A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.

Last updated: July 29, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

Carcinoma

Treatment

BMS-986463

Clinical Study ID

NCT06476808
CA231-0000
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

  • Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained.

  • Participants must have an unresectable/metastatic carcinoma.

Exclusion Criteria

  • Participants must not have Leptomeningeal metastases.

  • Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.

  • Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: BMS-986463
Phase: 1
Study Start date:
September 06, 2024
Estimated Completion Date:
December 19, 2028

Connect with a study center

  • Local Institution - 0025

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • BC Cancer Vancouver

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • Local Institution - 0026

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Local Institution - 0027

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Local Institution - 0024

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Local Institution - 0028

    Montréal, Quebec H2X 3E4
    Canada

    Site Not Available

  • Local Institution - 0003

    Los Angeles, California 90033
    United States

    Site Not Available

  • Local Institution - 0006

    Los Angeles, California 90067
    United States

    Site Not Available

  • Local Institution - 0014

    Los Angeles, California 90033
    United States

    Site Not Available

  • Local Institution - 0017

    Los Angeles, California 90067
    United States

    Site Not Available

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • Local Institution - 0015

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Local Institution - 0020

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale-New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Local Institution - 0018

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Local Institution - 0023

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Local Institution - 0021

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution - 0016

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution - 0022

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution - 0019

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Local Institution - 0001

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Local Institution - 0013

    Hackensack, New Jersey 07601
    United States

    Site Not Available

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