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Trial ID CA254-0001  |   NCT07160725

A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors

Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 18
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participants must have an ECOG performance status of 0 to 1.
    1. Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator).
      1. Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2
        1. breast cancer.

          Exclusion Criteria

          Exclusion Criteria Icon
          • Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
            1. Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
              1. Participants must not have history of serious recurrent infections.
                1. Participants must not have impaired cardiac function or history of severe heart disease.
                  1. For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy.
                    1. For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis.
                      1. For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding.
                        Additional Information *
                        • Other protocol-defined Inclusion/Exclusion criteria apply.

                          Treatment Options

                          Study Arms

                          ASSIGNED INTERVENTION

                          Study Arms

                          Experimental: Part 1A Monotherapy Dose Escalation

                          ASSIGNED INTERVENTION
                          • Drug: BMS-986517

                          Study Arms

                          Experimental: Part 1B Combination Dose Escalation

                          ASSIGNED INTERVENTION
                          • Drug: BMS-986517, Pumitamig

                          Study Arms

                          Experimental: Part 1C: Monotherapy PD Sub-study

                          ASSIGNED INTERVENTION
                          • Drug: BMS-986517

                          Study Arms

                          Experimental: Part 2A: Monotherapy Dose Expansion Cohort A

                          ASSIGNED INTERVENTION
                          • Drug: BMS-986517

                          Study Arms

                          Experimental: Part 2A: Monotherapy Dose Expansion Cohort B

                          ASSIGNED INTERVENTION
                          • Drug: BMS-986517

                          Study Arms

                          Experimental: Part 2A: Monotherapy Dose Expansion Cohort C

                          ASSIGNED INTERVENTION
                          • Drug: BMS-986517

                          Study Arms

                          Experimental: Part 2B: Combination Dose Expansion Cohort A

                          ASSIGNED INTERVENTION
                          • Drug: Pumitamig, BMS-986517

                          Study Arms

                          Experimental: Part 2B: Combination Dose Expansion Cohort B

                          ASSIGNED INTERVENTION
                          • Drug: Pumitamig, BMS-986517
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