[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-malignant-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-malignant-solid-tumors":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,41,69,92,115,143,164,187,208,235,256,277,301,331,352,374,395,417],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100644148","phase-1-sctb41-plus-sctb39g-with-or-without-standard-therapy-in-advanced-solid-tumors-100644148",false,"NCT07665970","SCTB41 Plus SCTB39G With or Without Standard Therapy in Advanced Solid Tumors","An Open Multi-center Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB41 in Combination With SCTB39G With or Without Standard Therapy in Adult Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. Male or female, ≥ 18 years and ≤ 75 years old;\n3. Survival duration more than 3 months;\n4. ECOG score ≤ 1 point;\n5. Histologically or cytologically confirmed diagnosis of advanced malignant solid tumor；\n6. At least one measurable tumor lesion according to RECIST v1.1;\n7. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Has participated in another clinical study within 4 weeks prior to the first dose;\n2. Has previously received other immunotherapies other than PD-(L)1 inhibitors；\n3. Other malignancies diagnosed within 5 years prior to the enrollment;\n4. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n5. Significant bleeding risk;\n6. Presence of pleural effusion, peritoneal effusion, or ascites;\n7. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment；\n8. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n9. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n10. History of severe allergies, severe drug allergies (including unapproved investigational drugs);\n11. History of organ transplantation or stem cell transplantation;\n12. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n13. Pregnant or breastfeeding female.","ALL","18 Years","75 Years",{"count":20,"type":21},112,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 in combination with SCTB39G with or without standard therapy in adult patients with advanced malignant solid tumors. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[28],"Advanced Malignant Solid Tumors","NOT_YET_RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-26","ACTUAL",{"date":35,"type":21},"2026-06-30",{"date":37,"type":21},"2029-06-30",{"name":39,"class":40},"Sinocelltech Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100641219","phase-1-cib-in-vivo-car-t-lentiviral-injection-in-patients-with-advanced-malignant-tumors-100641219","NCT07657585","CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant Tumors","A Phase 1, Open-Label, Single-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CIB In Vivo CAR-T Lentiviral Injection in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 75 years.\n2. At least one measurable target lesion according to RECIST version 1.1 at screening.\n3. Histologically or cytologically confirmed advanced or metastatic malignant tumor, with positive target expression confirmed by validated assay methods.\n4. Patients who have failed prior standard systemic therapy (including but not limited to VEGF-targeted tyrosine kinase inhibitors and\u002For immune checkpoint inhibitors), or are intolerant to standard therapy.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Expected survival time ≥ 3 months as assessed by the investigator.\n7. Adequate organ function at baseline (no growth factor support or transfusion within 14 days prior to screening):\n\n   a. Bone marrow function: i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; ii. Hemoglobin (Hb) ≥ 90 g\u002FL; iii. Platelet count (PLT) ≥ 75 × 10⁹\u002FL. b. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); if liver metastases are present, ALT and AST ≤ 5 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN.\n\n   c. Renal function: Serum creatinine ≤ ULN or creatinine clearance rate ≥ 80 mL\u002Fmin.\n8. For female patients of childbearing potential, serum β-HCG test result must be negative within 7 days prior to enrollment.\n9. Patients must agree to use effective contraception from the signing of the informed consent form (ICF) until at least 90 days after the end of the study.\n10. Voluntarily sign the informed consent form (ICF) and be able to understand and comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Asymptomatic untreated brain metastases; symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; or other evidence of uncontrolled CNS\u002Fmeningeal metastases that are considered unsuitable for enrollment by the investigator.\n2. Presence of clinically significant cardiovascular, pulmonary, neurological, or systemic disease at baseline that may increase study participation risk or interfere with safety assessments.\n3. Presence of severe chronic or active infection at baseline, including:\n\n   1. Active hepatitis B (HBsAg positive with HBV DNA \\> ULN);\n   2. Active hepatitis C (anti-HCV positive with detectable HCV RNA);\n   3. Known history of or positive test for human immunodeficiency virus (HIV);\n   4. Systemic anti-infective therapy required within 4 weeks prior to first administration, including hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis.\n4. History of active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis) or receipt of long-term systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent) or other immunosuppressive agents within 4 weeks prior to first administration.\n5. Prior allogeneic tissue or solid organ transplantation.\n6. Evidence of severe immunodeficiency, such as primary immunodeficiency (e.g., severe combined immunodeficiency, SCID) or concurrent opportunistic infections.\n7. Prior gene therapy using lentiviral or retroviral vectors.\n8. Prior treatment with drugs targeting the same antigen.\n9. Requiring therapeutic anticoagulation that cannot be discontinued prior to administration.\n10. History of severe cardiovascular disease, including:\n\n    1. NYHA class ≥ II congestive heart failure;\n    2. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n    3. Corrected QT interval (QTcF) \\> 470 ms or long QT syndrome;\n    4. Acute coronary syndrome, aortic dissection, severe arrhythmia, stroke, or other grade ≥ 3 cardiovascular events within 6 months prior to first administration;\n    5. Uncontrolled hypertension.\n11. Prior anti-tumor therapy within 4 weeks or 5 half-lives (whichever is longer) prior to first administration, including chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy; prior oral small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is longer); prior palliative radiotherapy within 14 days; prior participation in other anti-tumor clinical trials within 4 weeks; prior use of any anti-tumor traditional Chinese medicine within 2 weeks.\n12. Pregnant or breastfeeding women, or women of childbearing potential who refuse to use effective contraception during the study period.\n13. Any other disease or laboratory abnormality that, in the investigator's opinion, makes the patient unsuitable for participation in this study.",{"count":49,"type":21},91,[24],"This is an open-label, single-arm, phase 1 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CIB in vivo CAR-T lentiviral injection in patients with advanced malignant tumors.\n\nThe study will enroll patients with histologically or cytologically confirmed advanced solid tumors that have progressed on or are intolerant to standard therapies. A \"3+3\" dose-escalation design will be used, with planned dose levels including 1×10⁵ TU\u002Fkg, 3×10⁵ TU\u002Fkg, 1×10⁶ TU\u002Fkg, 3×10⁶ TU\u002Fkg, 1×10⁷ TU\u002Fkg, and 3×10⁷ TU\u002Fkg. The primary objective is to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) based on dose-limiting toxicities (DLTs) observed within 28 days after administration. Secondary objectives include evaluating adverse events, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and pharmacokinetic parameters of the study drug.",[28],[54,55,56,57],"Advanced Solid Tumors","In Vivo CAR-T","Phase 1 Study","Dose Escalation","2026-06-14",{"date":60,"type":33},"2026-06-18",{"date":62,"type":21},"2026-07-01",{"date":64,"type":21},"2028-05-31",{"name":66,"class":67},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100643257","phase-1-n-3c01-monotherapy-and-combination-with-pd-l1-inhibitors-in-advanced-solid-tumors-100643257","NCT07639450","N-3C01 Monotherapy and Combination With PD-(L)1 Inhibitors in Advanced Solid Tumors","A Phase I\u002FII Clinical Study Evaluating the Safety, Tolerability, and Efficacy of N-3C01 as Monotherapy and in Combination With PD-(L)1 Monoclonal Antibody in Patients With Advanced Malignant Solid Tumors","Solid Tumors","Inclusion Criteria:\n\n1. Willingness to voluntarily participate in the study and provide written informed consent.\n2. Age 18 to 75 years (inclusive) at the time of signing the informed consent form, regardless of gender.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (refer to Appendix 1).\n4. Estimated life expectancy of ≥3 months.\n5. Disease criteria:\n\n   * Phase I: Patients with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors who have progressed following standard systemic therapy, have no available standard treatment options, are intolerant to standard therapies, or are deemed unsuitable for standard treatment by the Investigator.\n   * Phase II:\n   * Cohort 1: Advanced non-small cell lung cancer (NSCLC) with progression after immune checkpoint inhibitor therapy (as monotherapy or in combination with chemotherapy).\n   * Cohort 2: Advanced melanoma with progression following chemotherapy and\u002For immune checkpoint inhibitor therapy.\n   * Other cohorts: Tumor types such as colorectal cancer, renal cell carcinoma, head and neck squamous cell carcinoma, etc., that have progressed after chemotherapy and\u002For immune checkpoint inhibitor therapy and are considered potentially responsive by the Investigator.\n6. Presence of at least one measurable lesion per RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 (except for participants enrolled in the monotherapy dose-escalation phase).\n7. Adequate organ function.\n8. Use of effective contraception during the treatment period and for at least 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Presence of unstable central nervous system (CNS) metastases or concurrent primary intracranial tumors requiring treatment. Participants may be eligible if CNS disease is asymptomatic, radiologically stable for at least 4 weeks prior to the first dose, and does not require corticosteroids or anticonvulsant therapy.\n2. History of two or more primary malignancies, except for adequately treated and controlled malignancies such as cervical carcinoma in situ, breast carcinoma in situ, basal cell or squamous cell carcinoma of the skin, and papillary thyroid carcinoma, with no evidence of recurrence within the past 2 years.\n3. Uncontrolled tumor-related pain. Participants requiring analgesics must be on a stable pain management regimen at study entry.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites. Participants may be eligible if drainage is not required or if fluid accumulation remains stable for at least 3 days following drainage.\n5. Presence of significant pulmonary conditions, including idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or active pneumonitis at screening. Participants with prior radiation-induced pneumonitis (fibrotic changes confined to the radiation field) may be included.\n6. History of autoimmune disease, except for conditions that are well-controlled, including type 1 diabetes mellitus, hypothyroidism managed with hormone replacement, and dermatologic conditions not requiring systemic therapy (e.g., eczema, psoriasis, vitiligo, alopecia), as well as well-controlled celiac disease.\n7. Receipt of systemic corticosteroids within 1 week prior to the first dose or other systemic immunosuppressive therapies within 2 weeks (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide), except for physiologic replacement doses of prednisone ≤10 mg\u002Fday (or equivalent).\n8. History of clinically significant cardiovascular disease, including but not limited to:\n\n   Congestive heart failure (New York Heart Association \\[NYHA\\] class \\>2) Unstable angina Myocardial infarction within 3 months prior to the first study dose Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention\n9. History of clinically significant bleeding within 3 months prior to the first study dose. Participants with significant hemoptysis (i.e., coughing bright red blood of ≥2.5 mL per episode) within 1 month prior to the first dose are not eligible.\n10. History of arterial or venous thrombotic events within 6 months prior to the first study dose, including but not limited to cerebrovascular accident, deep vein thrombosis, or pulmonary embolism.\n11. Evidence of active tuberculosis (TB), as indicated by medical history or imaging (e.g., CT scan) within 1 year prior to enrollment, or a history of untreated active tuberculosis (TB) more than 1 year prior to screening.\n12. Severe infection within 4 weeks prior to the first study dose (e.g., bacteremia requiring hospitalization, severe pneumonia), or active infection requiring systemic antimicrobial therapy of CTCAE(Common Terminology Criteria for Adverse Events ) v6.0 Grade ≥2 within 2 weeks prior to dosing.\n13. Known history of immunodeficiency.\n14. Active viral or infectious diseases requiring treatment, including:\n15. Hepatitis B (HBsAg or HBeAg positive with Hepatitis C Virus (HBV) deoxyribonucleic acid (DNA) greater than or equal to 500 International Units per milliliter)\n16. Hepatitis C (positive Hepatitis C Virus (HCV) antibody with detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA))\n17. human immunodeficiency virus (HIV) infection\n18. Syphilis (positive serology with confirmatory Rapid Plasma Reagin (RPR)\u002FTRUST test)\n19. Toxicities from prior anti-cancer therapy that have not resolved to baseline or ≤Grade 1 (per Common Terminology Criteria for Adverse Events (CTCAE) v6.0), except for adverse events that are not clinically significant (e.g., alopecia), as determined by the Investigator.\n20. Receipt of any anti-tumor therapy-including surgery, chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy, traditional Chinese medicine, or investigational agents-within 4 weeks prior to the first study dose or within 5 half-lives of the respective drug (whichever is longer). Palliative radiotherapy for bone metastases within 2 weeks prior to the first dose is also not permitted.",{"count":78,"type":21},114,[24,25],"This Phase I\u002FII study evaluates the safety, tolerability, and efficacy of N-3C01 administered subcutaneously, both as monotherapy and in combination with a PD-(L)1 monoclonal antibody, in patients with advanced solid tumors. Phase I involves dose escalation for both monotherapy and combination therapy, while Phase II includes cohort expansion for the combination therapy.",[28],"2026-06-10",{"date":84,"type":33},"2026-06-12",{"date":86,"type":21},"2026-05-29",{"date":88,"type":21},"2028-09-30",{"name":90,"class":40},"Hefei Xinzhu Biological Technology Co., Ltd.",6,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100638181","phase-1-a-phase-i-study-of-jskn021-in-advanced-solid-tumors-100638181","NCT07617727","A Phase I Study of JSKN021 in Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form.\n2. Age ≥ 18 and ≤ 75 years old, male or female.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n4. Expected survival ≥ 3 months.\n5. Histologically or cytologically confirmed malignant solid tumors confirmed by histology and\u002For cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.\n6. At least one measurable lesion at baseline according to RECIST 1.1 criteria.\n7. Adequate organ function.\n8. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.\n9. Female subjects of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days before the first dose.\n10. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.\n11. Adequate washout period of previous therapy before the first dose.\n\nExclusion Criteria:\n\n1. Complicated with other malignant tumors within 3 years before the first dose.\n2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.\n3. Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.\n4. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.\n5. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:\n6. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n7. Uncontrolled infection.\n8. Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.\n9. Toxicity of previous anti-tumor treatment has not fully or partially recovered.\n10. Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.\n11. Pregnant and\u002For lactating women, or planning to become pregnant during the study period.\n12. Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.",{"count":100,"type":21},199,[24],"This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.",[28],[105,106],"EGFR\u002FHER3","JSKN021",{"date":108,"type":33},"2026-06-01",{"date":110,"type":21},"2026-05-31",{"date":112,"type":21},"2029-05-31",{"name":114,"class":40},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100640465","phase-1-a-study-of-cs231295-in-patients-with-advanced-solid-tumors-100640465","NCT07612488","A Study of CS231295 in Patients With Advanced Solid Tumors","A Phase 1, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CS231295 in Patients With Advanced Solid Malignant Tumors","Inclusion Criteria:\n\nPatients are eligible to be included in the study only if all of the following criteria apply:\n\n1. Subject provides voluntary informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol prior to performing any protocol-related procedures, including screening evaluations.\n2. Male or female ≥18 years at the time of Screening.\n3. Histologically or cytologically confirmed unresectable advanced, recurrent or metastatic solid tumors (including but not limited to small cell lung cancer (SCLC), brain gliomas, non-small cell lung cancer (NSCLC), pancreatic cancer, urothelial carcinoma, endometrial cancer, cervical cancer, ovarian cancer, breast cancer and liver cancer, etc.), who have failed or are intolerant to previous standard treatment (assessed by the investigator according to the diagnosis and treatment guidelines of the relevant disease) and currently have no standard treatment.\n\n   * Treatment failure must be documented by clear imaging or cell histopathology (such as cytology reports of new ascites or pleural effusion) to prove disease progression.\n   * Intolerance is defined as the termination of treatment due to adverse events that occur during treatment.\n   * Recurrence is based on imaging or cell histopathology results.\n4. At least one measurable target lesion (glioma, according to RANO 2.0; other solid tumors according to RECIST v1.1).\n\n   Note: The target lesion can be located in an area that has previously undergone radiotherapy. However, imaging examinations are required to confirm disease progression at the site after radiotherapy.\n5. Glioma: KPS score ≥ 60 points; other solid tumors: ECOG performance status score of 0 or 1 points.\n6. Life expectancy of ≥ 12 weeks.\n7. Major organ functions meet the following criteria:\n\n   (No blood components, hematopoietic growth factors, albumin, or other drugs deemed corrective treatment by the investigators should be used within 14 days prior to the screening, except for iron supplements.)\n   1. Hematology:\n\n      * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL,\n      * platelets ≥ 100 × 10\\^9\u002FL,\n      * hemoglobin ≥ 100 g\u002FL\n   2. Biochemistry:\n\n      * Total serum bilirubin ≤ 1.5 x ULN (\\\u003C 3.0 x ULN for patients with Gilbert's syndrome).\n      * In patients without hepatic metastasis: ALT and AST ≤1.5 × ULN.\n      * In patients with hepatic metastases, ALT and AST ≤3 × ULN.\n      * Measured or calculated creatinine clearance \\> 60 mL\u002Fmin (according to the Cockcroft-Gault equation, using actual body weight)\n   3. Coagulation Function: International Normalized Ratio (INR) \\\u003C 1.5 × ULN; Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for subjects receiving prophylactic anticoagulation therapy, the investigator should judge that both INR and APTT are within the safe and effective therapeutic range).\n   4. Urine protein \\\u003C 2+ by urinalysis. If patients have urine protein ≥2+ by urinalysis, a 24-hour urine protein quantification test should be performed. The patient cannot be enrolled if the quantified urine protein is ≥1 g\u002F24 h. The patient can still be enrolled if the quantified urine protein is \\\u003C1 g\u002F24 h.\n8. Women of childbearing potential (WOCBP) must be willing and able to take highly effective contraceptive measures during the entire study treatment period and for 12 weeks after the last dose of the study drug (see Appendix 13.3 for details). Women of childbearing potential include premenopausal and not sterilized (by hysterectomy, bilateral ligation of fallopian tubes, or bilateral oophorectomy) females who have passed menarche.\n9. Male patients must be willing and able to use male condoms and their female partners who are WOCBP during the entire study treatment and for the 12 weeks after the last dose of the study drug (see Appendix 13.3 for details).\n\nExclusion Criteria:\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. Received any form of intracranial radiotherapy within a specified time frame before the first dose of medication: 3 months for glioma and 2 weeks for other solid tumors.\n2. Any prior anti-tumor treatment such as radiotherapy (exclusion criterion #1 if intracranial radiotherapy), chemotherapy, immunotherapy, targeted therapy, cell therapy, endocrine anti-tumor therapy, tumor embolization, clinical trial drugs or devices that have not been approved for marketing, etc., within 28 days before the first medication.\n3. Patients have previously received treatment with Aurora kinase inhibitors.\n4. Has used a strong inducer or inhibitor of cytochrome P450 3A enzyme (CYP3A) within 14 days before the first dose of the study drug or is still within 7 half-lives of the drug (whichever is longer).\n5. Glioma: Use of \\> 5 mg\u002Fd dexamethasone or equivalent doses of other glucocorticoids for systemic treatment related to glioma within 1 week before the first dose.\n6. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or severe unhealed wounds, ulcers, or fractures performed within 4 weeks before the first dose of study medication.\n7. Any unresolved toxicity from previous anticancer therapy, defined as toxicities not yet resolved to NCI CTCAE Grade ≤1, except for alopecia or laboratory values deemed by the investigator to be of no clinical significance.\n8. History of another primary malignancy except for\n\n   1. Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of the study drug and of low potential risk for recurrence\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   3. Adequately treated carcinoma in situ without evidence of disease\n9. Advanced solid tumors other than glioma: Patients with active or untreated brain metastases, leptomeningeal metastases, spinal cord compression, or leptomeningeal carcinomatosis at the screening are excluded. Participants with previous brain metastases may participate only if they satisfy all of the following:\n\n   1. Has completed treatment (e.g., whole brain radiation treatment \\[WBRT\\], stereotactic radiosurgery, or equivalent)\n   2. Have stable disease for more than 4 weeks at the screening tumor assessment as confirmed by MRI or CT brain (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression).\n   3. Have been either off corticosteroids or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent) for at least 2 weeks before the first dose of study medications.\n   4. Have been off anticonvulsants for at least 2 weeks before the first dose of study medications.\n10. Combined with meningeal metastasis, except for glioma.\n11. Has severe brain herniation or a risk of brain herniation.\n12. Glioma: had a chip implant placed during glioma surgery.\n13. Pleural effusion, ascites, or pericardial effusion that have been drained within 1 month before the first dose of the study drug, or significant clinical symptoms (such as chest tightness, shortness of breath, dyspnea, etc.).\n14. Uncontrolled or significant cardiovascular diseases, including:\n\n    1. New York Heart Association (NYHA) grade II or higher congestive cardiac failure, unstable angina pectoris, and\u002For myocardial infarction within the 6 months prior to the first dose of the investigational drug, clinically significant arrhythmia unable to be controlled with medical treatment or left ventricular ejection fraction (LVEF) \\\u003C 50% at screening.\n    2. Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy).\n    3. Clinically significant history of prolonged QTc interval, or QTcF interval ≥470 ms, regardless of sex, during screening. If the report does not include a QTcF result, it must be calculated using the Fridericia correction formula (Fridericia QTc = QT\u002FRR\\^0.33).\n    4. Coronary heart disease with symptoms requiring medication.\n    5. Major cerebrovascular accidents (including cerebral hemorrhage, transient ischemic attack, etc.) within 6 months before the first medication.\n    6. Patient has hypertension at screening (defined as systolic blood pressure (SBP) ≥140 mmHg, diastolic blood pressure (DBP) ≥90 mmHg). \\[Patients with a known history of hypertension may be included if their blood pressure is well controlled on a single anti-hypertensive medication (SBP \\\u003C140 mmHg and DBP \\\u003C90 mmHg at screening). Additionally, these patients must not have experienced any changes in their blood pressure medication for at least three months prior to screening due to poor blood pressure control.\\]\n    7. Other cardiovascular diseases that the investigator judge to be unsuitable for inclusion in the study\n15. Poorly controlled diabetes (fasting blood glucose \\> 10 mmol\u002FL).\n16. Clinically significant gastrointestinal abnormalities that may affect the study drug's intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, or having undergone a total gastrectomy), as determined by the investigator.\n17. Clinically significant hemoptysis or tumor bleeding occurred within 14 days before the first medication, or history of active bleeding within 2 months prior to enrollment, or are currently taking anticoagulant drugs, such as warfarin, Phenprocoumon (prophylactic use of low-dose aspirin, low molecular weight heparin is permitted), or have a definite predisposition to bleeding as determined by the investigator (e.g., esophageal varix associated with bleeding risk, local active ulcer lesions, positive occult fecal blood that cannot rule out gastrointestinal bleeding, and imaging evidence indicating tumor invasion or infiltration of large blood vessels).\n18. History of severe thromboembolic events (such as arterial thrombotic events, pulmonary embolism, or deep vein thrombosis) occurred within 6 months prior to the initiation of the first medication. Thrombosis of implanted venous infusion ports or catheters, superficial venous thrombosis, or thromboembolism that is assessed by the investigator to be stable and does not require emergency medical intervention during the expected trial period is not considered \"serious\" thromboembolism.\n19. Ongoing or active infections that require intravenous systemic treatment during the screening period. Severe infection within 28 days before the first medication (including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications). Prophylactic antibiotic treatment (such as to prevent urinary tract infection or acute exacerbation of chronic obstructive pulmonary disease) can be included.\n20. Active tuberculosis infection (clinical evaluation that may include clinical history, physical examination, radiographic findings, or tuberculosis testing in accordance with local practice), currently receiving anti-tuberculosis treatment or having received anti-tuberculosis treatment within 1 year prior to the first use of the medication.\n21. Active hepatitis during the screening period: Hepatitis B surface antigen (HBsAg) positive with positive virus replication or hepatitis B core antibody (HBcAb) positive with positive virus replication. Hepatitis C antibody (HCV-Ab) positive with positive virus replication.\n22. HIV test positive or active syphilis infection (syphilis specific antibody and non-specific antibody positive) during screening.\n23. Known allergy or hypersensitivity to any of the study drugs or the study drug excipients.\n24. History of allogenic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n25. History of drug or alcohol abuse disorders that may affect study participation and clinical outcomes according to the investigator's judgment.\n26. Mental or cognitive disorders that could limit their understanding, execution, and compliance with the informed consent form and the study.\n27. Pregnant or lactating women. Female participants of childbearing potential or male participants with partners of childbearing potential who are unwilling or unable to use effective contraception from 7 days before the first dose of medication until 3 months after the end of treatment. Female participants of childbearing potential with a positive pregnancy test result within 7 days before the first dose of medication.\n28. The investigator determined that the patient was unsuitable for participation in the study and was unlikely to comply with the study's procedures, restrictions, and requirements.",{"count":123,"type":21},42,[24],"This is a Phase I, single-arm, open-label, dose-escalation, multicenter clinical study of CS231295 in patients with advanced solid malignant tumors.\n\nEligible patients must be 18 years or older and have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors, who have failed or are intolerant to previous standard treatments and currently have no other standard treatment options available. Patients should have at least one measurable target lesion (glioma, according to RANO 2.0; other solid tumors according to RECIST v1.1) and a Karnofsky Performance Status (KPS) score ≥ 60 (glioma) or an ECOG Performance Status score of 0 or 1 (other solid tumors).\n\nAfter screening, eligible patients will be enrolled sequentially in the dose-escalating cohorts.",[127,28],"Advance Solid Tumors",[129,130,131,132],"solid tumors","advanced malignant solid tumors","malignant tumors","advanced tumors","2026-05-27",{"date":135,"type":33},"2026-05-28",{"date":137,"type":21},"2026-06",{"date":139,"type":21},"2028-12",{"name":141,"class":40},"ThalassaX Therapeutics United States Ltd",4,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":68},"100629904","phase-2-phase-ii-study-of-js212js213-as-monotherapy-and-in-combination-in-patients-with-advanced-malignant-solid-tumors-100629904","NCT07480733","Phase II Study of JS212\u002FJS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors","A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age 18 to 75 years, male or female.\n2. Histologically confirmed metastatic or unresectable clear cell renal cell carcinoma (RCC); histologically or cytologically confirmed metastatic or unresectable castration-resistant prostate cancer (CRPC); histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (UC); histologically confirmed unresectable Stage III or IV melanoma.\n3. For RCC: disease progression following prior anti-angiogenic targeted therapy and PD-(L)1 inhibitor therapy; for CRPC: disease progression following prior abiraterone or novel androgen receptor (AR) inhibitor therapy; for UC: disease progression following prior PD-(L)1 inhibitor and platinum-based chemotherapy or PD-(L)1 inhibitor and ADC drugs; for melanoma: disease progression following prior chemotherapy and\u002For PD-(L)1 inhibitor therapy.\n4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. Life expectancy ≥ 12 weeks.\n7. Adequate organ function.\n8. Male and female subjects of reproductive potential must agree to use highly effective contraception during the study and avoid conception; women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and must not be breastfeeding.\n9. CRPC subjects must be on continuous luteinizing hormone-releasing hormone agonist (LHRHa) therapy or have undergone bilateral orchiectomy; subjects without bilateral orchiectomy must plan to maintain effective LHRHa therapy throughout the study; castrate levels of testosterone at screening; metastatic disease confirmed by CT\u002FMRI or radionuclide bone scan.\n10. Subjects voluntarily participate in the study and have signed the informed consent form.\n\nExclusion Criteria:\n\n1. Major surgery, radiotherapy, chemotherapy, immunotherapy or other anti-tumor therapy, or other investigational agents administered prior to the first study dose.\n2. Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 per CTCAE v6.0 or to the level specified in the inclusion\u002Fexclusion criteria.\n3. Presence of active central nervous system (CNS) metastases.\n4. Presence of clinically significant pleural effusion, ascites, or pericardial effusion requiring repeated intervention.\n5. Uncontrolled hypertension despite medical therapy, or history of hypertensive crisis or hypertensive encephalopathy.\n6. Severe cardiovascular or cerebrovascular disease.\n7. History of interstitial lung disease (ILD)\u002Fnon-infectious pneumonitis requiring corticosteroid therapy.\n8. Severe bone injury due to tumor bone metastasis as judged by the investigator.\n9. Severe infection (CTCAE v6.0 \\> Grade 2) within 28 days prior to the first study dose.\n10. Active tuberculosis, hepatitis B, or hepatitis C infection.\n11. History of immunodeficiency, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n12. History of another primary malignancy, except those with curative treatment and no known active disease for \\>5 years and low potential risk of recurrence.\n13. Known hypersensitivity or severe allergic reaction to the study treatment, any of its components, or excipients.\n14. Presence of any other condition that may result in premature discontinuation from the study.\n15. Diagnosis of any other malignancy within 5 years.\n16. Subjects participating in Cohorts 1, 3, 4, and 5:Prior treatment with an ADC targeting EGFR and\u002For HER3, or prior treatment with an ADC utilizing a topoisomerase I inhibitor as the payload；\n17. Subjects participating in Cohorts 2, 3, 4, and 5: Administration of any live or live-attenuated vaccine within 28 days prior to the first dose, or anticipated need for such vaccination during the study.Use of systemic corticosteroids or other immunosuppressive agents for ≥7 consecutive days within 14 days prior to the first dose.Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.Development of a drug-related adverse event leading to permanent discontinuation of prior anti-PD-(L)1 antibody therapy.\n18. Subjects participating in Cohorts 4:Imaging in the screening period demonstrates tumor encasement of major blood vessels, significant necrosis, or cavitation that, in the investigator's opinion, may confer a bleeding risk. Clinically significant hemoptysis or tumor bleeding of any cause within 28 days prior to the first dose.Gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months prior to enrollment, or current high risk of hollow organ perforation\u002Ffistula formation as judged by the investigator.History of gastrointestinal bleeding within 6 months prior to enrollment, or documented gastrointestinal bleeding tendency.Severe, non-healing or dehiscent wound, active ulcer, or untreated fracture.Significant bleeding diathesis or severe coagulopathy.Use of antiplatelet therapy or therapeutic anticoagulation within 14 days prior to the first dose.Development of a drug-related adverse event leading to permanent discontinuation of prior bevacizumab or similar agent therapy.",{"count":151,"type":21},410,[25],"This is a multicenter, open-label Phase II clinical study. The primary objective is to evaluate the investigator-assessed objective response rate of JS212 and JS213 as monotherapy and in combination regimens in patients with advanced solid tumors. This study aims to explore the safety, tolerability, and preliminary efficacy of JS212, JS213, as well as JS212 in combination with JS213, toripalimab, and JS207.",[28],"RECRUITING","2026-05-26",{"date":86,"type":33},{"date":159,"type":33},"2026-04-23",{"date":161,"type":21},"2028-11-11",{"name":163,"class":67},"Shanghai Junshi Bioscience Co., Ltd.",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":171,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100636481","phase-1-a-phase-i-clinical-study-of-ak150-in-advanced-malignant-solid-tumor-100636481","NCT07566247","A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK150 in Advanced Malignant Solid Tumor","Inclusion Criteria:\n\n1. Be able to understand and voluntarily sign the written informed consent form.\n2. Aged of ≥ 18 years and ≤75 years.\n3. ECOG PS 0 or 1.\n4. The expected lifespan is ≥3 months.\n5. Histologically or cytologically documented advanced or metastatic solid tumor that is refractory\u002Frelapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy.\n6. At least one measurable lesion according to RECIST v1.1.\n7. Adequate organ function.\n8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception\n\nExclusion Criteria:\n\n1. Having other active malignancies within 3 years.\n2. Currently participating in another interventional clinical study.\n3. Presence of active metastases to the central nervous system. For participants with asymptomatic brain metastasis or stable symptoms after treatment can be included.\n4. Having received any treatment targeting CSF-1R, ILT2 and ILT4..\n5. Having received systemic anti-tumor treatment within 28 days or major surgical operations are expected to be required during the study period.\n6. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.\n7. Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.\n8. Participants with active autoimmune diseases requiring systemic treatment within 2 years.\n9. Active infections, including those requiring intravenous antibiotics and antifungal treatment 2 weeks before the administration of the study, and unexplained fever during the screening period.\n10. Known to be positive for HIV and other infections.\n11. Live attenuated vaccines were received within 28 days.\n\n13\\. Participants with a history of mental illness and incapacitated or limited capacity.\n\n14\\. Women who are pregnant or lactating. 15.Known history of active tuberculosis. 16.Currently enrolled in any other clinical study. 17.Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.",true,{"count":173,"type":21},96,[24],"This study is an open-label, multicenter, dose-escalation and dose-expansion Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of AK150 in patients with advanced malignant solid tumors.",[28],"2026-04-29",{"date":179,"type":33},"2026-05-05",{"date":181,"type":21},"2026-04-30",{"date":183,"type":21},"2029-06-07",{"name":185,"class":40},"Akeso",3,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":68},"100554458","phase-1-a-study-of-fc084csa-in-combination-of-tislelizumab-in-patients-with-advanced-malignant-solid-tumors-100554458","NCT06499350","A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors","A Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of AXL Inhibitor FC084CSA Tablets in Combination With Tislelizumab in the Treatment of Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Aged 18 to 75 years old male and female.\n2. Phase Ib: Patients with histologically or cytologically diagnosed solid tumors who have failed standard therapy; Phase IIa: Patients with histologically or cytologically confirmed stage IIIB\u002FIIIC and stage IV NSCLC which surgery or radiotherapy cannot be performed.\n3. No known sensitizing mutations or other actionable oncogenes with approved therapies if available.\n4. Prior PD-1\u002FPD-L1 inhibitor combined with platinum-containing therapy failed;\n5. According to RECIST 1.1, there is at least one measurable lesion.\n6. ECOG performance status 0-1.\n7. Major organs are functioning well.\n\nExclusion Criteria:\n\n1. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).\n2. Received anti-tumor therapy within 4 weeks before enrollment.\n3. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.\n4. Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started.\n5. Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.\n6. Central nervous system metastases with clinical symptoms.\n7. With any situations that the researcher considers inappropriate to participate in this research.",{"count":195,"type":21},33,[24,25],"The goal of this clinical trial is to learn the safety, tolerability, pharmacokinetic characteristics and efficacy of FC084CSA in combination with Tislelizumab in patients with advanced malignant solid tumors.",[28],"2026-03-08",{"date":201,"type":33},"2026-03-10",{"date":203,"type":33},"2024-11-13",{"date":205,"type":21},"2026-10-01",{"name":207,"class":40},"FindCure Biosciences (ZhongShan) Co., Ltd.",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100571246","phase-1-a-study-of-cscjc3456-in-patients-with-advanced-malignant-tumors-100571246","NCT06717750","A Study of CSCJC3456 in Patients With Advanced Malignant Tumors","A Single-arm, Open-label, Single\u002FMultiple-dose Escalation, and Cohort Expansion Phase Ia\u002FIb Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Oral CSCJC3456 Tablets in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and follow protocol requirements;\n2. Aged 18 to 75 (both inclusive), male or female, regardless of race;\n3. Expected survival period ≥ 12 weeks;\n4. ECOG PS score ≤1;\n5. Phase Ia study:\n\n   ● Participants with advanced malignant solid tumors confirmed by pathology or cytology, who have experienced disease progression despite standard treatment, are intolerant to standard treatment, or lack effective standard treatment; and who possess at least one measurable lesion in accordance with RECIST v1.1 criteria;\n\n   Phase Ib study:\n   * Cohort A (hepatocellular carcinoma, including at least 2 participants with FGFR4 positivity), Cohort B (colorectal cancer, including at least 2 participants with FGFR1 or FGFR2 positivity), Cohort C (gastric cancer (including adenocarcinoma at the gastroesophageal junction), including at least 2 participants with FGFR1 or FGFR2 positivity), Cohort D (recurrent\u002Fmetastatic endometrial cancer, including at least 2 participants with FGFR2 or FGFR3 positivity), or other sensitive tumor types identified in phase Ia trial, confirmed by histology or cytology, who have failed or are intolerant to standard treatment. Investigators may adjust participant selection based on their response to treatment in the trial and communication with the sponsor.\n   * Each cohort of participants had at least one measurable lesion that met the criteria of RECIST v1.1.\n6. Before the first dose, the participant has recovered from the toxic effects of the previous last treatment (CTCAE grade ≤ 1, except for special conditions such as \"hair loss\" and \"pigmentation\"), and in addition, the investigator judges that the corresponding AE did not pose a safety risk;\n7. Systolic blood pressure ≤150 mmHg, diastolic blood pressure ≤90 mmHg, and no changes in antihypertensive medication and dosage within 7 days prior to the first administration.\n8. Adequate Organ and bone marrow function.\n9. Female participants of childbearing age must undergo a serum pregnancy test 7 days before starting the study medication, and the result must be negative. They must also be willing to adopt a medically approved highly effective contraceptive measure (e.g., an intrauterine device, contraceptive pills, or condoms) during the study period and for 3 months after the last administration of study medication. Male participants whose partners are female of childbearing age should agree to adopt an effective contraceptive method during the study period and for 3 months after the last administration of study medication. Breastfeeding women should agree to cease breastfeeding during the study period and for 3 months after the last administration of study medication.\n10. Have the gene sequencing results of the current tumor, or are willing to provide tumor tissue specimens (paraffin-embedded tissue blocks, or serial sections).\n\n    * Specimens are preferably derived from recently collected and usable tumor tissues. For relevant instructions, please refer to the Central Laboratory Manual.\n    * In cases where there is insufficient tumor tissue (e.g., insufficient number of available slides, including situations where no tissue specimens are available) and the investigator believes that another tumor tissue biopsy is unsafe, intolerable, infeasible, or the patient refuses, the patient can be enrolled in the study after discussion with the sponsor.\n\nExclusion Criteria:\n\n1. Previous or current diagnosis of other types of malignancy, except for the following:\n\n   1. Radically cured basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ, or breast cancer in situ;\n   2. Second primary cancer that has been cured with no recurrence within 5 years;\n2. Patients who are allergic to any component of the study drug or have a history of severe allergies;\n3. Having received any of the following treatments or medications before the first study treatment:\n\n   1. Major surgery or major trauma occurred within 4 weeks before the first study drug, but diagnostic tissue biopsies are allowed. Severe trauma refers to unhealed wounds, ulcers, or fractures;\n   2. Received treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications within 2 weeks before the first study drug treatment;\n   3. Received anti-neoplastic therapies (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biologic therapy, or tumor embolization) within 4 weeks or 5 half-lives of the investigational drug prior to the first dose, whichever is shorter;\n   4. Have received a potent CYP2C8 or CYP3A4 inducer within 2 weeks before the first dose; Or have received potent CYP2C8 or CYP3A4 inhibitors with less than 5 half-lives before the first dose;\n   5. Have received medications known to significantly prolong the QT interval (e.g., class Ia and class III antiarrhythmic drugs) within 1 week or 5 half-lives of the investigational drug prior to the first dose, whichever is shorter;\n   6. Previously received treatment with FGFR inhibitors (e.g., pemetrexed, erdafilone, infigranib, forodesine, ponatinib, dovitinib, nintedanib, AZD4547, NVP-BGJ398, LY2784455, BAY1163877, etc.);\n4. Patients with a history of central nervous system metastasis or spinal cord compression. Those who meet the following criteria can be enrolled:\n\n   1. Patients who have clearly received treatment and have been clinically stable for 4 weeks after discontinuing anticonvulsants and steroids prior to the first administration of the study drug (definition of clinical stability: no clinical accompanying symptoms such as intracranial hypertension or neurological symptoms within 4 weeks, and imaging findings indicating stable lesions within 4 weeks prior to the first administration of the drug);\n   2. For patients with brain metastases, ≥21 days from whole brain radiation therapy (WBRT) to the first study treatment administration, ≥7 days from stereotactic radiosurgery (SRS) to the first study treatment administration, or ≥28 days from surgical resection to the first study treatment administration;\n5. Advanced patients who have symptoms, spread to viscera, and are at risk of life-threatening complications in a short period of time, patients who have undergone at least two paracentesis and drainage within 4 weeks before the first dose, or patients who have undergone one paracentesis and drainage but have unstable pleural effusion, peritoneal effusion, or pericardial effusion;\n6. Within the 6 months prior to screening, having a cardiovascular disease.\n7. Uncontrolled systemic diseases, such as diabetes, hypertension, etc.;\n8. Currently suffering from sudden pulmonary disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary disease, etc., except for local interstitial pneumonia induced by radiotherapy;\n9. Patients with a clear tendency towards gastrointestinal bleeding, including the following conditions: those with a history of black stool or hematemesis within 2 months; those whom investigators believe may have a high risk of major gastrointestinal bleeding;\n10. Patients with previous or current grade ≥3 gastrointestinal perforation or visceral fistula;\n11. Grade ≥3 diarrhea during the screening period;\n12. Evidence of active infection.\n13. Positive for human immunodeficiency virus (HIV RNA) or treponema pallidum antibodies;\n14. Have multiple factors that affect oral medication (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.) or a condition that the investigator has judged to severely affect gastrointestinal absorption;\n15. Having a clear history of neurological or psychiatric disorders, including epilepsy or dementia;\n16. Having received any investigational drug within 4 weeks before the first administration, or participating in another clinical study at the same time (excluding the following situations: the patient is participating in an observational, non-interventional clinical study, or is in the follow-up period of an interventional clinical study; or the last study drug has been taken for more than 5 half-lives);\n17. Patients deemed unsuitable for inclusion in this study by the investigators.",{"count":216,"type":21},102,[24],"This study is a multicenter, open phase I clinical study of dose escalation, cohort expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CSCJC3456 in patients with advanced malignant solid tumors.",[28],[221,222,223,224],"Neoplasms","Antineoplastic Agents","Tyrosine Kinase Inhibitors","Protein Kinase Inhibitors","2026-01-30",{"date":227,"type":33},"2026-02-02",{"date":229,"type":33},"2025-02-13",{"date":231,"type":21},"2028-06-30",{"name":233,"class":40},"Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.",2,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":4},"100620880","phase-1-exploratory-clinical-study-of-fap-mrna-vaccine-in-patients-with-advanced-malignant-solid-tumors-100620880","NCT07363369","Exploratory Clinical Study of FAP mRNA Vaccine in Patients With Advanced Malignant Solid Tumors","An Exploratory Basket Study on The Application of Therapeutic mRNA Vaccine Targeting FAP in Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* 1\\. Male or female patients: aged ≥ 18 years old;\n* 2\\. Patients with histopathologically confirmed advanced malignant solid tumors (such as patients with advanced lung cancer, advanced colorectal cancer, advanced pancreatic carcinoma, etc.);\n* 3\\. Patients refractory or intolerant to standard clinical treatment regimens;\n* 4\\. According to the RECIST 1.1 criteria, at least one measurable lesion is required;\n* 5\\. Eastern Cooperative Oncology Group (ECOG) performance status score: 0 - 1;\n* 6\\. Expected survival time ≥ 3 months;\n* 7\\. Main organ functions are in good condition;\n* 8\\. Participants must have no plans for pregnancy during the treatment period and agree to use effective contraception voluntarily throughout the study period and for four months after discontinuation of treatment;\n* 9\\. Sign a written informed consent form;\n* 10\\. Ability to communicate effectively with the research team and willingness to comply fully with all protocol-specified requirements.\n\nExclusion Criteria:\n\n* 1\\. History of other malignancies, except for adequately treated and non-recurrent within 5 years prior to screening basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or gastrointestinal mucosal carcinoma, which the investigator deems eligible for inclusion;\n* 2\\. Known central nervous system (CNS) metastases that are untreated or not effectively controlled by prior therapy;\n* 3\\. Patients with serious cavity effusion;\n* 4\\. Patient has comorbid conditions associated with elevated FAP expression beyond solid tumors, including pulmonary fibrosis, liver fibrosis, renal fibrosis, and rheumatoid arthritis, etc.;\n* 5\\. Patients with uncontrolled cardiac clinical symptoms or diseases, such as heart failure of NYHA class II or above, unstable angina pectoris, having had a myocardial infarction within six months, and having clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;\n* 6\\. A history of thrombotic events (arterial or venous) within 6 months prior to enrollment, such as deep vein thrombosis, and pulmonary embolism;\n* 7\\. Any active autoimmune disease or history of autoimmune diseases, including but not limited to: neurologic diseases related to immunity, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disorders, scleroderma, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (excluding type 1 diabetes mellitus controlled with stable-dose insulin);\n* 8\\. According to the investigator's judgment, there are concomitant uncontrolled diseases that may seriously endanger patient safety or affect the patient's completion of the study;\n* 9\\. A known history of interstitial pneumonia or highly suspected interstitial pneumonia; or patients with lung abnormalities that could interfere with the detection or management of suspected drug-related pulmonary toxicity during the study;\n* 10\\. Known allergy to the investigational drug (including any excipients). A history of severe allergic reactions to any drugs, foods, or vaccines, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, localized allergic necrotic reactions (Arthus reaction), etc.;\n* 11\\. The last anti-cancer treatment occurred less than 4 weeks before the first vaccination; patients with unresolved treatment-related adverse effects (except hair loss) from previous anti-cancer treatments;\n* 12\\. Patients who have previously received treatment with immune checkpoint inhibitors and experienced immune-related adverse events graded ≥3 according to the NCI CTCAE criteria;\n* 13\\. Systemic treatment with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent doses of other glucocorticoids) or other immunosuppressive agents within 14 days before the first dose of the vaccine. However, the following situations are allowed: In the absence of active autoimmune disease, inhaled or local use of corticosteroids or adrenal hormone replacement with \\\u003C=10 mg\u002Fday prednisone is allowed;\n* 14\\. Received mRNA vaccines or lipid nanoparticles (LNP) or equivalent nanoparticle delivery drugs within 6 months prior to the first dose of the vaccine;\n* 15\\. Previously received live attenuated vaccine\u002Finactivated vaccine within 6 months;\n* 16\\. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* 17\\. Blood donation or significant blood loss (\\>450 mL) within 3 months prior to screening;\n* 18\\. Major surgery within 4 weeks prior to screening (small surgeries such as catheter placement, biopsy required by the protocol, etc., are not exclusion criteria), or the surgical or traumatic effects have not been resolved within 14 days before enrollment;\n* 19\\. A history of drug abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug abuse;\n* 20\\. Human immunodeficiency virus (HIV) positive, or positive for syphilis antibodies; patients with active HBV infection, or HCV infection;\n* 21\\. Patients with active tuberculosis (TB) or a history of active TB; or those requiring systemic treatment for severe acute or chronic infections\n* 22\\. Pregnant or breastfeeding women;\n* 23\\. Any other factors that the investigator believes may make the patient unsuitable for participation in the study.",{"count":243,"type":21},10,[24],"Cancer-associated fibroblasts (CAFs), as core regulators within the tumor microenvironment, significantly impede the intratumoral penetration of therapeutic agents and suppress the effective infiltration and activation of immune cells by constructing elaborate physical and functional barriers. Fibroblast activation protein (FAP) is a highly specific therapeutic target for CAFs, owing to its nearly tumor-restricted expression profile. Therefore, developing therapeutic strategies that specifically target FAP to eliminate CAFs and subsequently remodel the tumor microenvironment may effectively disrupt the multi-dimensional defense system established by CAFs, thereby significantly enhancing the delivery efficiency of anti-tumor agents and improving responsiveness to immunotherapy.\n\nThis Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of FAP mRNA Vaccine combined with immune checkpoint inhibitors in patients with advanced malignant solid tumors.",[28],"2026-01-22",{"date":249,"type":33},"2026-01-23",{"date":251,"type":21},"2026-01-25",{"date":253,"type":21},"2027-12-31",{"name":255,"class":67},"West China Hospital",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":267,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":68},"100621246","phase-1-a-study-of-tpd3310-in-patients-with-advanced-malignant-tumors-100621246","NCT07368127","A Study of TPD3310 in Patients With Advanced Malignant Tumors","A Single-Arm, Open-Label, Dose-Escalation\u002FCohort-Expansion Phase Ia\u002FIb Study to Evaluate Safety, Tolerability, PK\u002FPD Profiles, and Preliminary Efficacy of TPD3310 Injection in Advanced Malignant Solid Tumor Patients","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and follow protocol requirements.\n2. Aged 18 to 75 (both inclusive), male or female, regardless of race.\n3. Expected survival period ≥ 12 weeks.\n4. ECOG PS score ≤1.\n5. Phase Ia study:\n\n   •Patients with pathologically or cytologically confirmed advanced malignant solid tumors (not limited to lung cancer, gastric cancer, liver cancer and cholangiocarcinoma, esophageal cancer, pancreatic cancer, and renal cancer) who have progressive disease despite standard treatment, are intolerant to standard treatment, or lack effective standard treatment; c-MET positive patients are preferred. At least one measurable lesion meeting RECIST v1.1 criteria;\n\n   Phase Ib study:\n   * Cohort A (histologically or cytologically confirmed lung cancer, failed or intolerant to standard treatment, EGFR wild-type, c-MET positive. Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.), Cohort B (histologically or cytologically confirmed esophageal cancer, failed or intolerant to standard treatment, c-MET positive. Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.), Cohort C (histologically or cytologically confirmed gastric cancer (including gastroesophageal junction adenocarcinoma), failed or intolerant to standard treatment, c-MET positive. Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.), Cohort D (histologically or cytologically confirmed liver cancer and cholangiocarcinoma, failed or intolerant to standard treatment, c-MET positive. Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.), Cohort E(histologically or cytologically confirmed pancreatic cancer, failed or intolerant to standard treatment, c-MET positive.Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.), Cohort F(histologically or cytologically confirmed renal cancer, failed or intolerant to standard treatment, c-MET positive. Investigators may adjust enrollment criteria after communicating with the sponsor based on subjects' efficacy responses during the trial.) or other sensitive tumor types identified in phase Ia trial.\n   * Each cohort of participants had at least one measurable lesion that met the criteria of RECIST v1.1.\n6. Recovered from toxic effects of previous last treatment before the first dose (CTCAE ≤ Grade 1, except for special cases such as alopecia and hyperpigmentation); in addition, investigators judge that the corresponding AE has no safety risks.\n7. Systolic blood pressure ≤ 160 mmHg, diastolic blood pressure ≤ 100 mmHg, and no changes in antihypertensive drugs and dosages within 7 days before the first dose.\n8. Organ and bone marrow function must meet the following requirements:\n\n   * Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL, platelet count ≥ 75×10⁹\u002FL, hemoglobin ≥ 90 g\u002FL; no blood transfusion or biologic response modifier (e.g., granulocyte colony-stimulating factor, erythropoietin, interleukin-11, etc.) treatment within 14 days before the first dose.\n   * Liver function: No history of cirrhosis (i.e., no decompensated cirrhosis Child-Pugh Class B or C). For subjects without liver metastasis: serum total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN) (≤ 2.0×ULN for Gilbert syndrome), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN. For subjects with liver metastasis or liver cancer: TBIL ≤ 2.5×ULN, ALT and AST ≤ 5×ULN.\n   * Renal function: Creatinine clearance rate ≥ 50 mL\u002Fmin (Cockcroft-Gault formula) or serum creatinine \\\u003C 1.5×ULN; urine protein qualitative ≤ 1+. If urine protein qualitative ≥ 2+, 24-hour urine protein quantitative test is required; investigators make enrollment judgment based on test results.\n   * Coagulation function: Prothrombin time (PT) ≤ 1.5×ULN; international normalized ratio (INR) ≤ 1.5×ULN, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN. (INR \\\u003C 2.5×ULN for subjects receiving anticoagulant therapy)\n9. Female subjects of childbearing age must undergo serum pregnancy test within 7 days before the start of study drug administration, with negative results; and agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) during the study and within 3 months after the last dose of study drug. Male subjects whose partners are of childbearing age must agree to use effective contraception during the study and within 3 months after the last dose of study drug. Lactating females must agree to discontinue breastfeeding during the study and within 3 months after the last dose of study drug.\n10. Phase Ib trial: Meet any of the following conditions:\n\n    * Previously confirmed c-MET positive; lung cancer cohort requires EGFR wild-type.\n    * After collecting subjects' tumor tissue samples, confirmed c-MET positive by central laboratory testing. Requirements for subjects to provide tumor samples: paraffin blocks within 2 years; paraffin-embedded sections within 6 months (at least 5 slices), or fresh tissue, etc.; tumor cell proportion in samples ≥ 20%. (If tumor samples exceed the above time requirements, communication with the sponsor is allowed to determine acceptability)\n    * Definition of c-MET positive: IHC ≥ 2+; or FISH amplification (GCN ≥ 5).\n\nExclusion Criteria:\n\n1. Previous or current history of other types of malignant tumors, except for the following situations:\n\n   * Curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.\n   * Second primary cancer that has been cured with no recurrence within 5 years.\n2. Subjects allergic to any component of the study drug or with a history of severe allergies.\n3. Received any of the following treatments or drugs before the first study treatment:\n\n   * Major surgery or severe trauma within 4 weeks before the first study drug administration (major surgery is defined as any invasive surgery involving extensive resection or opening of mesothelial barriers such as pleural cavity, peritoneal cavity, or meninges; however, tissue biopsy for diagnostic purposes is allowed. Severe trauma refers to unhealed wounds, ulcers, or fractures).\n   * Traditional Chinese medicine (including proprietary Chinese medicine) with antitumor indications within 2 weeks before the first study drug administration.\n   * Antitumor treatment (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biotherapy, or tumor embolization) within 2 weeks before the first dose or within 2 half-lives of the therapeutic drug (whichever is shorter).\n   * Strong CYP3A4 inducers or inhibitors within 2 weeks before the first dose and for less than 5 half-lives.\n   * Drugs known to significantly prolong the QT interval (e.g., Class Ia and III antiarrhythmic drugs) within 1 week before the first dose.\n4. Subjects with meningeal metastasis.\n5. Subjects with a history of other central nervous system (CNS) metastases or spinal cord compression; enrollment is allowed if the following conditions are met:\n\n   * Clearly received treatment and clinically stable after discontinuing anticonvulsants and steroids for 4 weeks before the first study drug administration (clinical stability is defined as no clinical accompanying symptoms such as increased intracranial pressure or neurological symptoms within 4 weeks and imaging suggesting stable lesions within 4 weeks before the first dose).\n   * For subjects with brain metastasis: Interval from whole-brain radiotherapy (WBRT) to the first study treatment administration ≥ 21 days; interval from stereotactic radiosurgery (SRS) to the first study treatment administration ≥ 7 days; or interval from surgical resection to the first study treatment administration ≥ 28 days.\n6. Advanced subjects with symptomatic visceral dissemination at risk of life-threatening complications in the short term; subjects who underwent at least two puncture drainages within 4 weeks before the first dose; or subjects who underwent one puncture drainage but with unstable pleural effusion, peritoneal effusion, or pericardial effusion.\n7. Cardiovascular diseases meeting any of the following within 6 months before screening:\n\n   * Congestive heart failure with New York Heart Association (NYHA) Class ≥ III.\n   * Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n   * Severe arrhythmia requiring drug treatment.\n   * QTcF (Fridericia formula) \\> 450 milliseconds, or risk factors for torsades de pointes (TdP), such as clinically significant hypokalemia (e.g., CTCAE severity ≥ Grade 3 or requiring intravenous treatment) judged by investigators, family history of long QT syndrome, or family history of arrhythmia (e.g., Wolff-Parkinson-White syndrome)\n   * Myocardial infarction, severe\u002Funstable angina pectoris within 6 months before administration.\n   * History of Grade ≥ 3 thromboembolic events within the past 2 years, or receiving thrombolysis due to high thrombosis risk.\n8. Presence of other serious diseases, including liver disease, kidney disease, neuropsychiatric disease, endocrine disease, hematological disease, and immune system disease, which investigators judge will affect participation in the study.\n9. Enlargement of the thyroid or parathyroid gland.\n10. Current acute lung disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary disease, etc., excluding local interstitial pneumonia induced by radiotherapy.\n11. Subjects with clear gastrointestinal bleeding tendency, including the following situations: History of melena or hematemesis within 2 months; investigators judge that massive gastrointestinal bleeding may occur.\n12. Previous or current history of Grade ≥ 3 gastrointestinal perforation or visceral fistula.\n13. Adverse events from previous treatment failed to recover to ≤ Grade 1, except for alopecia, clinically insignificant abnormal laboratory findings related to the disease, hypothyroidism stabilized by hormone replacement therapy, and other toxicities with no safety risks judged by investigators.\n14. Evidence of active infection:\n\n    * Hepatitis B (simultaneous positivity for HBsAg and HBV-DNA ≥ 2000 IU\u002Fml).\n    * Hepatitis C (simultaneous positivity for HCV antibody (HCV-Ab) and HCV-RNA above the lower limit of detection of the analytical method).\n    * Systemic anti-infective treatment for ≥ 7 days within 4 weeks before the first dose, or unexplained fever \\> 38.5℃ during screening\u002Fbefore the first dose (fever caused by tumors is allowed as judged by investigators).\n    * Active pulmonary tuberculosis infection detected by medical history or CT examination, or history of active pulmonary tuberculosis infection within 1 year before enrollment, or history of active pulmonary tuberculosis infection more than 1 year ago without regular treatment.\n15. Positive for human immunodeficiency virus (HIV RNA) or Treponema pallidum antibody.\n16. Previous clear history of neurological or psychiatric disorders, including epilepsy or dementia.\n17. Received any investigational drug within 4 weeks before the first dose, or concurrently participating in another clinical study (exceptions: subjects participating in observational, non-interventional clinical studies, or in the follow-up period of interventional clinical studies; or the last study drug administration was more than 5 half-lives ago).\n18. Subjects judged by investigators as unsuitable for inclusion in the study.",{"count":20,"type":21},[24],"This study is a multicenter, open phase I clinical study of dose escalation,cohort expansion study to evaluate the safety,tolerability,pharmacokinetics,pharmacodynamics, and preliminary efficacy of TPD3310 in patients withadvanced malignant solid tumors.",[28],[221,222],"2026-01-20",{"date":270,"type":33},"2026-01-26",{"date":272,"type":21},"2026-03-01",{"date":274,"type":21},"2029-03-01",{"name":276,"class":40},"TAIBIDI PHARMACEUTICAL TECHNOLOGY(SHIJIAZHUANG) CO.,LTD.",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":289,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":300,"locationsCount":68},"100615422","phase-1-jskn022-in-subjects-with-advanced-malignant-solid-tumors-100615422","NCT07292402","JSKN022 in Subjects With Advanced Malignant Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics, and Antitumor Activity of JSKN022 in Subjects With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form.\n2. Age ≥ 18 years old, male or female.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n4. Expected survival ≥ 3 months.\n5. Histologically or cytologically confirmed malignant solid tumors confirmed by histology and\u002For cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.\n6. At least one measurable lesion at baseline according to RECIST 1.1 criteria.\n7. Adequate organ function.\n8. Agree to provide Recently archived or fresh tumor tissue samples.\n9. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.\n10. Female subjects of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days before the first dose.\n11. Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.\n12. Adequate washout period of previous therapy before the first dose.\n\nExclusion Criteria:\n\n1. Complicated with other malignant tumors within 5 years before the first dose, except for tumor types that have achieved clinical cure through local treatment with extremely low recurrence risk or tumor types with disease-free survival ≥ 5 years after radical treatment and extremely low recurrence\u002Fmetastasis risk.\n2. History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.\n3. Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula, except those judged by the investigator and medical monitor to not affect the patient's enrollment and administration.\n4. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.\n5. Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:\n6. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n7. Gastrointestinal abnormalities with obvious clinical manifestations.\n8. Active autoimmune diseases requiring systemic treatment within the past two years.\n9. Significant serous effusion.\n10. Uncontrolled infection.\n11. Require regular glucocorticoid or immunosuppressive therapy.\n12. Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.\n13. Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors.\n14. Previous occurrence of grade ≥ 3 immune-related adverse events during immunotherapy.\n15. Toxicity of previous anti-tumor treatment has not fully or partially recovered.\n16. Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.\n17. Pregnant and\u002For lactating women, or planning to become pregnant during the study period.\n18. Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.\n19. Local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to high medical risks and\u002For uncertainty in survival assessment, such as tumor-related leukemia reaction (white blood cell count \\> 20×10⁹\u002FL), cachexia manifestations, etc.\n20. Any other previous or current diseases, treatments, or laboratory test abnormalities that the investigator deems may confuse the study results, affect the patient's full participation in the study, or participation in the study may not be in the best interest of the patient.",{"count":285,"type":21},225,[24],"The goal of this clinical trial is to learn if drug JSKN022 is safe to treat patients with advanced malignant solid tumors. It will also learn about the pharmacokinetic\u002F pharmacodynamic profiles and preliminary antitumor activity of drug JSKN022.",[28],[290,291,292,293],"JSKN022","PD-L1","ITGB6","Antibody-Drug Conjugates","2025-12-17",{"date":296,"type":33},"2025-12-23",{"date":298,"type":33},"2025-10-23",{"date":253,"type":21},{"name":114,"class":40},{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":313,"conditions":314,"keywords":315,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":68},"100496852","using-neoantigen-peptide-vaccineneoantigen-based-dc-to-treat-advanced-malignant-solid-tumors-100496852","NCT05749627","Using Neoantigen Peptide Vaccine\u002Fneoantigen-based DC to Treat Advanced Malignant Solid Tumors","A Clinical Study of Personalized Tumor Neoantigen Peptide Vaccine\u002Fneoantigen-based Dendritic Cells in the Treatment of Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* With inoperable advanced malignant solid tumors, including melanoma, gastrointestinal tumor, breast cancer, pancreatic cancer, cervical cancer, lung cancer, etc.\n* Failed in standard treatment or voluntarily give up other treatment, and been longer than 2 weeks from the end of the last anti-tumor treatment\n* Had disease progression prior to treatment\n* Expected survival ≥ 3 months\n* ECOG performance status of 0, 1, or 2\n* With a negative pregnancy test for females of childbearing age\n* Able to take effective contraceptive measures and ensure that there is no birth plan within half a year of the study\n* Not positive for HIV, HBV, HCV, or TP\n* ALT\u002FAST ≤ 2.5 times the upper limit of normal\n* ALP ≤ 2.5 times the upper limit of normal\n* Serum creatinine ≤1.6 mg\u002FdL\n* Total bilirubin ≤ 1.5 mg\u002FdL\n* In the absence of granulocyte colony-stimulating factor support, proportion of lymphocytes \\> 20%, absolute neutrophil count ≥ 1x10\\^9\u002FL, white blood cell count ≥ 3x10\\^9\u002FL, platelet count ≥ 100×10\\^9\u002FL, hemoglobin \\> 8.0 g\u002FdL, CD4+ cell count \\> 200\u002FμL\n* With normal coagulation test and ECG\n* Able to understand and willing to sign a written informed consent form\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with brain metastases\n* Had immunosuppressant therapy within 1 month or received other immunotherapy within 3 months\n* Participated in other clinical study within 30 days\n* With severe allergies or histories of severe allergy\n* With splenectomy\n* With primary or secondary immunodeficiency diseases or autoimmune diseases (including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, psoriasis, uncontrolled asthma, etc.)\n* Had oral, intramuscular, or intravenous corticosteroids within 1 month. However, inhaled corticosteroids are allowed to treat respiratory insufficiency (such as chronic obstructive pulmonary disease), as well as topical steroids\n* With uncontrollable epilepsy, central nervous system disorder, or neurological disease with loss of cognitive ability\n* With a history of chronic alcohol or drug abuse within 6 months\n* With unstable systemic diseases (including active infection, liver cirrhosis, chronic renal failure, severe chronic pulmonary disease, unstable hypertension, unstable angina, congestive heart failure, myocardial infarction within 1 year, etc.)\n* With a history of other malignant tumors in the past 5 years (excluding those who have been clinically cured, and squamous cell carcinoma or skin basal cell carcinoma)\n* Those the researcher believed inappropriate to participate in this study","70 Years",{"count":310,"type":21},20,[312],"NA","In this study, the investigators provide a personalized tumor neoantigen peptide vaccine\u002Fneoantigen-based DC treatment to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the neoantigen-based DC treatment.",[28],[316,317,318,28,319,320,321],"Neoantigen Peptide Vaccine","Neoantigen-based Dendritic Cells","Therapeutic immune preparation","Progression-free Survival","Overall Survival","Overall Response Rate","2025-02-25",{"date":324,"type":33},"2025-02-27",{"date":326,"type":33},"2023-04-01",{"date":328,"type":21},"2025-12-31",{"name":330,"class":67},"The First Affiliated Hospital of Nanchang University",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":68},"100559998","phase-1-phase-i-study-of-wj47156-monotherarpy-and-in-combination-with-other-therapy-in-advanced-solid-tumors-100559998","NCT06571422","Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors","A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WJ47156 Monotherapy and in Combination With Other Anti-Tumor Therapies in Patients With Advanced Malignant Solid Tumors","Inclusion criteria:\n\n1. Male or female, 18 to 75 years old (inclusive) at the time of signing the ICF;\n2. Patients with histologically or cytologically confirmed advanced malignant solid tumors；\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n4. Life expectancy ≥ 12 weeks;\n5. At least one measurable lesion according to RECIST 1.1;\n6. Adequate organ function ；\n7. Female or male patients of childbearing potential must agree that they have no intention to become pregnant during the study and for 6 months after the last dose, and to use highly effective contraceptive methods with their partners; );\n8. Voluntary participation with full informed consent by signing an written informed consent, and with good compliance.\n\nExclusion Criteria\n\n1. CNS metastasis；\n2. Pleural effusion, peritoneal effusion or pericardial effusion with clinical symptoms or requiring repeated treatment (e.g., puncture or drainage);\n3. Unable to swallow tablets, intestinal obstruction, or other factors affecting the administration and gastrointestinal absorption of tablets\n4. For the combination therapy, patients will not be enrolled in this study if they meet any of the following criteria:\n\n（1）Imaging findings at screening showing tumor encasement of a major vessel or significant necrosis and cavity, which may lead to a hemorrhagic risk as judged by the investigator; （2）Patients with active autoimmune diseases requiring systemic treatment (e.g., corticosteroids or immunosuppressive drugs) within 2 years prior to the first dose, including but not limited to systemic systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, vasculitis, etc. However, hypothyroidism, hypoadrenalism or hypopituitarism controlled only by hormone replacement therapy, Type I diabetes mellitus not requiring systemic treatment, psoriasis or vitiligo are allowed; （3）Previously treated with anti-PD-1\u002FL1 therapy; （4）History of interstitial lung disease or previous history of non-infectious pneumonia treated with corticosteroids, or evidence of active pneumonia on imaging at screening; （5）Gastrointestinal perforation, fistula, abdominal abscess and ulcerative disease or history of digestive system ulcerative disease within 6 months prior to the first dose (patients with stable ulcer as assessed by the investigator may be considered for enrollment); （6）Presence of serious, unhealed, or open wounds, active ulcers, or untreated fractures; （7）History of gastrointestinal bleeding within 6 months prior to enrollment, or clear tendency of gastrointestinal bleeding (including hemorrhagic risk of severe esophageal-gastric varices, locally active digestive tract ulcerative lesion, and persistent positive fecal occult blood); （8）Clinically significant hemoptysis or tumor bleeding for any reason within one month prior to the first dose; （9）History of obvious bleeding tendency or severe coagulation dysfunction; （10）Severe drug-related adverse events leading to permanent discontinuation of the drug product or bevacizumab or its analogues; （11）Use of antiplatelet therapy or anticoagulant therapy for treatment within 14 days prior to the first dose; （12）Long-term treatment with nonsteroidal anti-inflammatory drugs is permitted for brief periods of time to relieve symptoms such as fever or pain.\n\n5\\. Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg) or history of hypertensive crisis or hypertensive encephalopathy; 6. Severe cardiovascular disease, including but not limited to, myocardial infarction, severe\u002Funstable angina, congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ 2), clinically significant supraventricular or ventricular arrhythmia requiring drug intervention, aortic aneurysm requiring surgical repair, any arterial thrombosis\u002Fembolism event, Grade 3 or higher (Common Terminology Criteria for Adverse Events \\[CTCAE\\] v5.0) venous thrombosis\u002Fembolism event, transient ischemic attack, cerebral vascular accident; Left ventricular ejection fraction (LVEF) \\\u003C 50% by echocardiography. Corrected QT interval (QTc) \\> 480 ms (calculated using the Fridericia method; if QTc is abnormal, measure 3 times at an interval of 2 minutes and use the average).\n\n7\\. Serious infection (CTCAE Grade \\> 2) within 28 days prior to the first dose, such as serious pneumonia, bacteremia, infection and complications requiring hospitalization; or active infection or unknown cause of fever (\\>38.5℃) requiring systemic anti-infection treatment within 2 weeks prior to the first dose (as judged by the investigator, patients with tumor-induced fever can be enrolled);\n\n8\\. Presence of active tuberculosis, hepatitis B (positive for hepatitis B surface antigen \\[HBsAg\\] and HBV DNA higher than the lower limit of detection in the study site), hepatitis C (positive for HCV antibody \\[HCVAb\\] and HCV RNA higher than the lower limit of detection in the study site);\n\n9\\. History of immunodeficiency, including human immunodeficiency virus (HIV) positive test, or history of known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n\n10\\. History of another primary malignant tumor, with the exception of malignant tumors (e.g., basal cell carcinoma of skin and squamous cell carcinoma of skin) who have received potentially curative therapy (more than 5 years) without known active disease prior to the first dose, without potential risk for recurrence ;\n\n11\\. Toxicity of previous antitumor therapy has not been recovered to CTCTAE Grade ≤ 1 or to the level specified in the inclusion\u002Fexclusion criteria, with the exception of the following: related toxicities that are well controlled as judged by the investigator and do not affect the safety and compliance of the study treatment, and can be screened after confirmation by the Sponsor;\n\n12\\. Prior use of the following drugs or therapies before the first dose:\n\n1. Having received chemotherapy, immunotherapy or other anti-tumor therapy or other investigational drug within 21 days prior to the first dose, or having received oral fluorouracil, small-molecule targeted drugs or Chinese herbal products for antitumor indications within 14 days prior to the first dose;\n2. Major surgery, radiation therapy (with the exception of palliative radiation to a localized bone or brain lesion, which may be completed up to 14 days prior), or any other minor surgical procedure, excluding placement of vascular access devices, within 28 days prior to the first dose; and any biopsy or other minor procedure within 7 days prior to the first dose.\n3. In the combination therapy phase, patients who have received systemic treatment with corticosteroids (more than 10 mg\u002Fday prednisone or equivalent) or other immunosuppressants within 2 weeks prior to the first dose are allowed to use inhaled or topical steroids or systemic prednisone ≤10 mg\u002Fday and equivalent drug product;\n4. Having received any live vaccine or attenuated live vaccine within 28 days prior to the first dose or requiring to be vaccinated with live vaccine or attenuated live vaccine during the study (only for patients in combination therapy phase);\n\n   13\\. Patients who, in the opinion of the investigator, may be at increased risk of participation in the study due to other serious physical or mental diseases or abnormal laboratory examination, or may affect the compliance with treatment or interfere with the study results, and are not suitable for participation in this study.",{"count":339,"type":21},93,[24],"This study is an open-label, dose-escalation and expansion, Phase I clinical study to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of WJ47156 monotherapy and in combination with toripalimab in patients with advanced malignant solid tumors. The study consists of two parts, including monotherapy (Part 1) and combination therapy (Part 2).",[28],[75],"2025-02-19",{"date":346,"type":33},"2025-02-21",{"date":348,"type":33},"2024-10-23",{"date":350,"type":21},"2027-04-30",{"name":163,"class":67},{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":373},"100551743","phase-1-a-study-of-gq1010-in-subjects-with-advanced-solid-tumors-100551743","NCT06464055","A Study of GQ1010 in Subjects With Advanced Solid Tumors","A Phase I\u002FII, Multicenter, Open-Label, Dose-Escalation and Extension Study of GQ1010(an Anti-Trop2 ADC) in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female, ≥18 years old.\n2. Is able to provide written informed consent and is willing and able to comply with the protocol prior to initiation of any study-related tests or procedures.\n3. Has a life expectancy of ≥ 3 months.\n4. With histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors with epithelial derived malignancy has relapsed or progressed following local standard treatments, or for which no standard treatment is available. Priority for inclusion but not limited to the following types of cancer: gastric adenocarcinoma\u002Fgastroesophageal junction cancer, breast cancer (triple negative and hormone receptor-positive, HER2 negative), colorectal cancer, cholangiocarcinoma, pancreatic cancer, endometrial cancer, ovarian cancer, cervical cancer, etc.\n5. Agreed to provide archived tumor tissue specimens (unstained 10 surgical specimens \\[thickness 4-5μm\\] was suggested or fresh tissue samples of primary or metastatic sites within 3 years.\n\n   Note: Trop-2 expression was not used to confirm participant eligibility; Tissue samples will be used for subsequent analysis of Trop-2 expression levels and other biomarkers.\n6. Measurable tumor lesion based on Response Evaluation Criteria in Solids Tumors (RECIST) version 1.1.\n7. Subjects had confirmed disease progression during or after the most recent treatment for locally advanced or metastatic disease, or subjects would not benefit from the former treatment assessed by the investigator .\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n9. If of reproductive\u002Fchild-bearing potential(male and female) must agree to use reliable contraceptive measures (include hormonal contraceptives, barrier contraception or abstinence) with their partners during and upon completion of the study and for at least 7 months after the last dose of study drug.\n10. Has adequate bone marrow reserve and organ function (no transfusion or hematopoietic-stimulating factor therapy within 14 days):\n\n    * Hemoglobin (HGB) ≥ 9 g\u002Fdl\n    * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm3,\n    * Platelet count (PLT) ≥ 100,000\u002Fmm3,.\n    * Serum creatinine ≤ 1.5 × ULN or creatinine clearance (Ccr) ≥ 50 ml\u002Fmin (calculated according to the cockcroft-gault formula),\n    * Total bilirubin (TBIL) ≤ 1.5 × ULN (gilbert's syndrome, TBIL ≤ 3 × ULN),\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN (with liver metastases ≤ 5.0 × ULN)\n    * International normalized ratio of prothrombin (INR) ≤ 1.5 × ULN, or prothrombin time (PT) ≤ 1.5 × ULN,\n    * Activated partial thromboplastin time (APTT) ≤1.5 × ULN. Subjects receiving anticoagulant therapy must have INR and\u002For APTT≤ the upper limit of the therapeutic range intended for use,\n    * Left ventricular ejection fraction ≥50% by echocardiography\n11. Has an adequate treatment washout period prior to initial treatment.\n12. 3a: Has a pathologically documented HER2 negative (IHC 2+ and ISH\\* - or ISH unknown, or IHC 1+) advanced\u002Funresectable or metastatic gastric adenocarcinoma\u002Fgastroesophageal junction carcinoma(GC\u002FGJC) that relapsed or progressed after standard therapy (at least first-line chemotherapy with or without immune checkpoint inhibitor), or no standard therapy available. Those who relapsed\u002Fprogressed within 6 months of prior adjuvant\u002Fneoadjuvant systemic therapy are not required to receive an additional line of therapy in order to be eligible.\n13. 3b: Has a pathologically documented advanced\u002Funresectable or metastatic triple negative breast cancer(TNBC) that relapsed or progressed after standard treatment (at least first-line chemotherapy), or no standard treatment available. Subjects with HER2 low expression who have progressed after treatment with anti-HER2-ADC (such as T-DXd) are admitted.\n14. 3b: Has a pathologically documented advanced, or unresectable, or metastatic HER2 negative(IHC2+ with ISH\\*- or ISH unknown, or IHC1+) HR+BC, is documented refractory or resistant to standard therapy (Was previously treated with a minimum of 1 and a maximum of 4 prior lines of chemotherapy in the advanced\u002Fmetastatic setting), or no standard therapy available :\n\n    * All subjects must have previously received antitumor endocrine therapy, CDK-4\u002F6 inhibitor therapy, and taxanes;\n    * Those who relapsed\u002Fprogressed within 12 months of prior adjuvant\u002Fneoadjuvant systemic therapy are not required to receive an additional line of therapy in order to be eligible.;\n    * Subjects with HER2 low expression who have progressed after treatment with anti-HER2-ADC (such as T-DXd) are admitted.\n15. 3c: Has a pathologically documented advanced, unresectable, or metastatic colorectal cancer is documented refractory or resistant to standard treatment (at least 2 prior lines systemic therapy, including 5-FU-based chemotherapy and anti-VEGF or anti-EGFR-mAb therapy), or no standard therapy available.\n\n    • Has not progressed or relapsed within 3 months of therapy with irinotecan.\n16. 3d: Has a pathologically documented advanced\u002Funresectable or metastatic cervical cancer or endometrial cancer that relapsed or progressed after standard therapy (at least first-line chemotherapy with or without immune checkpoint inhibitor), or no standard therapy available.\n17. 3d: Pathologically documented unresectable or metastatic platinum-resistant ovarian cancer that has relapsed or progressed within 6 months of platinum-based chemotherapy, or no standard therapy available. .\n18. 3d: Pathologically documented unresectable or metastatic platinum-sensitive ovarian cancer that has relapsed or progressed at least 6 months after the most recent platinum-based chemotherapy , or no standard therapy available. .\n19. 3e: Has a pathologically documented advanced\u002Funresectable or metastatic Biliary tract carcinoma(BTC) that relapsed or progressed after standard therapy (at least first-line chemotherapy with or without immune checkpoint inhibitor), or no standard therapy available.\n20. 3e: Has a pathologically documented unresectable or metastatic Head and neck squamous cell carcinoma(HNSCC) that relapsed or progressed after at least 1 prior lines of therapy including chemotherapy and ICI or EGFR mAb (in combination or sequential ), or no standard therapy available.\n21. 3e: Has a pathologically documented unresectable or metastatic pancreatic cancer that relapsed or progressed after least 1 prior line of systemic therapy, or no standard therapy available. Those who relapsed\u002Fprogressed within 6 months of prior adjuvant\u002Fneoadjuvant systemic therapy are not required to receive an additional line of therapy in order to be eligible. And has not progressed or relapsed within 3 months of therapy with irinotecan.\n\nExclusion Criteria:\n\n1. Is a lactating mother or pregnant as confirmed by pregnancy tests;\n2. Clinically significant concurrent diseases, including but not limited to:\n\n   * Heart failure with New York Heart Association \\[NYHA\\] Grade II to IV\n   * Myocardial infarction, unstable angina pectoris, or stroke within 6 months prior to the first dose of study drug\n   * Newly diagnosed thromboembolic events requiring therapeutic intervention within 6 months prior to the first dose of study drug\n   * Severe aortic stenosis\n   * Uncontrolled arrhythmia\n   * Congenital long QT syndrome\n   * Prolonged QT interval (QTcF) as corrected by Fredericia \\> 470 msec according to 12-lead ECG\n   * Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and\u002For diastolic blood pressure ≥110 mmHg) or diabetes (HbA1c ≥9.0%)\n   * Clinically significant active infection requiring systemic antibiotic, antiviral, or antifungal treatment\n   * Poorly controlled pleural effusion, pericardial effusion, or ascites with clinical symptoms requiring drainage (poorly controlled as carrying a drainage tube or drainage frequency ≥1 \u002F week).;\n3. Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Has leptomeningeal carcinomatosis, has brain stem metastasis, spinal cord compression. A minimum of 4 weeks must have elapsed between the end of whole brain surgery and study enrollment. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of chemotherapy or radiotherapy.\n4. Subjects have had other primary malignancies within the last 3 years (other than sufficiently resected non-melanoma skin cancer, cured in situ disease, cured other solid tumors, and\u002For contralateral breast cancer).\n5. Has a history of or currently have interstitial lung disease (including but not limited to pulmonary fibrosis, radiation pneumonia) that requires steroids, or cannot be ruled out by imaging; Patients who currently have active pneumonia or pulmonary function tests that confirm severe impairment of lung function, and patients who require oxygen inhalation.\n6. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.), or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, Rheumatoid arthritis, Sjögren's, sarcoidosis etc.), or prior pneumonectomy.\n7. Participants who are active or have a clear history of inflammatory bowel disease, or who have esophageal and gastric varices, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose of study drug;\n8. Imaging (CT or MRI) confirmed that the tumor surrounds important blood vessels or the investigator determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;\n9. Has an active hepatitis C (HCV antibody positive with HCV RNA above the reference limit) or hepatitis B virus infection (e.g., hepatitis B surface antigen \\[HBsAg\\] positive with HBV DNA≥2000 IU\u002FmL); tuberculosis (evidence of active TB infection within 1 year), syphilis (positive for both specific and non-specific antibodies to treponema pallidum); people infected with human immunodeficiency virus (HIV positive).\n10. Grade 2 or above corneal disease with clinical symptoms.\n11. Previously received Trop-2 targeted therapy, including Trop-2 ADC.\n12. Previously received ADC therapy with topoisomerase I inhibitors as payload (HR+HER2-BC and TNBC cohort excepted).\n13. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia, chemotherapy-induced grade 2 neuropathy, endocrinopathies which can be well controlled by hormone replacement therapy and other toxicities that remained grade 2 but chronically stable evaluated by the investigator ) not yet resolved to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, Grade ≤1 or baseline.\n14. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of GQ1010. Has a history of severe hypersensitivity reaction to other monoclonal antibodies.\n15. Has any other past or current evidence of any concomitant disease, treatment, or laboratory test abnormality that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the investigator.\n16. Nucleic acid test positive for acute severe respiratory syndrome coronavirus type 2 (SARS-CoV-2) within 30 days prior to the first administration of the study drug.\n17. Administered live vaccine within 30 days prior to the first administration of the study drug.",{"count":360,"type":21},260,[24,25],"This is an open-label, phase I\u002FII study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of GQ1010 and preliminary anti-tumor efficacy in advanced malignant solid tumor subjects",[28],"2025-02-05",{"date":366,"type":33},"2025-02-10",{"date":368,"type":33},"2024-05-23",{"date":370,"type":21},"2028-12-31",{"name":372,"class":40},"GeneQuantum Healthcare (Suzhou) Co., Ltd.",5,{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":381,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":68},"100572048","phase-1-a-clinical-research-about-cd70-targeted-car-nkt-cells-therapy-in-subjects-with-advanced-malignant-solid-tumors-100572048","NCT06728189","A Clinical Research About CD70-targeted CAR-NKT Cells Therapy in Subjects with Advanced Malignant Solid Tumors","A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects with Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age 18 to 75 years.\n2. ECOG 0-1 points.\n3. The expected survival time is more than 3 months.\n4. Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.\n5. IHC: CD70 positive.\n6. At least one measurable lesion at baseline per RECIST version 1.1.\n7. The functions of important organs are basically normal:\n8. Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.\n9. Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.\n\nExclusion Criteria:\n\n1. Use of cell therapy within the previous one month.\n2. Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.\n3. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.\n4. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.\n5. Active hepatitis B, HIV positive and HCV positive.\n6. Active infection or uncontrollable infection.\n7. Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standard therapy requiring special treatment, previous history of myocarditis, or myocardial infarction within 6 months.\n8. Unstable respiratory diseases, including interstitial pneumonia.\n9. Uncontrolled ascites and pleural effusion\n10. Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .\n11. Subjects who are using systemic steroids or steroid inhalers for treatment.\n12. Pregnant or lactating female subjects.\n13. Other investigators deem it unsuitable to participate in the study.",{"count":382,"type":21},13,[24],"This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced malignant solid tumors.\n\nCondition or disease：advanced malignant solid tumors Intervention\u002Ftreatment：Biological: CD70 CAR-NKT cells Phase：Phase 1",[28],"2024-12-10",{"date":388,"type":33},"2024-12-11",{"date":390,"type":33},"2024-11-14",{"date":392,"type":21},"2026-10-17",{"name":394,"class":67},"Peking University Cancer Hospital & Institute",{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":234},"100498721","phase-1-a-clinical-study-of-9mw2821-in-advanced-malignant-solid-tumors-100498721","NCT05773937","A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors","A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n* Male or female subjects aged 18 to 80 years (including 18 and 80 years).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Phase Ia：Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). Phase Ib：Only local advanced or metastatic UC tumors.\n* Subjects must have received ICIs or GC\u002FGP therapies in the previous treatment.\n* Subjects must submit tumor tissues for test.\n* Life expectancy of ≥ 3 months.\n* Subjects must have measurable disease according to RECIST (version 1.1).\n* Adequate organ functions.\n* Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n* Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n* Chemotherapy、radiotherapy or immunotherpy within 14 days prior to the first dose of study drug.\n* Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).\n* Major surgery within 28 days prior to first dose of study drug.\n* History of uncontrolled diabetes mellitus.\n* Preexisting peripheral neuropathy Grade ≥ 2.\n* Received treatment of ADCs with MMAE payload.\n* Any live vaccines within 4 weeks before first dose of study drug or during the study.\n* Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.\n* Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.\n* Uncontrolled central nervous system metastases.\n* History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.\n* History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.\n* Has ocular conditions that may increase the risk of corneal epithelium damage.\n* Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.\n* Any P-glycoprotein (P-gp) inducers\u002Finhibitors or CYP3A4 inducers\u002Finhibitors for high and medium effect within 14 days prior to the first dose of study drug.\n* Use of any investigational drug or device within 30 days prior to the first dose of study drug.\n* Conditions or situations which may put the subject at significant risk.","80 Years",{"count":404,"type":21},40,[24],"This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.",[28],"2024-09-09",{"date":410,"type":33},"2024-09-19",{"date":412,"type":33},"2022-06-21",{"date":414,"type":21},"2024-12-31",{"name":416,"class":40},"Mabwell (Shanghai) Bioscience Co., Ltd.",{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":424,"targetDuration":4,"studyType":22,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":435,"locationsCount":68},"100507360","phase-1-a-study-of-hmpl-415s1-in-patients-with-advanced-malignant-solid-tumors-100507360","NCT05886374","A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors","A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-415S1 in Patients With Advanced Malignant Solid Tumor","Inclusion Criteria:\n\nAll the following conditions must be met for enrollment:\n\n1. Fully understand this study and voluntarily sign the ICF;\n2. Dose escalation Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons; Dose expansion phase: Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons, carrying aberrant activating mutations in the KRAS pathway；\n3. Presence of at least one measurable lesion (RECIST 1.1 criteria);\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 point;\n5. Life expectancy ≥ 12 weeks as judged by the investigator;\n6. Male of childbearing potential and their heterosexual partners of childbearing potential must agree to use effective methods of contraception.\n\nExclusion Criteria:\n\nA patient may not participate in this study if any of the following conditions apply:\n\n1. Patients who priorly received SHP2 inhibitors;\n2. Receiving the approved systemic antitumor treatment within 4 weeks prior to the first dose, including: chemotreatment, targeted treatment, immunization treatment, biological treatment, etc. (wash-out for 2 weeks for hormone treatment or traditional chinese medicine and chinese patent medicine with clear antitumor indications);\n3. Have been in the treatment period of other interventional clinical studies (including small molecule chemicals and large molecule antibodies) within 4 weeks prior to the first dose. If participating in a non-interventional clinical study (eg, epidemiological study), you can enroll in this study; if already in the survival follow-up period of an interventional clinical study, you can enroll in this study.\n4. Major surgery or radical radiotreatment (except palliative radiotreatment for metastases to bone lesions) within 4 weeks prior to first dose.\n5. Central nervous system (CNS) malignant tumor or known CNS metastasis;\n6. Having multiple factors that affect the absorption, distribution, metabolism or excretion of orally administered drugs (such as inability to swallow drugs, frequent vomiting, chronic diarrhoea, etc.);\n7. Any other disease, metabolic abnormality, physical examination abnormal, or clinically significant laboratory test abnormality that, in the judgment of the investigator, would compromise patient compliance or give reason to suspect that the patient has a disease or condition that would compromise the interpretation of study results or place the patient at high risk.",{"count":425,"type":21},81,[24],"The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-415S1 and determine MTD and\u002For RP2D in patients with advanced malignant solid tumor.",[28],"2023-07-19",{"date":431,"type":33},"2023-07-21",{"date":433,"type":33},"2023-07-06",{"date":35,"type":21},{"name":436,"class":40},"Hutchmed"]