[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598881":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":19,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":19,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Sinocelltech Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SCTB39G","EXPERIMENTAL","SCTB39G of different doses, IV",[13],"Drug: SCTB39G",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","SCTB39G,IV",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Zhe Huang","CONTACT","+86-10-58628288","zhe_huang@sinocelltech.com",[27],{"facility":28,"status":19,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Beijing Cancer Hospital","Beijing","Beijing Municipality","100412","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":19,"phoneExt":19,"email":19},"Lin Shen, MD",{"type":44,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100598881","phase-1-phase-iii-study-of-sctb39g-in-advanced-solid-tumours-100598881",false,"NCT07077252","Phase I\u002FII Study of SCTB39G in Advanced Solid Tumours","An Open Multi-center Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39G in Adult Patients With Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n* 1.Voluntarily sign the informed consent form (ICF);\n* 2.Male or female, ≥ 18 years and ≤ 70 years old;\n* 3.Survival duration more than 3 months;\n* 4.ECOG score ≤ 1 point;\n* 5.histologically or cytologically confirmed diagnosis of advanced malignant solid tumour；\n* 6.At least one measurable tumor lession according to RECIST v1.1;\n* 7.Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n* 1.Has participated in another clinical study within 4 weeks prior to the first dose;\n* 2.Other malignancies diagnosed within 1 years prior to the enrollment;\n* 3\\. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n* 4.NSCLC at high risk of bleeding; Obvious invasion of tumor into adjacent organs of esophageal lesions leads to high risk of bleeding or fistula,or participants after endotracheal stent implantation;\n* 5.Participants with portal hypertension due to portal vein tumor thrombus at risk of bleeding;\n* 6.Presence of pleural effusion, peritoneal effusion, or ascites;\n* 7.Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment\n* 8.History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n* 9.Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n* 10.History of severe allergies, severe drug allergies (including unapproved investigational drugs);\n* 11.History of organ transplantation or stem cell transplantation;\n* 12.Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n* 13.Pregnant or breastfeeding female.","ALL","18 Years","70 Years",{"count":56,"type":57},30,"ESTIMATED","INTERVENTIONAL",[60,61],"PHASE1","PHASE2","This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39G 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],"Phase I\u002F II Study of SCTB39G in Advanced Solid Tumours","NOT_YET_RECRUITING","2025-07-11",{"date":70,"type":71},"2025-07-22","ACTUAL",{"date":73,"type":57},"2025-07-28",{"date":75,"type":57},"2027-10-17",{"name":5,"class":6},1]