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
A Phase I Study of CBA-1205, an 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
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and tolerability of CBA-1205, an anti-DLK1 monoclonal antibody, in patients with various advanced cancers including solid tumors, hepatocellular carcinoma (HCC), malignant melanoma, and pediatric cancers. It is a first-in-human, multicenter, open-label Phase I study conducted in five parts, focusing on patients who have no standard treatment options or who have not responded or are intolerant to standard therapies. The study also includes pharmacokinetic (PK) analysis to understand how the drug behaves in the body. The study is divided into five parts with different patient groups and dosing schedules. Parts 1 through 4 focus on adults with solid tumors, advanced or recurrent HCC, and malignant melanoma, testing escalating doses of CBA-1205 given intravenously ranging from 0.1 to 30 mg/kg. Part 5 focuses on pediatric cancer patients aged 2 to under 20 years, starting with a 10 mg/kg dose. Each part evaluates safety, tolerability, and determines recommended doses, with some parts also assessing efficacy. Participants will be closely monitored for dose-limiting toxicities during the first 28 days after the initial dose and for adverse events for up to 12 months. Assessments include physical exams, laboratory tests to check organ function and blood counts, and performance status evaluations. Safety will be continuously reviewed throughout the study. The total duration of participation varies by study part, with detailed follow-up to ensure participant well-being and collect data on treatment effects.
CONDITIONS
Official 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
- Patients with preserved kidney function as shown by lab tests within 7 days before enrollment (creatinine ≤ 1.5 times the upper limit of normal)
- Patients with adequate bone marrow function shown by lab tests within 7 days before enrollment: neutrophils ≥ 1500/µL, platelets ≥ 75000/µL, hemoglobin ≥ 9.0 g/dL
- Patients with solid tumors that have no standard therapy available or are refractory or intolerant to standard therapy (Parts 2 and 3)
- Patients with Child-Pugh class A or B liver function (Parts 2 and 3)
- Patients with malignant melanoma who are refractory or intolerant to standard therapy (Part 4)
- Patients aged 2 years or older and under 20 years at consent (Part 5, Japanese patients)
- Patients with Lansky Performance Status of 70 or higher if 15 years or younger, or Karnofsky Performance Status of 70 or higher if 16 years or older (Part 5)
- Pediatric patients with preserved kidney function as shown by lab tests within 7 days before enrollment (eGFR ≥ 60 mL/min/1.73 m², Part 5)
- Pediatric patients with cancers that have no standard therapy available or are refractory or intolerant to standard therapy (Part 5)
You will not qualify if you...
- Patients who have had major surgery within 28 days before enrollment
- Patients who have received anticancer treatment such as surgery, radiation, or drug therapy within 14 days before enrollment
- Patients who have received immune checkpoint inhibitors or similar anticancer treatments within 28 days before enrollment
- Patients with grade 2 or higher concurrent diseases or treatment-related toxicity
- Patients who have received any other investigational drug within 28 days before enrollment
- Patients with current or prior uncontrolled or significant heart disease
- Patients deemed inappropriate for the study by the investigator or subinvestigator
AI-Screening
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1
2
3
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