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Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome


Description

The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Trial Eligibility

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.

Study Info

Organization

Bristol-Myers Squibb


Primary Outcome

Incidence of dose-limiting toxicities (DLTs)


Outcome Timeframe Up to 21 days

NCTID NCT06419634

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2024-05-29

Completion Date 2027-02-01

Enrollment Target 35

Interventions

DRUG BMS-986497

Locations Recruiting

Yale-New Haven Hospital

United States, Connecticut, New Haven


Local Institution - 0010

United States, Illinois, Chicago


Local Institution - 0007

United States, Massachusetts, Boston


Massachusetts General Hospital

United States, Massachusetts, Boston


Washington University School of Medicine, Siteman Cancer Center

United States, Missouri, Saint Louis


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