) to match patients with specific sub-protocols.\n\nKey questions it aims to answer:\n\nAssess the safety of innovative therapies in rare tumor populations. Evaluate the objective response rate (ORR) and other efficacy metrics. Explore biomarkers related to therapeutic efficacy. Participants: Patients with metastatic or advanced rare solid tumors who have failed standard therapy or have no standard treatment options.",[495,27,28],"Rare Malignant Neoplasm",[497,498,499,355,500,501,502,503,504],"Rare Tumors","Platform Trial","Precision Medicine","Targeted Therapy","Cell and gene therapy","Tumor vaccine","Protein drug","Oncolytic virus","2025-12-13",{"date":507,"type":45},"2025-12-29",{"date":509,"type":20},"2026-01-01",{"date":511,"type":20},"2031-01-31",{"name":513,"class":483},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":515,"slug":516,"hasResults":11,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":21,"phases":523,"briefSummary":524,"conditions":525,"keywords":526,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":537},"100503520","phase-1-a-study-to-evaluate-the-safety-of-inca33890-in-participants-with-advanced-or-metastatic-solid-tumors-100503520","NCT05836324","A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors","A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* ≥18 years old\n* Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol.\n* Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study.\n* ECOG performance status score of 0 or 1.\n* Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts.\n* Presence of measurable disease according to RECIST v1.1.\n\nExclusion Criteria:\n\n* Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years.\n* Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.\n* Has active autoimmune disease requiring systemic immunosuppression with corticosteroids.\n* Brain or CNS metastases untreated or that have progressed.\n* History of organ transplant, including allogeneic stem cell transplantation.\n* History of clinically significant or uncontrolled cardiac disease.\n* Active HBV, active HCV, or HIV positive.\n* Is on chronic systemic steroids (\\> 10 mg\u002Fday of prednisone or equivalent).\n* Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment\n* Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment.\n* Significant concurrent, uncontrolled medical condition, eg:\n\n  * Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance or history of myocarditis.\n  * Gastrointestinal: Any bowel obstruction within 60 days prior to C1D1.\n* Participants with adequate laboratory values within the protocol defined ranges.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.",{"count":522,"type":20},408,[23],"To evaluate the safety, tolerability, and DLTs and determine the MTD and\u002For RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.",[228,27,28],[228,527],"INCA33890","2025-12-11",{"date":530,"type":45},"2025-12-18",{"date":532,"type":45},"2023-07-24",{"date":534,"type":20},"2027-01-13",{"name":536,"class":52},"Incyte Corporation",36,{"id":539,"slug":540,"hasResults":11,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":21,"phases":546,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":560},"100605177","phase-1-a-study-of-ds3610a-in-participants-with-advanced-solid-tumor-100605177","NCT07159126","A Study of DS3610a in Participants With Advanced Solid Tumor","A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS3610a in Participants With Advanced Solid Tumor","Key Inclusion Criteria:\n\n* Sign and date the main ICF, prior to the start of any trial-specific procedures.\n* Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old).\n* Relapsed from, refractory to, or intolerant to appropriate therapies (eg, SoC) to provide clinical benefit for their condition as assessed by their physician and\u002For investigator.\n* Is willing and able to provide an adequate pretreatment tissue sample prior to trial intervention or archival tumor tissue sample.\n* Has measurable disease based on local CT\u002FMRI imaging as assessed by the investigator per RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention.\n\nKey Exclusion Criteria:\n\n\\*Inadequate washout period before initiation of trial intervention, defined as: Major surgery: ≤4 weeks (or ≤2 weeks for low-invasive cases) Curative radiation therapy: ≤4 weeks Chemotherapy, Ab-based anticancer therapy, immunotherapy: ≤4 weeks Small molecules (eg, tyrosine kinase inhibitors): ≤2 weeks or 5 half-lives, whichever is longer Nitrosoureas: ≤6 weeks\n\n* Has known symptomatic CNS metastases, leptomeningeal disease, or cord compression. Note: Asymptomatic or adequately treated CNS metastases are not exclusionary provided that, in the opinion of the investigator, the participant is neurologically stable. MRI\u002FCT of the brain is required for all participants during SCR Period\n* Uncontrolled or clinically significant cardiovascular disease, including the following:\n\n  1. Myocardial infarction within 6 months prior to SCR.\n  2. Uncontrolled angina pectoris within 6 months prior to SCR.\n  3. New York Heart Association (NYHA) Class III or IV CHF.\n  4. LVEF ≤50%.\n  5. QTcF interval \\>470 ms.\n* Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic events.\n* Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen) resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.",{"count":422,"type":20},[23],"This study is designed to assess the safety, tolerability, and efficacy of DS3610a, given as a single agent to participants with advanced or metastatic solid tumors.",[228,28],[550],"DS3610a","2025-12-03",{"date":553,"type":45},"2025-12-10",{"date":555,"type":45},"2025-10-09",{"date":557,"type":20},"2031-02-01",{"name":559,"class":52},"Daiichi Sankyo",2,{"id":562,"slug":563,"hasResults":11,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":567,"eligibilityCriteria":568,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":569,"targetDuration":4,"studyType":21,"phases":571,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":585},"100594626","phase-1-a-study-of-eras-4001-in-patients-with-advanced-or-metastatic-solid-tumors-100594626","NCT07021898","A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.","A Phase 1 First-in-Human Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-4001 Monotherapy and in Combination in Patients With Advanced Solid Tumors","BOREALIS-1","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Willing and able to give written informed consent\n* Pathological documentation of tumor type and mutation prior to the first dose of study drug(s)\n* There is no available standard systemic therapy available for the patient's tumor histology and\u002For molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy\n* Able to swallow oral medication\n* Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n* Adequate cardiovascular, hematological, liver, and renal function\n* Willing to comply with all protocol-required visits, assessments, and procedures\n\nExclusion Criteria:\n\n* Previous treatment with a RAS inhibitor\n* Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-4001\n* Received prior palliative radiation within 14 days of Cycle 1, Day 1\n* Have primary central nervous system (CNS) tumors\n* Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption\n* Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs\n* Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial",{"count":570,"type":20},200,[23],"The main purpose of the study is to assess whether the study drug, ERAS-4001, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain KRAS mutations. ERAS-4001 will be given alone or in combination with other treatments.",[28],[91,92,575,94,95,96,576,98,99,577,101],"Solid malignancies","Keytruda","Metastatic solid tumor","2025-12-02",{"date":551,"type":45},{"date":581,"type":45},"2025-08-06",{"date":583,"type":20},"2028-12",{"name":112,"class":52},5,{"id":587,"slug":588,"hasResults":11,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":21,"phases":594,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":404,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":603,"locationsCount":4},"100613899","phase-1-study-of-qlc5513-in-combination-with-epalolimab-tovolimab-ql1706--platinum-in-patients-with-advanced-or-metastatic-malignant-solid-tumors-100613899","NCT07272590","Study of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid Tumors","An Open, Multicenter Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid Tumors","Inclusion Criteria:\n\n1. Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1.\n2. Has adequate organ function.\n3. The expected survival period is ≥3 months.\n4. Based on the pathological report of the most recent biopsy or other pathological specimens, advanced or metastatic solid tumors confirmed by histology or cytology are not suitable for radical treatments such as surgery and radiotherapy.\n5. According to the RECIST v1.1 evaluation criteria, the participants had at least one radiologically measurable lesion.\n\nExclusion Criteria:\n\n1. Prior treatment with TROP2-targeting agents, ADCs with topoisomerase 1 inhibitor (TOP1i) payloads, or other TOP1i drugs.\n2. There was symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before the first use of the investigational product.\n3. Active, uncontrolled bacterial, fungal or viral infections.\n4. Radiotherapy with more than 25% of the bone marrow exposed within 4 weeks prior to the first use of the investigational drug; Local radiotherapy (excluding brain radiotherapy) was performed within two weeks before the first use of the investigational drug.\n5. Subjects with a history of a second malignant tumor other than the target indication within 5 years prior to signing the informed consent (excluding cured basal cell skin cancer, superficial bladder cancer, carcinoma in situ of the breast, papillary thyroid carcinoma, etc.).\n6. Prior to the first dose of the investigational product, all reversible toxicities from prior anti-tumor therapy (excluding alopecia and pigmentation) have not recovered to ≤ Grade 1 (as assessed by CTCAE v5.0), with the exception that peripheral neuropathy must have not recovered to ≤ Grade 2. History of irAEs from prior immune checkpoint inhibitor treatment that required permanent discontinuation of the immune checkpoint inhibitor.\n7. Active autoimmune disease that has required systemic treatment in the past 2 years.",{"count":147,"type":20},[23,24],"The goal of this Phase Ib\u002FII interventional study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of QLC5513 combined with QL1706± platinum in the treatment of patients with advanced or metastatic malignant solid tumors. This study is divided into two phases: Phase Ib is the combined dose escalation phase, where dose escalation of QLC5513 combined with QL1706± platinum is conducted and RP2D is explored; In the Phase II tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLC5513 combined with QL1706± platinum-based treatment in patients with advanced or metastatic malignant solid tumors.",[28],"2025-11-26",{"date":599,"type":45},"2025-12-09",{"date":601,"type":20},"2025-12-30",{"date":411,"type":20},{"name":413,"class":52},{"id":605,"slug":606,"hasResults":11,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":21,"phases":613,"briefSummary":614,"conditions":615,"keywords":616,"overallStatus":404,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":306},"100612154","phase-1-a-study-of-bpr-6023021-in-advanced-solid-tumors-with-bone-metastases-100612154","NCT07249892","A Study of BPR-6023021 in Advanced Solid Tumors With Bone Metastases","A Multicenter, Open-label Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Dosimetry and Efficacy of BPR-6023021 in Subjects With Advanced Solid Tumors With Bone Metastases.","Inclusion Criteria\n\n1. The age should be up to 18 years at the time of signing the informed consent form (ICF);\n2. The Eastern Cooperative Oncology Group (ECOG) performance status score should be ≤ 1;\n3. The expected survival period should be ≥ 3 months\n4. Phase I and phase II: Subjects with advanced solid tumor bone metastases diagnosed by histology or cytology; and the subjects have failed standard treatment, or have no standard treatment, or are intolerant or not applicable to standard treatment\n5. Before the first administration, a 99mTc-MDP bone scan diagnosed multiple bone metastases, and at least two site was confirmed by CT or MRI;\n6. Have adequate organ and bone marrow functions;\n7. For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration;\n8. The subjects voluntarily join this study, sign the informed consent form, and can comply with the visit and related procedures stipulated in the protocol.\n\nExclusion Criteria\n\n1. The washout period before the first administration of the study drug was insufficient.\n2. Previous received similar radionuclide internal irradiation treatment.\n3. Previous received or planned to receive during the study period semi-body external radiotherapy targeting bone metastases.\n4. Known \"super bone imaging\".\n5. Known spinal cord compression, or clinical imaging manifestations suggesting impending spinal cord compression.\n6. Any cardiovascular or cerebrovascular diseases or cardiovascular risk factors that may affect the treatment of the study drug.\n7. Poorly controlled diabetes and hypertension.\n8. The toxicity of previous anti-tumor treatment before the first administration has not recovered to ≤ 1 grade (evaluated based on NCI-CTCAE v5.0) or has not reached the level specified in the inclusion\u002Fexclusion criteria.\n9. Had other malignant tumors within 5 years before the first administration.\n10. Subjects with severe and\u002For uncontrolled concomitant diseases.\n11. Active hepatitis B or active hepatitis C.\n12. Human immunodeficiency virus (HIV) test positive or having a history of acquired immune deficiency syndrome (AIDS); known active syphilis infection.\n13. During the screening process before the first administration, the condition deteriorated rapidly, such as significant changes in the investigator's assessment of physical condition, etc.",{"count":612,"type":20},195,[23,24],"A multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, dosimetry and efficacy of BPR-6023021 in subjects with advanced solid tumors with bone metastases",[28],[617,27,618],"BPR-6023021","Bone Metastases","2025-11-18",{"date":621,"type":45},"2025-11-25",{"date":623,"type":20},"2025-11-19",{"date":625,"type":20},"2027-09-06",{"name":627,"class":52},"Chengdu Syncor Pharmaceutical Co., Ltd.",{"id":629,"slug":630,"hasResults":11,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":635,"enrollmentInfo":636,"targetDuration":4,"studyType":21,"phases":638,"briefSummary":639,"conditions":640,"keywords":643,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":657,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":663},"100369766","phase-1-a-study-of-repotrectinib-in-pediatric-and-young-adult-subjects-harboring-alk-ros1-or-ntrk1-3-alterations-100369766","NCT04094610","A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations","A Phase 1\u002F2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations","Key Inclusion Criteria:\n\n1. Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required.\n2. Phase 1: Age \\\u003C12 years; Phase 2: Age 12- 25 years\n3. Prior cytotoxic chemotherapy is allowed.\n4. Prior immunotherapy is allowed.\n5. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.\n6. All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.\n7. Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment.\n8. Subjects must have a Lansky (\\\u003C 16 years) or Karnofsky (≥ 16 years) score of at least 50.\n9. Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.\n10. Adequate hematologic, renal and hepatic function.\n\nPhase 2 Inclusion Criteria:\n\n1. Cohort Specific Inclusion Criteria:\n\n   * Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve;\n   * Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated;\n   * Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease.\n2. Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment.\n\nKey Exclusion Criteria (Phase 1 and Phase 2):\n\n1. Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only.\n2. Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery.\n3. Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity).\n4. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.\n5. Any of the following cardiac criteria:\n\n   * Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \\> 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value\n   * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\> 250 msec)\n   * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval\n6. Peripheral neuropathy of CTCAE ≥grade 2.\n7. Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.\n8. Any potential allergies to repotrectinib and\u002For its excipients.","25 Years",{"count":637,"type":20},75,[23,24],"Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D).\n\nPhase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.",[66,28,641,642],"Lymphoma","Primary CNS Tumors",[194,195,644,645,646,647,648,649,650,651,652,653,654,655,656],"NTRK1-3","Primary CNS tumor","anaplastic large cell lymphoma","metastatic solid tumor","advanced solid tumor","sarcoma","infantile fibrosarcoma","glioblastoma","soft tissue schwannoma","solitary fibrous tumor","glioma","inflammatory myofibroblastic tumor","pediatric",{"date":623,"type":45},{"date":659,"type":45},"2020-03-12",{"date":661,"type":20},"2027-09-30",{"name":244,"class":52},68,{"id":665,"slug":666,"hasResults":11,"nctId":667,"briefTitle":668,"officialTitle":668,"acronym":4,"eligibilityCriteria":669,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":670,"targetDuration":671,"studyType":672,"phases":4,"briefSummary":673,"conditions":674,"keywords":4,"overallStatus":404,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":306},"100596539","a-multicenter-prospective-non-interventional-real-world-study-of-iparomlimab-and-tuvonralimab-injection-ql1706-in-the-treatment-of-locally-advanced-or-metastatic-solid-tumors-100596539","NCT07046780","A Multicenter, Prospective, Non-Interventional Real-World Study of Iparomlimab and Tuvonralimab Injection (QL1706) in the Treatment of Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* 1\\) Histologically or cytologically confirmed locally advanced or metastatic solid tumors with disease progression (radiographic or clinical) after ≥1 line of prior standard therapy, unsuitable for\u002Fintolerant to standard therapy. Includes but not limited to: Gastrointestinal tumors (colorectal cancer, hepatocellular carcinoma, esophageal cancer, biliary tract cancer, pancreatic cancer, gastric cancer), Breast cancer, Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Soft tissue sarcoma;\n* 2\\) ECOG performance status 0-2;\n* 3\\) ≥1 measurable lesion per RECIST v1.1 ;\n* 4\\) Adequate organ function meeting ALL criteria below:\n\n  1. Hematology (without transfusion\u002FG-CSF support within 7 days):\n\n     Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL Platelets ≥100×10⁹\u002FL Hemoglobin ≥90 g\u002FL\n  2. Biochemistry :\n\n     Total bilirubin (TBIL) ≤2×ULN ALT\u002FAST ≤2.5×ULN (≤5×ULN if liver metastases present) Serum creatinine (Cr) ≤1.5×ULN Albumin ≥28 g\u002FL\n  3. Urinalysis :\n\n     Urine protein \\\u003C2+ (dipstick) If protein ≥2+, 24h urinary protein ≤1.0 g\n  4. Coagulation (without anticoagulants):\n\nPT\u002FAPTT\u002FINR ≤1.5×ULN\n\n* 5\\) Life expectancy ≥12 weeks;\n* 6\\) Contraception : Females of childbearing potential or males with partners of childbearing potential must use effective contraception during treatment and for 6 months post-treatment;\n* 7\\) Signed informed consent and protocol compliance.\n\nExclusion Criteria:\n\n* 1\\) Tumor-Related Conditions\n\n  1. Known CNS metastases (except those radiologically stable ≥4 weeks after radiotherapy);\n  2. Other malignancies within past 5 years, excluding:\n\n     Cured basal\u002Fsquamous cell skin cancer Localized low-risk prostate cancer Cervical\u002Fbreast carcinoma in situ\n  3. Severe bone lesions from metastatic disease, including:\n\n     Uncontrolled bone pain Pathologic fractures at critical sites (within 6 months) or impending spinal cord compression;\n  4. Uncontrolled effusions requiring recurrent drainage (pleural\u002Fpericardial\u002Fascites), per investigator assessment.\n* 2\\) Prior Anti-tumor Therapy\n\n  1. Prior systemic therapy with CTLA-4 inhibitors or other ICIs;\n  2. Any anti-tumor treatment within 4 weeks before first dose, including:\n\n     Surgery\u002Fchemotherapy\u002Fpalliative radiotherapy to non-target lesions\u002Fhormonal\u002Ftargeted\u002Fbiologic\u002Fimmunotherapy;\n  3. Treatment-related toxicities not recovered to CTCAE grade ≤1 (exceptions: alopecia\u002Fplatinum-induced neuropathy ≤ grade 2).\n* 3\\) Comorbidities \\& History\n\n  1. Arterial thromboembolism within 6 months (MI\u002Funstable angina\u002Fstroke\u002FTIA);\n  2. Symptomatic heart failure (NYHA class III-IV), unstable angina, or uncontrolled arrhythmia;\n  3. Severe pulmonary disease : ILD\u002FCOPD\u002Fsymptomatic bronchospasm;\n  4. Active uncontrolled infection (≥CTCAE grade 2), including:\n\n     HIV Active HBV (DNA ≥500 IU\u002FmL) HCV (Ab+ with detectable RNA) HBV\u002FHCV co-infection;\n  5. History of neurologic\u002Fpsychiatric disorders;\n  6. Recent or current substance abuse;\n  7. Prior allogeneic organ\u002Fhematopoietic stem cell transplantation.\n* 4\\) Hypersensitivity to study drug or its excipients.\n* 5\\) Active autoimmune disease requiring treatment or history within 2 years. Exceptions: Vitiligo\u002Falopecia\u002Fpsoriasis not needing systemic therapy Hypothyroidism managed only with hormone replacement Type 1 diabetes controlled solely with insulin.\n* 6\\) Pregnant\u002Flactating women;\n* 7\\) Any uncontrolled systemic disease increasing study risk (per investigator);\n* 8\\) Other unsuitable conditions determined by investigator.",{"count":379,"type":20},"2 Years","OBSERVATIONAL","This study is a prospective, observational, real-world, multi-center study planning to enroll 90 patients. The study will observe and document patients' actual clinical practices in receiving Iparomlimab and Tuvonralimab Injection (QL1706). The primary objectives are to evaluate the safety and effectiveness of Iparomlimab and Tuvonralimab Injection (QL1706) in treating locally advanced or metastatic solid tumors.",[258,28,259],"2025-06-23",{"date":677,"type":45},"2025-07-02",{"date":679,"type":20},"2025-07-30",{"date":681,"type":20},"2027-12-30",{"name":683,"class":483},"PENG YUAN",{"id":685,"slug":686,"hasResults":11,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":4,"eligibilityCriteria":690,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":691,"targetDuration":4,"studyType":21,"phases":693,"briefSummary":694,"conditions":695,"keywords":696,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":706,"locationsCount":306},"100575321","phase-1-dose-escalation-and-expansion-study-evaluating-odc-il2-in-adult-patients-with-advanced-or-metastatic-solid-tumors-100575321","NCT06770764","Dose Escalation and Expansion Study Evaluating ODC-IL2 in Adult Patients With Advanced or Metastatic Solid Tumors","A Phase 1\u002F1b, Multicenter, Open-label, Dose Escalation and Expansion Study Evaluating the Safety, Pharmacodynamics, and Pharmacokinetics of ODC-IL2 Administered Via Intravenous Infusion in Adult Patients With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nEach patient must meet all the following criteria to participate in the study:\n\n1. Histologically or cytologically confirmed advanced or metastatic solid tumors, for which no other standard treatment is available or appropriate, or for which the Trutino Biosciences Protocol #: TRT-ODC-IL2-001 Version: 1.0 Date: 20 September 2024 standard of care is refused by the patient due to tolerability or the Investigator believes the patient will not tolerate standard-of-care therapy\n2. Advanced or metastatic tumors measurable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria;\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n4. Life expectancy of at least 3 months;\n5. Age ≥ 18 years;\n6. Signed, written Institutional Review Board (IRB)\u002FEthics Committee (EC)-approved informed consent\n7. Acceptable liver function:\n\n   * Bilirubin ≤ 1.5 times upper limit of normal (ULN) or ≤ 5 × institutional ULN for patients who have serum bilirubin increases due to underlying Gilbert's Syndrome (familial benign unconjugated hyperbilirubinemia).\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 x ULN (if liver metastases are present, then ≤ 5 x ULN is allowed)\n8. Acceptable renal function:\n\n   • Calculated creatinine clearance ≥ 50 mL\u002Fmin using the Cockcroft-Gault equation.\n9. Acceptable hematologic status:\n\n   * Absolute neutrophil count ≥ 1500 cells\u002Fmm3\n   * Platelet count ≥ 75,000 (plt\u002Fmm3)\n   * Hemoglobin ≥ 9 g\u002FdL\n10. A negative serum pregnancy test (if a woman of childbearing potential);\n11. Women of childbearing potential (WOCBP) and men with WOCBP partners must agree to use adequate contraception (hormonal method of birth control; intrauterine devices or abstinence) prior to study entry, for the duration of study participation and for 4 months after the last dose of study drug. Should a female trial participant or a female partner of a male trial participant become pregnant or suspect she is pregnant during the study, the Investigator must be informed immediately.\n\nExclusion Criteria:\n\n1. New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG)\n2. Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\> 470 msec\n3. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n4. Known active brain metastases; patients with previously treated, clinically stable, radiologically stable brain metastases (without evidence of progression in 4 weeks) and without the requirement for treatment with corticosteroids in prior 3 weeks may be considered for enrollment after discussion with the Medical Monitor\n5. History of prior organ transplant\n6. Conditions requiring systemic treatment with corticosteroids or any other form of immunosuppressive therapy within 7 days prior to start of study drug.\n7. History of autoimmune diseases requiring systemic immunosuppressive therapy in the last 2 years\n8. Pregnant or nursing women.\n9. Treatment with radiation therapy, major surgery, chemotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C). Radiation for palliation of pain is allowed within 1 week prior to study entry, but the lesion should not be selected as a target lesion for RECIST analysis.\n10. Unwillingness or inability to comply with procedures required in this protocol\n11. Known active infection with human immunodeficiency virus (HIV), human T-cell leukemia virus, type 1 (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV)\n\n    * Patients with a history of hepatitis B or C are allowed if HBV DNA or HCV RNA are undetectable\n    * Active infection with HIV and CD4+ T-cell count \\\u003C350\u002FμL. Patients not on established anti-retroviral therapy for at least 4 weeks and having a detectable HIV viral load\n12. Serious uncontrolled nonmalignant disease (e.g., renal failure, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and\u002For the sponsor\n13. Prior treatment with an IL-2 targeted treatment, unless given as a part of a tumor infiltrating lymphocyte treatment combination;\n14. Known sensitivity to IL-2 or any of the excipients in ODC-IL2;\n15. Active treatment with heparin or heparin-related therapies, unless the patient can be transitioned to a non-heparin treatment for the clinical condition with an adequate washout prior to enrollment in the study.",{"count":692,"type":20},50,[23],"This is a first-in-human, Phase I, multicenter, open-label, dose escalation study with dose expansion to evaluate the safety and antitumor activity of ODC-IL2 in patients with advanced or metastatic solid tumors. ODC-IL2 is a conditionally activated IL-2 prodrug and will be administered as a single agent via intravenous infusion on Days 1 and 15 of a 28-day cycle. Up to approximately 50 patients will be enrolled in this study.",[27,28],[697,698],"ODC-IL2","Tumors","2025-01-07",{"date":701,"type":45},"2025-01-13",{"date":703,"type":45},"2024-12-30",{"date":705,"type":20},"2027-03",{"name":707,"class":52},"Trutino Biosciences Inc.",{"id":709,"slug":710,"hasResults":11,"nctId":711,"briefTitle":712,"officialTitle":713,"acronym":4,"eligibilityCriteria":714,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":715,"targetDuration":4,"studyType":21,"phases":717,"briefSummary":718,"conditions":719,"keywords":729,"overallStatus":404,"whyStopped":4,"lastUpdateSubmitDate":742,"lastUpdatePostDateStruct":743,"startDateStruct":745,"completionDateStruct":747,"leadSponsor":749,"locationsCount":560},"100563329","phase-1-a-parg-inhibitor-dat-2645-monotherapy-in-patients-with-advancedmetastatic-solid-tumors-harboring-brca12-loss-of-function-alterations-andor-other-defects-in-the-ddr-pathway-100563329","NCT06614751","A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced\u002FMetastatic Solid Tumors Harboring BRCA1\u002F2 Loss of Function Alterations And\u002For Other Defects in the DDR Pathway","A Phase I, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of DAT-2645 in Patients with Advanced\u002FMetastatic Solid Tumors Harboring BRCA1\u002F2 Loss of Function Alterations And\u002For Other Defects in the DNA Damage Repair Pathway","Inclusion Criteria:\n\n* Signed informed consent prior to initiation of any procedures in this study.\n* At least 18 years of age (inclusive).\n* Evidence of an DDR deficiency status in tumor tissue determined by validated testing method.\n* Patients with advanced or metastatic solid tumor who have failed standard of care therapy, or are unable to tolerate standard of care therapy, or unable to obtain\u002Funwilling to receive standard therapy. Regardless of PARP inhibitors were used or not in previous treatment.\n* At least one measurable lesion by RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0\\~2.\n* Life expectancy at least 3 months.\n* Adequate hematologic and non-hematologic function during the screening.\n* Women of childbearing potential must have a negative result of serum pregnancy test at screening.\n* Women of childbearing potential or male patients whose spouse have childbearing potential must agree to use a reliable and effective method of contraception during the study and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Patients who received systemic chemotherapy, small-molecule targeted drugs within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* Patients who received biological anti-tumor drugs (including immunotherapy, target therapy, antibody-drug conjugate \\[ADC\\]) within 4 weeks prior to the first dose of the study drug.\n* Patients who have undergone major surgery within 4 weeks prior to the first dose of study drug.\n* Patients who have received radiotherapy within 4 weeks prior to the first dose of study drug (palliative radiotherapy for non-target lesions could be acceptable if it was performed before 14 days prior to the first dose of study drug).\n* Any previous treatment with a PARG inhibitor.\n* Patients with active CNS metastases (patients with asymptomatic CNS metastases which are imaging stable and not require steroid treatment within 28 days prior to the first dose of study drug, and previous treated breast cancer brain metastasis, can only be enrolled in the Part 2 study).\n* Patients who have second primary malignant tumors within the past 3 years prior to screening, except for those who have been cured of basal cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ.\n* Patients with clinically significant cardiovascular or cerebrovascular diseases.\n* Active uncontrolled infections requiring intravenous antibiotics or hospitalization.\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of DAT-2645 and no history of bowel obstruction within 6 months prior to enrollment.\n* Known pulmonary interstitial disease or pulmonary interstitial fibrosis.\n* Patients known hypersensitivity to any component or excipient of DAT-2645.\n* Any unresolved toxicities from any prior therapy with severity great than CTCAE Grade 1 prior to start of DAT-2645, except for alopecia and pigmentation and Grade 2 of peripheral sensory neuropathy.\n* Participated in other clinical trials (except for screening failure) within 4 weeks prior to the first dose of the study drug in this study.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (active HBV infection is defined as positive hepatitis B surface antigen \\[HbsAg\\], or HBV DNA exceeding the lower limit of detection; active HCV infection is defined as positive anti-HCV antibody, and HCV RNA exceeding the lower limit of detection).\n* Known human immunodeficiency virus (HIV) infection (patients with adequate CD4+ T cell counts and without history of acquired immune deficiency syndrome \\[AIDS\\]-defining opportunistic infections could be enrolled after consultation with sponsor).\n* Women who are pregnant or breastfeeding.\n* History or evidence of any other clinically significant condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, would be a risk to patient safety or interfere with the study evaluation, procedures or completion.",{"count":716,"type":20},112,[23],"The primary objective of the study is to evaluate the safety, tolerability, PK, PD, and prilimary efficacy of a PARG inhibitor DAT-2645 in patients with advanced\u002Fmetastatic solid tumors harboring BRCA1\u002F2 loss of function alterations and\u002For other defects in the DNA damage repair (DDR) pathway.",[720,721,722,723,724,35,725,726,727,728,28],"Solid Cancers","BRCA Mutation","HRD Cancer","Breast Cancer","Prostate Cancer","Pancreatic Cancer","Endometrial Cancer","Gastric Cancer","Advanced Cancer",[730,731,732,733,734,735,736,737,738,739,740,741],"PARGi","DAT-2645","PARPi","Advanced solid tumors","Metastatic solid tumors","HRD gene alteration","Homologous recombination","BRCA","BRCA1\u002F2","PALB2","RAD51C","RAD51D","2024-09-26",{"date":744,"type":45},"2024-09-27",{"date":746,"type":20},"2024-11-01",{"date":748,"type":20},"2027-06-01",{"name":750,"class":52},"Danatlas Pharmaceuticals Co., Ltd"]