RECRUITINGPhase 1INTERVENTIONAL
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
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 Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 your organs (liver, kidneys, etc.) are working well enough based on blood tests.
Who Should NOT Join This Trial:
- Acute Promyelocytic Leukemia.
- Clinically active central nervous system leukemia.
- Active malignant solid tumor.
- Pregnant or breastfeeding.
- Other protocol-defined inclusion/exclusion criteria apply.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
BMS-986497
Specified dose on specified days
DRUG
Azacitidine
Specified dose on specified days
DRUG
Venetoclax
Specified dose on specified days
Locations (15)
Yale-New Haven Hospital
New Haven, Connecticut, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Local Institution - 0007
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine, Siteman Cancer Center
St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Irving Medical Center
New York, New York, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Local Institution - 0009
Fairfax, Virginia, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Local Institution - 0017
Marseille, Bouches-du-Rhône, France
Local Institution - 0018
Paris, France
Local Institution - 0022
Toulouse, France
Local Institution - 0020
Barcelona, Catalunya [Cataluña], Spain