Actively Recruiting
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
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
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.
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
T
Tanaka Miseri Chiome Bioscience Inc.
CONTACT
G
General Affairs and Human Resources Department Chiome Bioscience Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here