Study on the Safety and Effectiveness of BMS-986523 Alone and with Other Cancer Treatments for Advanced Solid Tumors

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT07223047

This clinical trial is testing a new drug, BMS-986523, to see if it is safe and effective when used alone or with other cancer treatments in people with advanced solid tumors.

Patient Parameters

Program Overview

The goal of this study is to determine if the new drug BMS-986523 is safe and can help treat advanced solid tumors. Researchers are testing the drug both by itself and in combination with other cancer treatments to see how well it works and how well patients tolerate it.

Eligibility 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.

Locations

FACILITYZIPCITYSTATE
Local Institution - 000921205BaltimoreMaryland
Local Institution - 000178229San AntonioTexas
Local Institution - 000784124Salt Lake CityUtah
Local Institution - 001122031FairfaxVirginia

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