RecruitingPhase 1NCT06419634

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 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

Sponsor

Bristol-Myers Squibb

Enrollment

105 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndrome

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BMS-986497 (also known as ORM-6151) — alone or combined with existing cancer medications — for people with relapsed or treatment-resistant acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), which are serious blood cancers. **You may be eligible if...** - You are an adult with AML or MDS that has come back or stopped responding to treatment - Your cancer cells test positive for a protein called CD33 - You have already tried other available treatments - You are in reasonably good physical health (able to carry out light activities) **You may NOT be eligible if...** - You have a specific type of leukemia called Acute Promyelocytic Leukemia (APL) - You have leukemia that has spread to the brain or spinal fluid - You have another active solid tumor cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986497

Specified dose on specified days

DRUGAzacitidine

Specified dose on specified days

DRUGVenetoclax

Specified dose on specified days

Locations(16)

Yale-New Haven Hospital

New Haven, Connecticut, United States

Northwestern Memorial Hospital

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

St Louis, Missouri, United States

John Theurer Cancer Center at Hackensack University Medical Center

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

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Local Institution - 0017

Marseille, Bouches-du-Rhône, France

Local Institution - 0018

Paris, France

Local Institution - 0022

Toulouse, France

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

View Full Details on ClinicalTrials.gov

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NCT06419634

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