Trial Title:
Study of BMS-986497 (ORM-6151) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
NCT ID:
NCT06419634
Condition:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Conditions: Keywords:
BMS-986497
First-in-Human
ORM-6151
Acute myeloid leukemia (AML)
Myelodysplastic syndrome (MDS)
Cluster of differentiation 33 (CD33)
G1 to S phase transition 1 (GSPT1)
Open label study
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BMS-986497
Description:
Specified dose on specified days
Arm group label:
Part 1: Dose Escalation BMS-986497
Arm group label:
Part 2: Dose Expansion BMS-986497
Summary:
The purpose of this study is to assess the safety, tolerability, drug levels, drug
efficacy and determine the recommended dose of BMS-986497 in participants with relapsed
or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale-New Haven Hospital
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amer Zeidan, Site 0011
Phone:
203-737-7078
Facility:
Name:
Local Institution - 0010
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Withdrawn
Facility:
Name:
Local Institution - 0007
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Withdrawn
Facility:
Name:
Local Institution - 0014
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0014
Facility:
Name:
Washington University School of Medicine, Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63108
Country:
United States
Status:
Recruiting
Contact:
Last name:
Geoffrey Uy, Site 0013
Phone:
314-273-1039
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jamie Koprivnikar, Site 0008
Phone:
551-996-3925
Facility:
Name:
Columbia University Irving Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Withdrawn
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Abhishek Maiti, Site 0006
Phone:
832-696-8407
Facility:
Name:
Local Institution - 0009
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Withdrawn
Facility:
Name:
Local Institution - 0002
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Site 0002
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Sarit Assouline, Site 0003
Phone:
5143408222x28434
Start date:
May 29, 2024
Completion date:
September 16, 2030
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06419634
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06419634.html
