A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

Study Identifier:
CA2560001
CT.gov Identifier:
NCT07223047
EudraCT Identifier:
2025-523547-35
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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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

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Unspecified Cancer
  • Non-Small Cell Lung Cancer
  • Bowel (Colorectal)
  • Pancreas
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Arm A
    • Read More
  • Drug: Drug: BMS-986523
  • Drug: Specified dose on specified days
  • Drug: EXPERIMENTAL: Arm B
  • Drug: EXPERIMENTAL: Arm C
  • Drug: EXPERIMENTAL: Arm D
  • Drug: Drug: Pembrolizumab
  • Drug: EXPERIMENTAL: Arm E
  • Drug: Drug: Cetuximab
  • Drug: EXPERIMENTAL: Arm F
  • Drug: Drug: Gemcitabine
  • Drug: Drug: Nab-Paclitaxel
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Justin Call
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Pancreas