A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

Last updated: May 13, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Adagrasib

Cetuximab

Nivolumab

Clinical Study ID

NCT06764771
CA234-0001
  • Ages > 18
  • All Genders

Study Summary

This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be ≥ 18 years of age.

  • Histologically confirmed diagnosis of a locally advanced and unresectable ormetastatic solid tumor malignancy with any of the following tumor types:.

  • Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC),non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductaladenocarcinoma (PDAC).

  • Parts 2A, 1D, 2D: ccRCC. i) Part 1B: solid tumors with KRAS G12C mutation.

ii) Part 2B: NSCLC with KRAS G12C mutation.

iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.

  • Participants must have an Eastern Cooperative Oncology Groups (ECOG) PerformanceStatus of 0 or 1.

  • Participants must have measurable disease per RECIST v1.1.

Exclusion

Exclusion Criteria:

  • Untreated central nervous system (CNS) metastases.

  • Leptomeningeal metastasis (carcinomatous meningitis).

  • Impaired cardiac function or clinically significant cardiac disease.

  • For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):. i) History of pneumonitis or interstitial lung disease (ILD).

ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

  • Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 437
Treatment Group(s): 4
Primary Treatment: Adagrasib
Phase: 1
Study Start date:
March 25, 2025
Estimated Completion Date:
October 15, 2027

Connect with a study center

  • Local Institution - 0031

    Brisbane, Queensland 4029
    Australia

    Site Not Available

  • BC Cancer Vancouver

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • Local Institution - 0032

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Local Institution - 0015

    Montréal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Local Institution - 0016

    Quebec City, Quebec G1J 1Z4
    Canada

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Local Institution - 0021

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Local Institution - 0020

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Local Institution - 0024

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • The West Clinic, PLLC dba West Cancer Center

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Local Institution - 0025

    Dallas, Texas 75390
    United States

    Site Not Available

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