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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
Sponsor: Bristol-Myers Squibb
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2024-05-29
Completion Date
2026-08-28
Last Updated
2026-10-01
Healthy Volunteers
No
Interventions
BMS-986497
Specified dose on specified days
Azacitidine
Specified dose on specified days
Venetoclax
Specified dose on specified days
Locations (10)
Local Institution - 0011
New Haven, Connecticut, United States
Local Institution - 0010
Chicago, Illinois, United States
Local Institution - 0014
Boston, Massachusetts, United States
Local Institution - 0013
St Louis, Missouri, United States
Local Institution - 0008
Hackensack, New Jersey, United States
Local Institution - 0006
Houston, Texas, United States
Local Institution - 0002
Toronto, Ontario, Canada
Local Institution - 0003
Montreal, Quebec, Canada
Local Institution - 0020
Barcelona, Catalunya [Cataluña], Spain
Local Institution - 0023
Seville, Spain