BMS-986497 (ORM-6151)

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

What's the purpose of the trial?

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 status

Accepting patients

Phase

Phase 1

Enrollment

105

Last Updated

1 month ago

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Participating Centers

There are 6 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

Azacitidine is a type of chemotherapy called a hypomethylating agent that interferes with the growth and spread of cancer cells in the body.
BMS-986497 is a type of drug called a protein degrader that targets the GSPT1 and CD33 proteins found on some cancer cells.
Venetoclax is a BCL-2 inhibitor that may work by blocking the action of the BCL-2 protein on some cancer cells which can lead to cell death.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

Dose Escalation: BMS-986497 (Monotherapy)

Accepting patients

Dose Expansion: BMS-986497 (Combination Therapy)

Accepting patients

Dose Expansion: BMS-986497 (Triple Combination Therapy)

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