drugset
drugset / Trial / 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

NCT06419634 ↗

Phase 1 Recruiting 105 enrolled Bristol-Myers Squibb
Non-randomizedSequentialOpen-labelTreatment

Summary

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).

Timeline

Start
2024-05-29
Primary completion
2027-02-01
Completion
2030-09-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified — —
Subject BMS-986497 Unknown — —
Subject Venetoclax Small molecule — —

Indications

acute myeloid leukemia myelodysplastic syndrome