NCT06636435

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

A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Chiome Bioscience Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To evaluate safety and efficacy of CBA-1205 in the following five parts in a stepwise manner: Part 1 * In Part 1, safety and tolerability in patients with Solid Tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated. Initial dose for Part 2 will be determined. Part 2 * In Part 2, safety and tolerability in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. Recommended dose in this population will be determined. Part 3 * In Part 3, safety and efficacy at the recommended dose in patients with advanced and/or recurrent Hepatocellular Carcinoma which are unresectable, or who are intolerable or non-responder to the standard treatment will be evaluated. Part 4 * In Part 4, safety and efficacy in patients with Malignant Melanoma who are refractory or intolerant to standard therapy. Part 5 * In Part 5, safety, tolerability and the recommended dose of the study drug in patients with Pediatric Cancer where no standard treatment is available, or who are intolerable or non-responder to the standard treatment will be evaluated. PK analysis

Conditions

• Solid Tumors
• Hepatocellular Carcinoma (HCC)
• Malignant Melanoma
• Pediatric Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-06-01
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-10-10
• Last updated: 2025-09-19

Locations

5 sites across 1 country: Japan