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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Myelodysplastic Syndrome; Acute Myeloid Leukemia

Treatments: Drug: Azacitidine; Drug: Venetoclax; Drug: BMS-986497

Study type: Interventional

Funder types: Industry

Identifiers

NCT06419634

CA235-0001

2024-519537-29 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Part 1: Dose Escalation BMS-986497 (Monotherapy)

Experimental group

Treatment:

Drug: BMS-986497

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

Experimental group

Treatment:

Drug: BMS-986497

Drug: Azacitidine

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

Experimental group

Treatment:

Drug: BMS-986497

Drug: Venetoclax

Drug: Azacitidine