RecruitingRecruiting
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
NCT06419634 · Bristol-Myers Squibb
In plain English
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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
About this study
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 criteria
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 design
Enrollment target: 105 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-05-29
Estimated completion: 2030-09-16
Last updated: 2026-04-08
Interventions
Drug: BMS-986497Drug: AzacitidineDrug: Venetoclax
Primary outcomes
- • Incidence of dose-limiting toxicities (DLTs) (Up to 21 days)
- • Incidence of treatment-emergent adverse events (TEAEs) (Up to 2 years)
- • Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy (Up to 2 years)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (16)
Yale-New Haven HospitalRecruiting
New Haven, Connecticut, United States
Northwestern Memorial HospitalRecruiting
Chicago, Illinois, United States
Local Institution - 0007Withdrawn
Boston, Massachusetts, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Washington University School of Medicine, Siteman Cancer CenterRecruiting
St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Columbia University Irving Medical CenterWithdrawn
New York, New York, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Local Institution - 0009Withdrawn
Fairfax, Virginia, United States
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Local Institution - 0017Not Yet Recruiting
Marseille, Bouches-du-Rhône, France
Local Institution - 0018Not Yet Recruiting
Paris, France
Local Institution - 0022Not Yet Recruiting
Toulouse, France
Hospital Clínic de BarcelonaRecruiting
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Virgen Del RocioRecruiting
Seville, Spain