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

June 15, 2026 updated by: Chiome Bioscience Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tanaka Miseri Chiome Bioscience Inc.
  • Phone Number: +81-3-6383-3561
  • Email: ir@chiome.co.jp

Study Contact Backup

  • Name: General Affairs and Human Resources Department Chiome Bioscience Inc.
  • Phone Number: +81-3-6383-3561

Study Locations

  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center
    • Niigata
      • Niigata, Niigata, Japan, 951-8520
        • Recruiting
        • Niigata University Medical and Dental Hospital
    • Tokyo
      • Chūō, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
    • Yamanashi
      • Chūō, Yamanashi, Japan, 409-3898
        • Recruiting
        • University of Yamanashi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:(Part 1-4)

  • Patients who provide voluntary written informed consent to participate in the study
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1
  • Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)
  • Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: Neutrophil count;≥1500/μL, Platelet count; ≥75000/μL, Hemoglobin;≥9.0 g/dL.
  • Patients having Solid Tumors with no standard therapy available or refractory or intolerable to standard therapy (Part2, 3)
  • Patients with Child-Pugh A or B (Part2, 3)
  • Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4)

Inclusion Criteria:(Part 5)

  • Patients who provide voluntary written informed consent to participate in the study from both the subject (if aged 16 years or older) and their legal representatives
  • Japanese patients aged 2 years or older and under 20 years at the time of informed consent
  • Patients with a Lansky Performance Status (LPS) of ≥70 (for patients aged 15 years or younger) or a Karnofsky Performance Status (KPS) of ≥70 (for patients aged 16 years or older)
  • Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (eGFR ≥60 mL/min/1.73 m²)
  • Pediatric patients with cancers with no standard therapy available or refractory or intolerable to the standard therapy

Exclusion criteria: (Part1-5)

  • Patients who have undergone major surgery within 28 days before enrollment
  • Patients who have received anticancer treatment with surgical therapy, radiation therapy, and/or drug therapy within 14 days before enrollment
  • Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment
  • Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity
  • Patients who have received any other investigational product within 28 days before enrollment
  • Patients with current or previous inadequately controlled or clinically significant cardiac disease
  • Patients who, in the opinion of the investigator or subinvestigator, is not appropriate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBA-1205: Part 1

CBA-1205 injection is administered at 2-week intervals in seven cohorts (0.1, 0.3, 1, 3, 10, 20, 30 mg/kg) in patients with solid tumor.

Note: In the study treatment period, CBA-1205 is intravenously administered at 2-week intervals in a 28-day cycle.
Drug: CBA-1205 Part 1
CBA-1205: 0.1, 0.3, 1, 3, 10, 20, 30 mg/kg (Intravenous solution)
Experimental: CBA-1205: Part 2

CBA-1205 (20, 30 mg/kg) injection is administered at 2-week intervals in 28-day cycles in patients with HCC .

Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.
Drug: CBA-1205 Part 2
CBA-1205: 20 mg/kg and 30 mg/kg (Intravenous solution)
Experimental: CBA-1205: Part 3

CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with HCC.

Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.
Drug: CBA-1205 Part 3
CBA-1205: 30 mg/kg (Intravenous solution)
Experimental: CBA-1205 : Part 4

CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Malignant Melanoma.

Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.
Drug: CBA-1205 Part 4
CBA-1205: 20 mg/kg (Intravenous solution)
Experimental: CBA-1205: Part 5

CBA-1205 injection is administered at 2-week intervals in 28-day cycles in patients with Pediatric Cancer.

Note: The study drug is administered at 2-week intervals until any of the criteria for discontinuation of study treatment are met.
Drug: CBA-1205 Part 5
CBA-1205: 10 mg/kg (The initial cohort, Intravenous solution)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicity
Time Frame: Part 1, 2 and 5 - Dose limiting toxicity : For 28 days after the first dose of study treatment
DLTs are assessed according to CTCAE v.5.0 during the first cycle (28 days).
Part 1, 2 and 5 - Dose limiting toxicity : For 28 days after the first dose of study treatment
Adverse Event
Time Frame: Adverse event : Maximum 12 months
An adverse event is any untoward or unintended sign, symptom, or disease in a subject administered an investigational product, whether or not it is related to the investigational product
Adverse event : Maximum 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum CBA-1205 concentration
Time Frame: From Day 1 to Day 43 (or until Discontiuation of treatment)
Blood samples are collected to assess the serum concentration of CBA-1205.
From Day 1 to Day 43 (or until Discontiuation of treatment)
Immunogenicity
Time Frame: From Day1 to Day 43 (or until Discontiuation of treatment)
Blood samples are collected to assess the serum anti-CBA-1205 antibody.
From Day1 to Day 43 (or until Discontiuation of treatment)
Efficacy
Time Frame: Screening, Day 1 of Cycle 2 and 3, and Day 1 of even-numbered cycles from Cycle 4 onward until treatment discontinuation. Maximum 12 months

Antitumor response evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Tumor markers
Screening, Day 1 of Cycle 2 and 3, and Day 1 of even-numbered cycles from Cycle 4 onward until treatment discontinuation. Maximum 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploration of biomarkers:
Time Frame: Baseline through disease progression assessed (Maximum 12 months.)

Exploration of biomarkers:

Delta-like 1 homolog (DLK1)-related marker
Baseline through disease progression assessed (Maximum 12 months.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiome Bioscience Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1205-001
  • jRCT2080225288 (Other Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the strict regulations and confidentiality concerns surrounding patient data in Japan, we will not be able to share the Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), and Clinical Study Report (CSR). Ensuring patient privacy and compliance with local regulatory requirements is our top priority.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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