RecruitingPhase 1NCT06636435

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.


Sponsor

Chiome Bioscience Inc.

Enrollment

66 participants

Start Date

Jun 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing CBA-1205, a new antibody drug that targets a protein called DLK1 found on certain cancer cells. It is being tested in adults with advanced solid tumors (including liver cancer and melanoma) and in children with cancer who have no remaining standard treatment options. **You may be eligible if...** - You are an adult with advanced solid tumors, liver cancer (hepatocellular carcinoma), or melanoma that has not responded to standard treatments - You are a Japanese child (ages 2–19) with cancer that has not responded to standard treatments - You are in relatively good physical condition (able to perform basic daily activities) - Your blood counts and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have had major surgery, chemotherapy, or radiation within the past 2–4 weeks - You have uncontrolled side effects from prior cancer treatment (Grade 2 or higher) - You are pregnant or breastfeeding - You have active infections or other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCBA-1205 Part 1

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

DRUGCBA-1205 Part 2

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

DRUGCBA-1205 Part 3

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

DRUGCBA-1205 Part 4

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

DRUGCBA-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

View Full Details on ClinicalTrials.gov

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NCT06636435


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