[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562196":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":34,"interventions":41,"overallOfficials":27,"centralContacts":46,"locations":52,"responsibleParty":72,"collaborators":27,"id":74,"slug":27,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":27,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":27,"enrollmentInfo":82,"targetDuration":27,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":27,"overallStatus":55,"whyStopped":27,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Sinocelltech Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Dose-Limiting toxicity(DLT)","Incidence of dose-limiting toxicities up to the Day 21 visit",":From Day 0 up to Day 21",{"measure":14,"description":15,"timeFrame":16},"Objective response rate (ORR)","The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1","Up to 2 years",[18,21,24],{"measure":19,"description":20,"timeFrame":16},"Disease control rate (DCR)","The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1.",{"measure":22,"description":23,"timeFrame":16},"Progression-free survival (PFS)","Progression-free survival is defined as the time from the start of treatment with SCTB41 until the first documentation ofdisease progression or death due to any cause, whichever occurs first.",{"measure":25,"description":26,"timeFrame":16},"Overall survival (OS)","Overall survival is defined as the time from the start of treatment with SCTB41 until death due to any cause.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NA","SEQUENTIAL","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"Arms","EXPERIMENTAL","SCTB41 of different doses,IV,every 3 weeks",[40],"Drug: SCTB41",[42],{"type":43,"name":44,"description":38,"armGroupLabels":45,"otherNames":27},"DRUG","SCTB41",[36],[47],{"name":48,"role":49,"phone":50,"phoneExt":27,"email":51},"xiaoman zhang","CONTACT","+86-10-58628288-9134","xiaoman_zhang@sinocelltech.com",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":62,"coordinates":63},"Point",[64,65],113.25,23.11667,{"lat":65,"lon":64},[68],{"name":69,"role":49,"phone":70,"phoneExt":27,"email":71},"Ruihua Xu, Professor","13922206676","xurh@sysucc.org.cn",{"type":73,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","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":83,"type":84},441,"ESTIMATED","INTERVENTIONAL",[87,88],"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.",[91],"Advanced Malignant Solid Tumours","2025-01-14",{"date":94,"type":95},"2025-01-16","ACTUAL",{"date":97,"type":95},"2024-10-10",{"date":99,"type":84},"2028-04-30",{"name":5,"class":6},1]