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
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Connecticut
Yale-New Haven Hospital
RECRUITING
New Haven
Illinois
Local Institution - 0010
NOT_YET_RECRUITING
Chicago
Massachusetts
Local Institution - 0007
WITHDRAWN
Boston
Massachusetts General Hospital
RECRUITING
Boston
Missouri
Washington University School of Medicine, Siteman Cancer Center
RECRUITING
St Louis
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING
Hackensack
New York
Columbia University Irving Medical Center
WITHDRAWN
New York
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Virginia
Local Institution - 0009
WITHDRAWN
Fairfax
Other Locations
Canada
Jewish General Hospital
RECRUITING
Montreal
Princess Margaret Cancer Centre
RECRUITING
Toronto
France
Local Institution - 0017
NOT_YET_RECRUITING
Marseille
Local Institution - 0018
NOT_YET_RECRUITING
Paris
Local Institution - 0022
NOT_YET_RECRUITING
Toulouse
Spain
Local Institution - 0020
NOT_YET_RECRUITING
Barcelona
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2030-09-16
Participants
Target number of participants: 105
Treatments
Experimental: Part 1: Dose Escalation BMS-986497 (Monotherapy)
Experimental: Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)
Experimental: Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb