A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

Last updated: May 26, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1/2

Condition

Digestive System Neoplasms

Treatment

Cetuximab

Gemcitabine

Nab-Paclitaxel

Clinical Study ID

NCT07223047
CA256-0001
2025-523547-35
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification).

  • Participants must, for Arm D, have a PD-L1 expression (≥50%).

  • Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments.

Exclusion Criteria

  • Participants must not have untreated central nervous system (CNS) 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 a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted.

  • Participants must not have a 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: 252
Treatment Group(s): 5
Primary Treatment: Cetuximab
Phase: 1/2
Study Start date:
November 25, 2025
Estimated Completion Date:
October 13, 2028

Connect with a study center

  • BC Cancer Vancouver

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • Local Institution - 0002

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Local Institution - 0002

    Vancouver 6173331, British Columbia 5909050 V5Z 4E6
    Canada

    Site Not Available

  • Local Institution - 0010

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Local Institution - 0010

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • Local Institution - 0006

    Badalona, Barcelona [Barcelona] 08916
    Spain

    Site Not Available

  • Local Institution - 0006

    Badalona 3129028, Barcelona [Barcelona] 08916
    Spain

    Site Not Available

  • Local Institution - 0008

    Hortaleza, Madrid 28050
    Spain

    Site Not Available

  • Local Institution - 0008

    Hortaleza 3120635, Madrid 3117732 28050
    Spain

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Local Institution - 0009

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Local Institution - 0009

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Local Institution - 0001

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • START Mountain Region

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • Local Institution - 0007

    Salt Lake City 5780993, Utah 5549030 84124
    United States

    Site Not Available

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Local Institution - 0011

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

  • NEXT Virginia

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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