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Trial ID CA243-0001  |   NCT06997029

A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • 13
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Participants must be ≥ 18 years of age.
    1. Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.
      1. Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
        1. Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.
          1. For Part 2A only, participants must have CCNE1-amplified ovarian cancer

            Exclusion Criteria

            Exclusion Criteria Icon
            :
            • Participants must not have an active brain metastasis.
              1. Participants must not have impaired cardiac function or clinically significant cardiac disease.
                1. Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.
                  1. Participants must not have Grade ≥ 2 peripheral neuropathy.
                    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-986500

                      Study Arms

                      Experimental: Part 1B Combination Dose Escalation

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986500, Palbociclib, Fulvestrant

                      Study Arms

                      Experimental: Part 1C Monotherapy Pharmacodynamic (PD) Sub-study

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986500

                      Study Arms

                      Experimental: Part 2A Monotherapy Dose Expansion

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986500

                      Study Arms

                      Experimental: Part 2B Combination Dose Expansion

                      ASSIGNED INTERVENTION
                      • Drug: BMS-986500, Palbociclib, Fulvestrant
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