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Trial ID CA256-0001  |   NCT07223047

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

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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 8
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • 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).
    1. Participants must, for Arm D, have a PD-L1 expression (≥50%).
      1. 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

        Exclusion Criteria Icon
        • Participants must not have untreated central nervous system (CNS) metastases.
          1. Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
            1. 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.
              1. Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
                Additional Information *
                • Other protocol-defined Inclusion/Exclusion criteria apply.

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Arm A

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986523

                  Study Arms

                  Experimental: Arm B

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986523

                  Study Arms

                  Experimental: Arm C

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986523

                  Study Arms

                  Experimental: Arm D

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986523, Pembrolizumab

                  Study Arms

                  Experimental: Arm E

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986523, Cetuximab

                  Study Arms

                  Experimental: Arm F

                  ASSIGNED INTERVENTION
                  • Drug: BMS-986523, Gemcitabine, Nab-Paclitaxel
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