[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable-locally-advanced-or-metastatic-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable-locally-advanced-or-metastatic-solid-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100591006","phase-1-ibi3014-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100591006",false,"NCT06974812","IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2 Study of IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria\n\n* 1.Participants with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;\n* 2.Male or female participants ≥ 18 years old;\n* 3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;\n* 4.Anticipated life expectancy of ≥ 12 weeks;\n* 5.Participants, both male and female, who are either not of childbearing potential or who agree to use at least one highly effective method of contraception during the study (begin from screening or within 2 weeks prior to the first dose, whichever comes first, and continue until 6 months after the last dose of study drug).\n* 6.Adequate bone marrow and organ function:\n* 7.Has at least 1 measurable lesion per RECIST v1.1(at least 1 evaluable lesion for dose participants in dose escalation part);\n* 8.Not a candidate for curable surgical resection or radical chemoradiation;\n\nExclusion Criteria\n\n* 1.Drugs and other treatments to be excluded;\n* 2.Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to Investigators' opinion) prior to first administration of the study drug;\n* 3.Prior use of Camptothecin-Derived agents (e.g., irinotecan, topotecan) or immune checkpoint inhibitor and documented adverse reaction which is severe and influence the safety assessment of participants.\n* 4.Allergic or hypersensitive to other monoclonal antibodies and\u002For Camptothecin Derivative based therapy, or any ingredients of IBI3014;\n* 5.Known symptomatic central nervous system (CNS) metastases. The following conditions could be considered enrollment: Participants with asymptomatic CNS metastases (which means no neural system syndromes, no need of corticosteroids treatment and diameter of metastases ≤ 1.5cm) or confirmed stable status according to Investigators' opinion after treatment, No midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord metastasis; and stable status for at least 4 weeks without new or enlarged metastases definitively confirmed by clinical evidence, and withdrawal of corticosteroids or anticonvulsant for at least 2 weeks prior to the first administration of study drug;\n* 6.History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases (e.g. Interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease such as pulmonary fibrosis, severe radiation pneumonitis and acute lung injury) or who are suspected to have these diseases by imaging at screening period;\n* 7.Participants with a clinically significant (CS) cardiovascular disease or condition;\n* 8.Participants with a significant gastrointestinal disease or condition,\n* 9.Participants with biliary obstruction. Unless the blockage is treated locally, such as endoscopic stenting or percutaneous liver puncture and drainage, the total bilirubin is reduced below 1.5 times ULN;\n* 10.Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;\n* 11.Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis;\n* 12.Significant malnutrition, such as the need for intravenous fluids; Malnutrition corrected for more than 4 weeks prior to the first administration of study drug is allowed;\n* 13.Tumor invasion of surrounding important structures (such as mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal\u002Frespiratory fistula;\n* 14.Uncontrolled or clinically significant infections\n* 15.History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases;\n* 16.Had a history of organ transplantation, allogeneic bone marrow transplantation or hematopoietic stem cell transplantation;\n* 17.Other uncontrolled active disease or acute or chronic diseases or abnormal laboratory test that may: increase risk of study participation or study drug administration, interfere with the interpretation of study results, and, disqualify the participant for study participation in the Investigator's judgment;\n* 18.History of other primary malignant tumors;\n* 19.Women who are considered pregnant or are lactating;\n* 20.Under neurological, psychiatric disorder or social condition that affects compliance with study requirements, significantly increases the risk of adverse events, or affects participants' ability to provide written informed consent;","ALL","18 Years",{"count":19,"type":20},250,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a phase 1\u002F2 multicenter, multi-regional, open-label, first-in-human study of IBI3014 in participants with unresectable locally advanced or metastatic solid tumors.",[27],"Unresectable Locally Advanced or Metastatic Solid Tumors","RECRUITING","2026-01-26",{"date":31,"type":32},"2026-01-29","ACTUAL",{"date":34,"type":32},"2025-04-18",{"date":36,"type":20},"2027-06-30",{"name":38,"class":39},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100568544","phase-1-safety-and-efficacy-of-syha1813-single-agent-or-in-combination-with-different-regimens-in-unresectable-locally-advanced-or-metastatic-solid-tumors-100568544","NCT06682611","Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.","An, Phase Ib\u002FII Clinical Trial to Evaluate the Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.","Inclusion Criteria:\n\n1. Aged \\>= 18 years;\n2. Unresectable locally advanced or metastatic solid tumors confirmed by histology or cytology:\n3. There is at least one measurable lesion in the baseline period (RECIST1.1);\n4. ECOG PS of 0-1;\n5. The expected survival time is \\>=3 months;\n6. The organ function level and related laboratory indicators must meet the following requirements (No blood transfusion or hematopoietic stimulating factor therapy received within 14 days prior to the first medication (queue 1 to 6)\u002Fprior to randomization (queue 7 and queue 8):\n\n   ANC≥1.5×10\\^9\u002FL； PLT≥100×10\\^9\u002FL（Liver cancer patients PLT≥75×10\\^9\u002FL）； Hb≥90 g\u002FL； TBIL≤1.5×ULN，and for Gilbert's syndrome, liver cancer or liver metastasis patients TBIL≤3×ULN； ALT和AST≤2.5×ULN，for liver cancer or liver metastasis patients ≤5×ULN； Child-Pugh Grade A (only applicable to queue 8)； ALB≥30 g\u002FL； Cr≤1.5×ULN，IF Cr\\>1.5×ULN，Ccr≥60 mL\u002Fmin（Cockcroft-Gault）is required； APTT and INR≤1.5×ULN\n7. The subjects must agree to take medically approved contraceptive measures for at least 6 months from the beginning of the study to the last dose of drug.\n\nExclusion Criteria:\n\n1. Patients who are known or suspected to be allergic to the test drug or its components;\n2. Excluding the disease studied in this trial, there are other primary malignant tumors that have progressed or require treatment within the past 3 years prior to screening (except for effectively controlled skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer or cured breast carcinoma in situ);\n3. The toxicity of previous anti-tumor treatments has not recovered (≤grode 1), except for hair loss and other adverse reactions judged by the investigator that do not affect the safety of the study medication;\n4. Active leptomeningeal disease or CNS metastases that are not well controlled;\n5. Uncontrollable active infections occurred within 14 days prior to the first medication (queue 1 to 6)\u002Fprior to randomization (queue 7 and queue 8), requiring systemic treatment with intravenous antibiotic infusion\n6. Patients with evidence of bleeding tendency or medical history within 28 days;\n7. Patients have risk factors for intestinal obstruction or intestinal perforation;\n8. The subject has poorly healed wounds, ulcers or fractures;\n9. Urine protein ≥ 2+, and 24-hour urine protein quantitative ≥ 1.0g\u002F24h;\n10. Patients have large pleural effusions, pericardial effusions, or abdominopelvic effusions;\n11. Human immunodeficiency virus (HIV) antibody positive; active hepatitis C, with antibody positive and HCV RNA test positive; active hepatitis B, with HBsAg positive, and HBV-DNA value\\>500 IU\u002Fml or 2500 copies\u002FmL;\n12. Has a history of active tuberculosis;\n13. History of interstitial lung disease (except for radiotherapy-induced focal interstitial pneumonia), noninfectious pneumonitis requiring glucocorticoid therapy;\n14. Received immunosuppressants such as PD-1 or PD-L1 inhibitors in the recurrent or metastatic phase (only for Cohort 1);\n15. Prior treatment with a VEGFR-TKI inhibitor or other anti-angiogenic agent (except for Cohort 5,7,8);\n16. Pregnant or lactating women;\n17. Participants who may have poor compliance as judged by the investigator, such as a clear history of neurological or psychiatric disorders (including epilepsy or dementia), current psychiatric disorders, psychotropic drug abuse, etc.;",{"count":49,"type":20},380,[23,24],"This is an open-label, multi-center, multi-cohort, phase Ib\u002FII clinical trial, divided into 8 cohorts according to tumor types. Cohorts 1-4 are SYHA1813 combined with different regimens, including safety run-in stage and cohort expansion stage. Cohorts 5-8 are SYHA1813 monotherapy and only include the expansion cohorts. The primary objective was to evaluate the safety and efficacy of SYHA1813 single agent or in combination with different regimens in unresectable locally advanced or metastatic solid tumors.",[27],"NOT_YET_RECRUITING","2024-11-08",{"date":56,"type":32},"2024-11-12",{"date":58,"type":20},"2024-11-13",{"date":60,"type":20},"2027-11-13",{"name":62,"class":39},"Shanghai Runshi Pharmaceutical Technology Co., Ltd"]