[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638178":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":18,"responsibleParty":30,"collaborators":18,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":18,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":18,"studyType":45,"phases":46,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":54,"whyStopped":18,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":18},{"fullName":5,"class":6},"Sinocelltech Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SCTB41+SCTB39-1","EXPERIMENTAL","SCTB41 plus SCTB39-1 of different doses, IV, every 3 weeks",[13],"Drug: SCTB41+SCTB39-1",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20],{"name":21,"affiliation":22,"role":23},"jiang","Cancer Hospital Chinese Academy of Medical Science Recruiting Beijing, China","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Dongyang Gao, Doctor","CONTACT","+86-010-58628288","dongyang_gao@sinocelltech.com",{"type":31,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100638178","phase-1-phase-iii-study-of-sctb41-plus-sctb39-1with-or-without-standard-therapy-in-advanced-solid-tumours-100638178",false,"NCT07594028","Phase I\u002FII Study of SCTB41 Plus SCTB39-1with or Without Standard Therapy in Advanced Solid Tumours","An Open Multi-center Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB41 in Combination With SCTB39-1With or Without Standard Therapy in Adult Patients With Advanced Malignant Solid Tumours","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 tumour；\n6. At least one measurable tumor lession 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":43,"type":44},126,"ESTIMATED","INTERVENTIONAL",[47,48],"PHASE1","PHASE2","This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 in combination with SCTB39-1with or without standard therapy 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.",[51],"Advanced Malignant Solid Tumor",[53],"advanced malignant solid tumor","NOT_YET_RECRUITING","2026-05-11",{"date":57,"type":58},"2026-05-18","ACTUAL",{"date":60,"type":44},"2026-05-30",{"date":62,"type":44},"2029-05-30",{"name":5,"class":6}]