BMS-986497
DrugSpecified dose on specified days
Other names: ORM-6151
Recruiting
NCT Number: NCT06419634
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
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Azacitidine
DrugSpecified dose on specified days
Venetoclax
DrugSpecified dose on specified days
Primary outcomes
-
Incidence of dose-limiting toxicities (DLTs)
Time frame: Up to 21 days
-
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years
-
Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy
Time frame: Up to 2 years
-
RP2D of BMS-986497 as Combination Therapy
Time frame: Up to 2 years
The combination therapy included BMS-986497 and Azacitidine
-
RP2D of BMS-986497 as Triple Combination Therapy
Time frame: Up to 2 years
The triple combination therapy included BMS-986497, Azacitidine and Venetoclax.
Secondary outcomes
-
Maximum concentration (Cmax)
Time frame: Up to 2 years
-
Time to reach Cmax (Tmax)
Time frame: Up to 2 years
-
Area under the curve from time 0 to last quantifiable concentration (AUC0-last)
Time frame: Up to 2 years
-
Overall response rate (ORR)
Time frame: Up to 4 years
-
Duration of response (DoR)
Time frame: Up to 4 years
-
Best overall response (BOR)
Time frame: Up to 4 years
-
Complete remission (CR)
Time frame: Up to 4 years
-
Complete remission with incomplete hematologic recovery (Cri)
Time frame: Up to 4 years
-
Complete remission with partial hematologic recovery (CRh) rate
Time frame: Up to 4 years
-
Event-free survival (EFS)
Time frame: Up to 4 years
-
Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT)
Time frame: Up to 4 years
-
Incidence of Anti-drug antibody (ADA) against BMS-986497
Time frame: Up to 2 years
Study contacts
Contact information is provided by the study sponsor or research team.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2030
- First posted
- May 17, 2024
- Registry last updated
- Apr 8, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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