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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

RECRUITINGPhase 1Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 1
SponsorBristol-Myers Squibb
Started2024-05-29
Est. completion2027-02-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations9 sites
View on ClinicalTrials.gov →

NCT06419634

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).

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions3

Acute Myeloid LeukemiaCancerMyelodysplastic Syndrome

Locations9 sites

Yale-New Haven Hospital
New Haven, Connecticut, 06510
Amer Zeidan, Site 0011203-737-7078
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Jessica Altman, Site 0010312-503-1794
Local Institution - 0007
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02114
Rupa Narayan, Site 0014617-724-3456
Washington University School of Medicine, Siteman Cancer Center
St Louis, Missouri, 63108
Geoffrey Uy, Site 0013314-273-1039

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