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Trial ID CA235-0001  |   NCT06419634

Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • 12
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 as a monotherapy, in double combination with Azacitidine and in triple combination with Azacitidine and Venetoclax in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
    1. Detectable levels of cluster of differentiation 33 (CD33) expression.
      1. Failed alternative therapies with established benefit.
        1. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • Acute Promyelocytic Leukemia.
            1. Clinically active central nervous system leukemia.
              1. Active malignant solid tumor.
                1. Pregnant or breastfeeding.
                  1. Other protocol-defined inclusion/exclusion criteria apply.
                    Additional Information *

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Part 1: Dose Escalation BMS-986497 (Monotherapy)

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986497

                    Study Arms

                    Experimental: Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)

                    ASSIGNED INTERVENTION
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