[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-malignant-solid-tumours\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-malignant-solid-tumours":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"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},"100584399","phase-1-a-phase-iii-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-initial-efficacy-of-js212-in-subjects-with-advanced-malignant-solid-tumour-100584399",false,"NCT06888830","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour","Inclusion Criteria:\n\n1. Subjects of either sex who are 18 to 75 years of age (inclusive of 18 and 75 years) at the time of signing the consent form;\n2. Histologically or cytologically confirmed advanced malignant solid tumors;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n4. Expected survival of ≥ 12 weeks;\n5. Subjects have at least 1 measurable lesion according to RECIST v1.1 criteria (without measurable lesions are allowed during dose escalation phase);\n\nExclusion Criteria:\n\n1. Presence of active central nervous system metastasis. If previous radiotherapy or surgery, etc. has been received, and the imaging examination within 4 weeks before the first dose suggests that the brain metastasis is stable without exacerbation or new neurological symptoms, and hormone therapy has been discontinued two weeks before the first dose, screening is allowed; for the presence of meningeal metastasis and brainstem metastasis, regardless of the treatment or not, screening is not allowed;\n2. Presence of clinically symptomatic pleural effusion, ascites, or pericardial effusion that requires repeated management (puncture or drainage, etc.);\n3. Presence of medically uncontrolled hypertension, or with a history of hypertensive crisis or hypertensive encephalopathy;\n4. Presence of a history of (non-infectious) interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring steroid therapy (e.g., idiopathic pulmonary fibrosis, mechanized pneumonia, drug-induced pneumonia, radiation pneumonitis, idiopathic pneumonia, etc.), and current ILD\u002Fnon-infectious pneumonia;\n5. Presence of clinically significant lung-specific co-morbidities including, but not limited to, any underlying lung disease (e.g., pulmonary embolism, severe asthma, severe COPD, restrictive lung disease, etc., diagnosed within 3 months prior to the first study dose) and any autoimmune, connective tissue, or inflammatory disease with pulmonary involvement (e.g., rheumatoid arthritis, Scheugelin's syndrome, sarcoidosis, etc.) and prior total pneumonectomy;\n6. Presence of a history of immunodeficiency, including a positive test for Human Immunodeficiency Virus (HIV), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation；\n7. the presence of other factors that may cause them to be forced to terminate the study midway, such as serious physical or mental illness or abnormal laboratory tests, which may increase the risk of participation in the study, affect treatment compliance, or interfere with the results of the study, and which, in the judgment of the investigator, make the subject unsuitable for participation in this study；","ALL","18 Years","75 Years",{"count":19,"type":20},374,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study is a Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects with Advanced Malignant Solid Tumour. Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage.",[27],"Advanced Malignant Solid Tumours","RECRUITING","2025-06-17",{"date":31,"type":32},"2025-06-19","ACTUAL",{"date":34,"type":32},"2025-04-11",{"date":36,"type":20},"2027-04-01",{"name":38,"class":39},"Shanghai Junshi Bioscience Co., Ltd.","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":40},"100562196","phase-1-aims-to-explore-the-safety-tolerability-and-preliminary-efficacy-of-sctb41-in-adult-patients-with-advanced-malignant-solid-tumours-100562196","NCT06600022","Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.","A Phase I\u002FII, Open-label, Multicentre, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCTB41 in Patients with Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. Male or female, ≥18 years old;\n3. Survival duration more than 3 months;\n4. ECOG score ≤ 1 point;\n5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;\n6. Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;\n7. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases;\n2. Other malignancies diagnosed;\n3. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment;\n4. Presence of any active autoimmune disease or a history of autoimmunedisease with an expected recurrence;\n5. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment;\n6. Need for immunosuppressive drugs within 2 weeks prior to enrollment oranticipated during the study;\n7. Significant coagulopathy or other evident risk of bleeding;\n8. uncontrolled effusions in the serous cavities within 4 weeks before enrollment；\n9. Major surgery or significant trauma within 4 weeks prior to enrollment;presence of unhealed skin wounds, surgical sites, trauma sites, severe- Page 3 of 4 \\[DRAFT\\] -mucosal ulcers, or fractures, or if the Investigator deems the participantunsuitable for the study;\n10. History of permanent discontinuation of immunotherapy due to immunerelated toxicity or occurrence of ≥ Grade 3 irAEs;\n11. Known severe allergy to similar antibody drugs;\n12. Presence of active infection；\n13. History of organ transplantation or stem cell transplantation;\n14. Pregnant or breastfeeding female; women of childbearing potential withpositive pregnancy test within 7 days before the enrollment; participants(including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.",{"count":49,"type":20},441,[23,24],"This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[27],"2025-01-14",{"date":55,"type":32},"2025-01-16",{"date":57,"type":32},"2024-10-10",{"date":59,"type":20},"2028-04-30",{"name":61,"class":62},"Sinocelltech Ltd.","INDUSTRY",{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100539513","phase-1-aims-to-explore-the-safety-tolerability-and-preliminary-efficacy-of-sctb14-in-adult-patients-with-advanced-malignant-solid-tumours-100539513","NCT06304818","Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours.","A Phase I\u002FII, Open-label, Multicentre, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCTB14 in Patients With Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. Male or female, 18 years old ≤ age ≤ 75 years old;\n3. Survival duration more than 3 months;\n4. ECOG score ≤ 1 point;\n5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;\n6. Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;\n7. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n2. Other malignancies diagnosed within 5 years prior to the enrollment, except effectively treated malignant solid tumour (such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical cancer in situ, breast cancer in situ, etc.);\n3. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollmen;\n4. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n5. Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;\n6. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n7. Significant coagulopathy or other evident risk of bleeding;\n8. Major surgery or significant trauma within 4 weeks prior to enrollment; presence of unhealed skin wounds, surgical sites, trauma sites, severe mucosal ulcers, or fractures, or if the Investigator deems the participant unsuitable for the study;\n9. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n10. History of severe allergies, severe drug allergies (including unapproved investigational drugs), or known allergy to any component of the IMP;\n11. History of organ transplantation or stem cell transplantation;\n12. Pregnant or breastfeeding female; women of childbearing potential with positive pregnancy test within 7 days before the enrollment; participants (including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.",{"count":71,"type":20},515,[23,24],"This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[27],"NOT_YET_RECRUITING","2024-03-13",{"date":78,"type":32},"2024-03-15",{"date":80,"type":20},"2024-04-30",{"date":82,"type":20},"2028-12-30",{"name":61,"class":62}]