[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chiome Bioscience Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100564996","phase-1-a-phase-i-first-in-human-study-of-cba-1205-anti-dlk1-monoclonal-antibody-in-patients-with-advanced-solid-tumors-hepatocellular-carcinoma-hcc-melanoma-and-pediatric-cancer-100564996",false,"NCT06636435","A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer","A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.","Inclusion Criteria:(Part 1-4)\n\n* Patients who provide voluntary written informed consent to participate in the study\n* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1\n* Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)\n* Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: Neutrophil count;≥1500\u002FμL, Platelet count; ≥75000\u002FμL, Hemoglobin;≥9.0 g\u002FdL.\n* Patients having Solid Tumors with no standard therapy available or refractory or intolerable to standard therapy (Part2, 3)\n* Patients with Child-Pugh A or B (Part2, 3)\n* Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4)\n\nInclusion Criteria:(Part 5)\n\n* Patients who provide voluntary written informed consent to participate in the study from both the subject (if aged 16 years or older) and their legal representatives\n* Japanese patients aged 2 years or older and under 20 years at the time of informed consent\n* Patients with a Lansky Performance Status (LPS) of ≥70 (for patients aged 15 years or younger) or a Karnofsky Performance Status (KPS) of ≥70 (for patients aged 16 years or older)\n* Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (eGFR ≥60 mL\u002Fmin\u002F1.73 m²)\n* Pediatric patients with cancers with no standard therapy available or refractory or intolerable to the standard therapy\n\nExclusion criteria: (Part1-5)\n\n* Patients who have undergone major surgery within 28 days before enrollment\n* Patients who have received anticancer treatment with surgical therapy, radiation therapy, and\u002For drug therapy within 14 days before enrollment\n* Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment\n* Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity\n* Patients who have received any other investigational product within 28 days before enrollment\n* Patients with current or previous inadequately controlled or clinically significant cardiac disease\n* Patients who, in the opinion of the investigator or subinvestigator, is not appropriate","ALL","2 Years",{"count":19,"type":20},66,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.",[26,27,28,29],"Solid Tumors","Hepatocellular Carcinoma (HCC)","Malignant Melanoma","Pediatric Cancer",[31,32,33,34,35,36,37,38,29],"DLK1","First in human","Phase I","Antibody","solid tumor","Hepatocellular Carcinoma","CBA-1205","Melanoma","RECRUITING","2026-06-15",{"date":42,"type":43},"2026-06-17","ACTUAL",{"date":45,"type":43},"2020-06-01",{"date":47,"type":20},"2027-06-30",{"name":49,"class":50},"Chiome Bioscience Inc.","INDUSTRY",5,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":5},"100594250","phase-1-a-phase-i-first-in-human-study-of-cba-1535-t-cell-engager5t4cd35t4-in-patients-with-advanced-solid-tumors-100594250","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","20 Years",{"count":61,"type":20},70,[23],"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.",[26,65],"Refractory Cancer",[67,68,69,70,71,72,73],"CBA-1535","5T4","CD3","T cell Engager","Trophoblast Glycoprotein","Tribody","solid tumors","2025-06-04",{"date":76,"type":43},"2025-06-12",{"date":78,"type":43},"2022-06-27",{"date":80,"type":20},"2026-12",{"name":49,"class":50},""]