A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients with Advanced Solid Tumors and Hepatocellular Carcinoma (HCC)

Last updated: October 9, 2024
Sponsor: Chiome Bioscience Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Carcinoma

Solid Tumors

Treatment

CBA-1205

Clinical Study ID

NCT06636435
1205-001
jRCT2080225288
  • Ages > 20
  • All Genders

Study Summary

In this first-in-human, multicenter,non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 3parts(Part1-3). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 obtainedwithin 7 days before enrollment (creatinine: ≤ ULN ×1.5)

  • Patients who meet the following laboratory criteria of bone marrow function asevidenced 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 orintolerable to standard therapy

  • Patients with unresectable advanced/recurrent hepatocellular carcinoma refractory orintolerable to standard therapy (Part2, 3: HCC)

  • Patients with Child-Pugh A or B (Part2, 3; HCC)

Exclusion

Exclusion criteria:

  • Patients who have undergone major surgery within 28 days before enrollment

  • Patients who have received anticancer treatment with surgical therapy, radiationtherapy, 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 beforeenrollment

  • Patients with current or previous inadequately controlled or clinically significantcardiac disease

  • Patients who, in the opinion of the investigator or subinvestigator, is notappropriate

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: CBA-1205
Phase: 1
Study Start date:
June 01, 2020
Estimated Completion Date:
June 30, 2025

Study Description

To evaluate safety and efficacy of CBA-1205 in the following three parts in a stepwise manner:

  • 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.

  • 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.

  • 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.

  • PK analysis

Connect with a study center

  • National Cancer Center Hospital East

    Kashiwa, Chiba
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center

    Yokohama, Kanagawa
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo, Tokyo
    Japan

    Active - Recruiting

  • Niigata University Medical and Dental Hospital

    Niigata,
    Japan

    Active - Recruiting

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