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Status:

RECRUITING

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Advanced Solid Malignancies

Non-small Cell Lung Cancer (NSCLC)

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief 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.

Exclusion

    Key Trial Info

    Start Date :

    November 25 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 13 2028

    Estimated Enrollment :

    252 Patients enrolled

    Trial Details

    Trial ID

    NCT07223047

    Start Date

    November 25 2025

    End Date

    October 13 2028

    Last Update

    December 17 2025

    Active Locations (8)

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    Page 1 of 2 (8 locations)

    1

    Local Institution - 0009

    Baltimore, Maryland, United States, 21205

    2

    NEXT Oncology

    San Antonio, Texas, United States, 78229

    3

    Local Institution - 0007

    Salt Lake City, Utah, United States, 84124

    4

    Local Institution - 0011

    Fairfax, Virginia, United States, 22031