[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596835":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":19,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":19,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":19,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Sinocelltech Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SCTB39-1","EXPERIMENTAL","SCTB39-1 of different doses, IV, every 3 weeks",[13],"Drug: SCTB39-1",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","SCTB39-1, IV",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Cuige Gao","CONTACT","+86-10-58628288","cuige_gao@sinocelltech.com",[27],{"facility":28,"status":29,"city":30,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Cancer Hospital Chinese Academy of Medical Science","RECRUITING","Beijing","China","CN",{"type":34,"coordinates":35},"Point",[36,37],116.39723,39.9075,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":42,"phoneExt":19,"email":43},"Yu Hua","+86-18810090438","tsjj0082@chncro.com",{"type":45,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100596835","phase-1-phase-iii-study-of-sctb39-1-in-advanced-solid-tumours-100596835",false,"NCT07050641","Phase I\u002FII Study of SCTB39-1 in Advanced Solid Tumours","An Open Multi-center Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39-1 in Adult Patients With Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. Male or female, over 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. At least one measurable tumor lession according to RECIST v1.1;\n8. 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. Other malignancies diagnosed within 5 years prior to the enrollment;\n3. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n4. Significant bleeding risk;\n5. Presence of pleural effusion, peritoneal effusion, or ascites;\n6. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n7. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n8. History of severe allergies, severe drug allergies (including unapproved investigational drugs);\n9. History of organ transplantation or stem cell transplantation;\n10. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n11. Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;\n12. Pregnant or breastfeeding female.","ALL","18 Years",{"count":56,"type":57},110,"ESTIMATED","INTERVENTIONAL",[60,61],"PHASE1","PHASE2","This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39-1 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.",[64],"Advanced Malignant Solid Tumor",[66],"advanced malignant solid tumor","2025-07-02",{"date":69,"type":70},"2025-07-04","ACTUAL",{"date":72,"type":70},"2025-06-23",{"date":74,"type":57},"2028-06-30",{"name":5,"class":6},1]