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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

NCT06636435 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

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

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)

Sponsors & Collaborators

  • Chiome Bioscience Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06636435 on ClinicalTrials.gov