[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562196":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":19,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":19,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":19,"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},"Arms","EXPERIMENTAL","SCTB41 of different doses,IV,every 3 weeks",[13],"Drug: SCTB41",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","SCTB41",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"xiaoman zhang","CONTACT","+86-10-58628288-9134","xiaoman_zhang@sinocelltech.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":36,"coordinates":37},"Point",[38,39],113.25,23.11667,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":19,"email":45},"Ruihua Xu, Professor","13922206676","xurh@sysucc.org.cn",{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100562196","phase-1-aims-to-explore-the-safety-tolerability-and-preliminary-efficacy-of-sctb41-in-adult-patients-with-advanced-malignant-solid-tumours-100562196",false,"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.","ALL","18 Years",{"count":58,"type":59},441,"ESTIMATED","INTERVENTIONAL",[62,63],"PHASE1","PHASE2","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.",[66],"Advanced Malignant Solid Tumours","2025-01-14",{"date":69,"type":70},"2025-01-16","ACTUAL",{"date":72,"type":70},"2024-10-10",{"date":74,"type":59},"2028-04-30",{"name":5,"class":6},1]