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

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).

Trial Details

NCT ID
NCT06419634
Phase
PHASE1
Sponsor
Bristol-Myers Squibb
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • BMS-986497
  • Azacitidine
  • Venetoclax
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • St Louis, Missouri, United States|38.62727,-90.19789

Key Eligibility Criteria

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

For full eligibility, visit ClinicalTrials.gov.

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