Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-02 @ 12:18 PM
Study NCT ID:
NCT06636435
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2024-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2024-09-30', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploration of biomarkers:', 'timeFrame': 'Baseline through disease progression assessed (Maximum 12 months.)', 'description': 'Exploration of biomarkers:\n\nDelta-like 1 homolog (DLK1)-related marker'}], 'primaryOutcomes': [{'measure': 'Dose limiting toxicity', 'timeFrame': 'Part 1, 2 and 5 - Dose limiting toxicity : For 28 days after the first dose of study treatment', 'description': 'DLTs are assessed according to CTCAE v.5.0 during the first cycle (28 days).'}, {'measure': 'Adverse Event', 'timeFrame': 'Adverse event : Maximum 12 months', 'description': 'An adverse event is any untoward or unintended sign, symptom, or disease in a subject administered an investigational product, whether or not it is related to the investigational product'}], 'secondaryOutcomes': [{'measure': 'Serum CBA-1205 concentration', 'timeFrame': 'From Day 1 to Day 43 (or until Discontiuation of treatment)', 'description': 'Blood samples are collected to assess the serum concentration of CBA-1205.'}, {'measure': 'Immunogenicity', 'timeFrame': 'From Day1 to Day 43 (or until Discontiuation of treatment)', 'description': 'Blood samples are collected to assess the serum anti-CBA-1205 antibody.'}, {'measure': 'Efficacy', 'timeFrame': 'Screening, Day 1 of Cycle 2 and 3, and Day 1 of even-numbered cycles from Cycle 4 onward until treatment discontinuation. Maximum 12 months', 'description': 'Antitumor response evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n\nTumor markers'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DLK1', 'First in human', 'Phase I', 'Antibody', 'solid tumor', 'Hepatocellular Carcinoma', 'CBA-1205', 'Melanoma', 'Pediatric Cancer'], 'conditions': ['Solid Tumors', 'Hepatocellular Carcinoma (HCC)', 'Malignant Melanoma', 'Pediatric Cancer']}, 'referencesModule': {'references': [{'pmid': '39769389', 'type': 'BACKGROUND', 'citation': 'Nakamura K, Takahashi K, Sakaguchi I, Satoh T, Zhang L, Yanai H, Tsukumo Y. A Novel Glycoengineered Humanized Antibody Targeting DLK1 Exhibits Potent Anti-Tumor Activity in DLK1-Expressing Liver Cancer Cell Xenograft Models. Int J Mol Sci. 2024 Dec 19;25(24):13627. doi: 10.3390/ijms252413627.'}, {'pmid': '39832211', 'type': 'BACKGROUND', 'citation': 'Katsuya Y, Ikeda M, Koyama T, Sato J, Okada M, Matsubara N, Kondoh C, Mukohara T, Watanabe K, Kotani D, Ogawa Y, Taoka S, Yamamoto N. A Phase I, First-In-Human Study of CBA-1205, an Anti-DLK1 Monoclonal Antibody, in Patients With Advanced Solid Tumors. Cancer Sci. 2025 Apr;116(4):1012-1022. doi: 10.1111/cas.16454. Epub 2025 Jan 20.'}], 'seeAlsoLinks': [{'url': 'https://www.chiome.co.jp/?id=en', 'label': 'Sponsor Page'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'To evaluate safety and efficacy of CBA-1205 in the following five parts in a stepwise manner:\n\nPart 1\n\n* In Part 1, safety and tolerability in patients with Solid Tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated. Initial dose for Part 2 will be determined.\n\nPart 2\n\n* In Part 2, safety and tolerability in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. Recommended dose in this population will be determined.\n\nPart 3\n\n* In Part 3, safety and efficacy at the recommended dose in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated.\n\nPart 4\n\n* In Part 4, safety and efficacy in patients with Malignant Melanoma who are refractory or intolerant to standard therapy.\n\nPart 5\n\n* In Part 5, safety, tolerability and the recommended dose of the study drug in patients with Pediatric Cancer where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated.\n\nPK analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/μL, Platelet count; ≥75000/μL, Hemoglobin;≥9.0 g/dL.\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/min/1.73 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/or 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'}, 'identificationModule': {'nctId': 'NCT06636435', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiome Bioscience Inc.'}, 'officialTitle': 'A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.', 'orgStudyIdInfo': {'id': '1205-001'}, 'secondaryIdInfos': [{'id': 'jRCT2080225288', 'type': 'OTHER', 'domain': 'Japan Registry of Clinical Trials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBA-1205: Part 1', 'description': 'CBA-1205 injection is administered at 2-week intervals in seven cohorts (0.1, 0.3, 1, 3, 10, 20, 30 mg/kg) 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.', 'interventionNames': ['Drug: CBA-1205 Part 1']}, {'type': 'EXPERIMENTAL', 'label': 'CBA-1205: Part 2', 'description': 'CBA-1205 (20, 30 mg/kg) 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.', 'interventionNames': ['Drug: CBA-1205 Part 2']}, {'type': 'EXPERIMENTAL', 'label': 'CBA-1205: Part 3', 'description': '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.', 'interventionNames': ['Drug: CBA-1205 Part 3']}, {'type': 'EXPERIMENTAL', 'label': 'CBA-1205 : Part 4', 'description': '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.', 'interventionNames': ['Drug: CBA-1205 Part 4']}, {'type': 'EXPERIMENTAL', 'label': 'CBA-1205: Part 5', 'description': '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.', 'interventionNames': ['Drug: CBA-1205 Part 5']}], 'interventions': [{'name': 'CBA-1205 Part 1', 'type': 'DRUG', 'description': 'CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)', 'armGroupLabels': ['CBA-1205: Part 1']}, {'name': 'CBA-1205 Part 2', 'type': 'DRUG', 'description': 'CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)', 'armGroupLabels': ['CBA-1205: Part 2']}, {'name': 'CBA-1205 Part 3', 'type': 'DRUG', 'description': 'CBA-1205: 30 mg/kg (Intravenous solution)', 'armGroupLabels': ['CBA-1205: Part 3']}, {'name': 'CBA-1205 Part 4', 'type': 'DRUG', 'description': 'CBA-1205: 20 mg/kg (Intravenous solution)', 'armGroupLabels': ['CBA-1205 : Part 4']}, {'name': 'CBA-1205 Part 5', 'type': 'DRUG', 'description': 'CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)', 'armGroupLabels': ['CBA-1205: Part 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '277-8577', 'city': 'Kashiwa', 'state': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '241-8515', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kanagawa Cancer Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '951-8520', 'city': 'Niigata', 'state': 'Niigata', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Niigata University Medical and Dental Hospital', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '104-0045', 'city': 'Chūō', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 35.67004, 'lon': 139.77544}}, {'zip': '409-3898', 'city': 'Chūō', 'state': 'Yamanashi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'University of Yamanashi Hospital', 'geoPoint': {'lat': 35.59465, 'lon': 138.50275}}], 'centralContacts': [{'name': 'Tanaka Miseri Chiome Bioscience Inc.', 'role': 'CONTACT', 'email': 'ir@chiome.co.jp', 'phone': '+81-3-6383-3561'}, {'name': 'General Affairs and Human Resources Department Chiome Bioscience Inc.', 'role': 'CONTACT', 'phone': '+81-3-6383-3561'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiome Bioscience Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}