A Novel Glycoengineered Humanized Antibody Targeting DLK1 Exhibits Potent Anti-Tumor Activity in DLK1-Expressing Liver Cancer Cell Xenograft Models.
Koji Nakamura, Kota Takahashi, Izumi Sakaguchi...
https://pubmed.ncbi.nlm.nih.gov/39769389Actively Recruiting
Phase 1
Age: 2Years +
All Genders
ID06636435
Phase I First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody, in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma, Melanoma, and Pediatric Cancer
Led by Chiome Bioscience Inc. · Updated on 2025-09-19
66
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and efficacy of CBA-1205, an anti-DLK1 monoclonal antibody, in patients with advanced solid tumors including hepatocellular carcinoma, malignant melanoma, and certain pediatric cancers. This first-in-human, Phase I, multi-center, non-randomized, open-label study is designed in five parts to assess these outcomes in different patient groups, especially those who have no standard treatment options or are intolerant or non-responsive to existing therapies. The study treatment involves intravenous administration of CBA-1205 at varying doses depending on the study part. In Part 1, doses from 0.1 to 30 mg/kg are given every two weeks in 28-day cycles to patients with solid tumors. Parts 2 through 5 administer doses ranging from 10 to 30 mg/kg every two weeks in similar 28-day cycles to patients with hepatocellular carcinoma, malignant melanoma, and pediatric cancers, continuing until criteria for treatment discontinuation are met. Participants will undergo safety and tolerability evaluations, including monitoring for dose-limiting toxicity during the first 28 days and adverse events up to 12 months. Pharmacokinetic and immunogenicity analyses will be conducted from Day 1 to Day 43 or until treatment discontinuation. Efficacy will be assessed at screening and regular intervals during treatment. The study includes detailed laboratory tests and performance status assessments, with the total participation duration varying by individual response and treatment continuation.
CONDITIONS
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
Who Can Participate
Age: 2Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients who provide voluntary written informed consent to participate in the study
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less (Parts 1-4)
- Patients with preserved renal function based on recent laboratory tests
- Patients with adequate bone marrow function as shown by neutrophil count, platelet count, and hemoglobin levels
- Patients having solid tumors with no standard therapy available or refractory or intolerant to standard therapy (Parts 2, 3)
- Patients with Child-Pugh A or B liver function (Parts 2, 3)
- Patients with malignant melanoma who are refractory or intolerant to standard therapy (Part 4)
- Patients who provide voluntary written informed consent from both the subject (if aged 16 years or older) and their legal representatives (Part 5)
- Japanese patients aged 2 years or older and under 20 years at the time of consent (Part 5)
- Patients with Lansky Performance Status of 70 or greater (for patients 15 years or younger) or Karnofsky Performance Status of 70 or greater (for patients 16 years or older) (Part 5)
- Pediatric patients with preserved renal function (eGFR ≥ 60 mL/min/1.73 m²) (Part 5)
- Pediatric patients with cancers with no standard therapy available or refractory or intolerant to standard therapy (Part 5)
You will not qualify if you...
- Patients who have undergone major surgery within 28 days before enrollment
- Patients who have received anticancer treatment with surgery, radiation, or drug therapy within 14 days before enrollment
- Patients who have received immune checkpoint inhibitor treatment 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 prior inadequately controlled or clinically significant cardiac disease
- Patients deemed inappropriate for the study by the investigator or subinvestigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 months or until treatment discontinuation
Participants receive the study drug CBA-1205 intravenously at 2-week intervals in 28-day cycles. Treatment continues until criteria for discontinuation are met. Different parts of the study involve different doses and patient populations with advanced solid tumors, hepatocellular carcinoma, malignant melanoma, or pediatric cancer.
Bi-weekly visits for study drug administration and assessments
Follow-up
Duration - Up to 12 months
Participants are monitored for adverse events and safety outcomes for up to 12 months after treatment initiation.
Visits according to study schedule for safety monitoring
Trial Site Locations
Total: 5 locations
1
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
2
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
Actively Recruiting
3
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
4
National Cancer Center Hospital
Chūō, Tokyo, Japan, 104-0045
Actively Recruiting
5
University of Yamanashi Hospital
Chūō, Yamanashi, Japan, 409-3898
Actively Recruiting
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Research Team
T
Tanaka Miseri Chiome Bioscience Inc.
G
General Affairs and Human Resources Department Chiome Bioscience Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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Published Research Related To This Trial
A Phase I, First-In-Human Study of CBA-1205, an Anti-DLK1 Monoclonal Antibody, in Patients With Advanced Solid Tumors.
Yuki Katsuya, Masafumi Ikeda, Takafumi Koyama...
https://pubmed.ncbi.nlm.nih.gov/39832211