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RECRUITING
NCT06636435
PHASE1

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.

View on ClinicalTrials.gov

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

DRUG

CBA-1205 Part 1

CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)

DRUG

CBA-1205 Part 2

CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)

DRUG

CBA-1205 Part 3

CBA-1205: 30 mg/kg (Intravenous solution)

DRUG

CBA-1205 Part 4

CBA-1205: 20 mg/kg (Intravenous solution)

DRUG

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