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 1RecruitingNCT06419634

Bristol-Myers Squibb105 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Yale-New Haven Hospital

New Haven, Connecticut, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, United States

RECRUITING

Local Institution - 0007

Boston, Massachusetts, United States

WITHDRAWN

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Washington University School of Medicine, Siteman Cancer Center

St Louis, Missouri, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, United States

WITHDRAWN

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Local Institution - 0009

Fairfax, Virginia, United States

WITHDRAWN

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

RECRUITING

...and 6 more locations

Outcomes

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

The combination therapy included BMS-986497 and Azacitidine

Time frame: Up to 2 years

RP2D of BMS-986497 as Triple Combination Therapy

The triple combination therapy included BMS-986497, Azacitidine and Venetoclax.

Time frame: Up to 2 years

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

Central Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT