[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594250":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":47,"collaborators":25,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":25,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":25,"enrollmentInfo":58,"targetDuration":25,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Chiome Bioscience Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: CBA-1535 (single agent therapy)","EXPERIMENTAL","Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 of each 21-day cycle.",[13],"Drug: CBA-1535",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2: CBA-1535+Pembrolizumab","Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 , and Pembrolizumab as Q3W IV infusion at fix dose on Day 1 of each 21-day cycle.",[18],"Drug: CBA-1535+Pembrolizumab",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","CBA-1535","Dosing is increased from 0.1 µg\u002Fbody until DLT or disease progression occurs.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"CBA-1535+Pembrolizumab","Drug：CBA-1535 First Dosing will be determined by Part 1. And dosing will be increased until DLT or disease progression occurs.\n\nDrug：Pembrolizumab 200 mg\u002Fbody",[15],[31],{"name":5,"role":32,"phone":33,"phoneExt":25,"email":34},"CONTACT","+81-3-6383-3561","ir@chiome.co.jp",[36,43],{"facility":37,"status":38,"city":39,"state":40,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Shizuoka Cancer Center","RECRUITING","Nagaizumicho","Shizuoka","Japan","JP",{"facility":44,"status":38,"city":45,"state":46,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"National Cancer Center Hospital","Chuo-Ku","Tokyo",{"type":48,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100594250","phase-1-a-phase-i-first-in-human-study-of-cba-1535-t-cell-engager5t4cd35t4-in-patients-with-advanced-solid-tumors-100594250",false,"NCT07016997","A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4\u002FCD3\u002F5T4) in Patients With Advanced Solid Tumors.","A Phase I Study to Assess the Safety, Tolerability and Biomarker Profiles of CBA-1535, Recombinant Protein Tribody in Patients With Previously Treated Advanced Solid Tumors.","Inclusion Criteria:\n\n* Patients who provide voluntary written informed consent to participate in the study\n* ECOG performance status: \\\u003C= 1\n* Patients with 3 months or longer life expectancy\n* Patients with solid tumors for whom no standard therapy is available or who are refractory to or intolerant of standard therapy\n\nExclusion Criteria:\n\n* Patients who received other investigational drug or antibody drugs, including immune checkpoint inhibitor within 28 days prior to enrollment\n* Patients who received anti-cancer drug within 14 days prior to enrollment\n* Patients with previous or suspected hypersensitivity to protein preparations such as therapeutic antibodies (Chinese hamster ovary cell-derived drugs) or any component of the study drug","ALL","20 Years",{"count":59,"type":60},70,"ESTIMATED","INTERVENTIONAL",[63],"PHASE1","This is a First in Human muticenter, non-randomized, open-label Phase I dose-escalation study of CBA-1535.\n\nThe study will have 2 parts (Part 1 and Part 2). Part 1 is the dose-escalation cohorts of CBA-1535 single agent theapy. Part 2 is the dose-escalation cohorts of CBA-1535 in combination with Pembrlizumab.\n\nThis study will evaluate the safety, tolerability, PK, biomarker profiles and preliminary efficacy of CBA-1535.",[66,67],"Solid Tumors","Refractory Cancer",[22,69,70,71,72,73,74],"5T4","CD3","T cell Engager","Trophoblast Glycoprotein","Tribody","solid tumors","2025-06-04",{"date":77,"type":78},"2025-06-12","ACTUAL",{"date":80,"type":78},"2022-06-27",{"date":82,"type":60},"2026-12",{"name":5,"class":6},2]