Study of BMS-986497 (ORM-6151) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome
• Interventions: Drug: BMS-986497

• Registration Number: NCT06419634
• Lead Sponsor: Bristol-Myers Squibb

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-17
• Study Start: 2024-05-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-14
• Primary Completion: 2027-02-01
• Study Completion: 2030-09-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 2: Dose Expansion BMS-986497	BMS-986497	-
Part 1: Dose Escalation BMS-986497	BMS-986497	-

Primary Outcome Measures

Name	Time	Method
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)	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Best overall response (BOR)	Up to 4 years
Complete remission (CR)	Up to 4 years
Event-free survival (EFS)	Up to 4 years
Time to reach Cmax (Tmax)	Up to 2 years
Area under the curve from time 0 to last quantifiable concentration (AUC0-last)	Up to 2 years
Complete remission with incomplete hematologic recovery (Cri)	Up to 4 years
Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT)	Up to 4 years
Maximum concentration (Cmax)	Up to 2 years
Overall response rate (ORR)	Up to 4 years
Duration of response (DoR)	Up to 4 years
Complete remission with partial hematologic recovery (CRh) rate	Up to 4 years
Incidence of Anti-drug antibody (ADA) against BMS-986497	Up to 2 years

Trial Locations

Locations (11)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Local Institution - 0010; 🇺🇸 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; 🇺🇸 Saint Louis, Missouri, United States

Oncology Clinical Research Referral Office; 🇺🇸 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

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada