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
2 other identifiers
interventional
66
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2020
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
September 19, 2025
September 1, 2025
6.1 years
September 30, 2024
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose limiting toxicity
DLTs are assessed according to CTCAE v.5.0 during the first cycle (28 days).
Part 1, 2 and 5 - Dose limiting toxicity : For 28 days after the first dose of study treatment
Adverse Event
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
Adverse event : Maximum 12 months
Secondary Outcomes (3)
Serum CBA-1205 concentration
From Day 1 to Day 43 (or until Discontiuation of treatment)
Immunogenicity
From Day1 to Day 43 (or until Discontiuation of treatment)
Efficacy
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
Other Outcomes (1)
Exploration of biomarkers:
Baseline through disease progression assessed (Maximum 12 months.)
Study Arms (5)
CBA-1205: Part 1
EXPERIMENTALCBA-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. Note: In the study treatment period, CBA-1205 is intravenously administered at 2-week intervals in a 28-day cycle.
CBA-1205: Part 2
EXPERIMENTALCBA-1205 (20, 30 mg/kg) injection is administered at 2-week intervals in 28-day cycles in patients with HCC . Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.
CBA-1205: Part 3
EXPERIMENTALCBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with HCC. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.
CBA-1205 : Part 4
EXPERIMENTALCBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Malignant Melanoma. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.
CBA-1205: Part 5
EXPERIMENTALCBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Pediatric Cancer. Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.
Interventions
CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)
Eligibility Criteria
You may qualify if:
- Patients who provide voluntary written informed consent to participate in the study
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1
- Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)
- 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.
- Patients having Solid Tumors with no standard therapy available or refractory or intolerable to standard therapy (Part2, 3)
- Patients with Child-Pugh A or B (Part2, 3)
- Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4)
- 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
- Japanese patients aged 2 years or older and under 20 years at the time of informed consent
- 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)
- Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (eGFR ≥60 mL/min/1.73 m²)
- Pediatric patients with cancers with no standard therapy available or refractory or intolerable to the standard therapy
You may not qualify if:
- Patients who have undergone major surgery within 28 days before enrollment
- Patients who have received anticancer treatment with surgical therapy, radiation therapy, and/or drug therapy within 14 days before enrollment
- Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment
- Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity
- Patients who have received any other investigational product within 28 days before enrollment
- Patients with current or previous inadequately controlled or clinically significant cardiac disease
- Patients who, in the opinion of the investigator or subinvestigator, is not appropriate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520, Japan
National Cancer Center Hospital
Chūō, Tokyo, 104-0045, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898, Japan
Related Publications (2)
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: 39769389BACKGROUNDKatsuya 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.
PMID: 39832211BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2024
First Posted
October 10, 2024
Study Start
June 1, 2020
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share