[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564996":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":40,"centralContacts":57,"locations":65,"responsibleParty":118,"collaborators":40,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":40,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":40,"enrollmentInfo":129,"targetDuration":40,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":141,"overallStatus":68,"whyStopped":40,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Chiome Bioscience Inc.","INDUSTRY",[8,14,19,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"CBA-1205: Part 1","EXPERIMENTAL","CBA-1205 injection is administered at 2-week intervals in seven cohorts (0.1, 0.3, 1, 3, 10, 20, 30 mg\u002Fkg) in patients with solid tumor.\n\nNote: In the study treatment period, CBA-1205 is intravenously administered at 2-week intervals in a 28-day cycle.",[13],"Drug: CBA-1205 Part 1",{"label":15,"type":10,"description":16,"interventionNames":17},"CBA-1205: Part 2","CBA-1205 (20, 30 mg\u002Fkg) injection is administered at 2-week intervals in 28-day cycles in patients with HCC .\n\nNote: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.",[18],"Drug: CBA-1205 Part 2",{"label":20,"type":10,"description":21,"interventionNames":22},"CBA-1205: Part 3","CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with HCC.\n\nNote: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.",[23],"Drug: CBA-1205 Part 3",{"label":25,"type":10,"description":26,"interventionNames":27},"CBA-1205 : Part 4","CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Malignant Melanoma.\n\nNote: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.",[28],"Drug: CBA-1205 Part 4",{"label":30,"type":10,"description":31,"interventionNames":32},"CBA-1205: Part 5","CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Pediatric Cancer.\n\nNote: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.",[33],"Drug: CBA-1205 Part 5",[35,41,45,49,53],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","CBA-1205 Part 1","CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg\u002Fkg (Intravenous solution)",[9],null,{"type":36,"name":42,"description":43,"armGroupLabels":44,"otherNames":40},"CBA-1205 Part 2","CBA-1205: 20 mg\u002Fkg and 30 mg\u002Fkg (Intravenous solution)",[15],{"type":36,"name":46,"description":47,"armGroupLabels":48,"otherNames":40},"CBA-1205 Part 3","CBA-1205: 30 mg\u002Fkg (Intravenous solution)",[20],{"type":36,"name":50,"description":51,"armGroupLabels":52,"otherNames":40},"CBA-1205 Part 4","CBA-1205: 20 mg\u002Fkg (Intravenous solution)",[25],{"type":36,"name":54,"description":55,"armGroupLabels":56,"otherNames":40},"CBA-1205 Part 5","CBA-1205: 10 mg\u002Fkg (The initial cohort, Intravenous solution)",[30],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":40,"email":62},"Tanaka Miseri Chiome Bioscience Inc.","CONTACT","+81-3-6383-3561","ir@chiome.co.jp",{"name":64,"role":60,"phone":61,"phoneExt":40,"email":40},"General Affairs and Human Resources Department Chiome Bioscience Inc.",[66,80,90,99,109],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":40},"National Cancer Center Hospital East","RECRUITING","Kashiwa","Chiba","277-8577","Japan","JP",{"type":75,"coordinates":76},"Point",[77,78],139.97732,35.86224,{"lat":78,"lon":77},{"facility":81,"status":68,"city":82,"state":83,"zip":84,"country":72,"countryCode":73,"cosmosGeoPoint":85,"geoPoint":89,"contacts":40},"Kanagawa Cancer Center","Yokohama","Kanagawa","241-8515",{"type":75,"coordinates":86},[87,88],139.65,35.43333,{"lat":88,"lon":87},{"facility":91,"status":68,"city":92,"state":92,"zip":93,"country":72,"countryCode":73,"cosmosGeoPoint":94,"geoPoint":98,"contacts":40},"Niigata University Medical and Dental Hospital","Niigata","951-8520",{"type":75,"coordinates":95},[96,97],139.04125,37.92259,{"lat":97,"lon":96},{"facility":100,"status":68,"city":101,"state":102,"zip":103,"country":72,"countryCode":73,"cosmosGeoPoint":104,"geoPoint":108,"contacts":40},"National Cancer Center Hospital","Chūō","Tokyo","104-0045",{"type":75,"coordinates":105},[106,107],139.77544,35.67004,{"lat":107,"lon":106},{"facility":110,"status":68,"city":101,"state":111,"zip":112,"country":72,"countryCode":73,"cosmosGeoPoint":113,"geoPoint":117,"contacts":40},"University of Yamanashi Hospital","Yamanashi","409-3898",{"type":75,"coordinates":114},[115,116],138.50275,35.59465,{"lat":116,"lon":115},{"type":119,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","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":130,"type":131},66,"ESTIMATED","INTERVENTIONAL",[134],"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.",[137,138,139,140],"Solid Tumors","Hepatocellular Carcinoma (HCC)","Malignant Melanoma","Pediatric Cancer",[142,143,144,145,146,147,148,149,140],"DLK1","First in human","Phase I","Antibody","solid tumor","Hepatocellular Carcinoma","CBA-1205","Melanoma","2026-06-15",{"date":152,"type":153},"2026-06-17","ACTUAL",{"date":155,"type":153},"2020-06-01",{"date":157,"type":131},"2027-06-30",{"name":5,"class":6},5]