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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: Chiome Bioscience Inc.
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.
Official title: A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2020-06-01
Completion Date
2026-06-30
Last Updated
2025-09-19
Healthy Volunteers
No
Interventions
CBA-1205 Part 1
CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)
CBA-1205 Part 2
CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)
CBA-1205 Part 3
CBA-1205: 30 mg/kg (Intravenous solution)
CBA-1205 Part 4
CBA-1205: 20 mg/kg (Intravenous solution)
CBA-1205 Part 5
CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)
Locations (5)
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
National Cancer Center Hospital
Chūō, Tokyo, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, Japan