Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

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