NCT06419634

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 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
53mo left

Started May 2024

Longer than P75 for phase_1

Geographic Reach
4 countries

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
May 2024Sep 2030

First Submitted

Initial submission to the registry

May 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

May 29, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2030

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

May 14, 2024

Last Update Submit

April 3, 2026

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Keywords

BMS-986497First-in-HumanORM-6151Acute myeloid leukemia (AML)Myelodysplastic syndrome (MDS)Cluster of differentiation 33 (CD33)G1 to S phase transition 1 (GSPT1)Open label study

Outcome Measures

Primary Outcomes (5)

  • 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) of BMS-986497 as Monotherapy

    Up to 2 years

  • RP2D of BMS-986497 as Combination Therapy

    The combination therapy included BMS-986497 and Azacitidine

    Up to 2 years

  • RP2D of BMS-986497 as Triple Combination Therapy

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

    Up to 2 years

Secondary Outcomes (12)

  • Maximum concentration (Cmax)

    Up to 2 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

  • Overall response rate (ORR)

    Up to 4 years

  • Duration of response (DoR)

    Up to 4 years

  • +7 more secondary outcomes

Study Arms (3)

Part 1: Dose Escalation BMS-986497 (Monotherapy)

EXPERIMENTAL
Drug: BMS-986497

Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)

EXPERIMENTAL
Drug: BMS-986497Drug: Azacitidine

Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)

EXPERIMENTAL
Drug: BMS-986497Drug: AzacitidineDrug: Venetoclax

Interventions

BMS-986497DRUG

Specified dose on specified days

Also known as: ORM-6151
Part 1: Dose Escalation BMS-986497 (Monotherapy)Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)
AzacitidineDRUG

Specified dose on specified days

Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)
VenetoclaxDRUG

Specified dose on specified days

Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Acute Promyelocytic Leukemia.
  • Clinically active central nervous system leukemia.
  • Active malignant solid tumor.
  • Pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Local Institution - 0007

Boston, Massachusetts, 02114, United States

WITHDRAWN

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Washington University School of Medicine, Siteman Cancer Center

St Louis, Missouri, 63108, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

WITHDRAWN

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Local Institution - 0009

Fairfax, Virginia, 22031, United States

WITHDRAWN

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Local Institution - 0017

Marseille, Bouches-du-Rhône, 13273, France

NOT YET RECRUITING

Local Institution - 0018

Paris, 75010, France

NOT YET RECRUITING

Local Institution - 0022

Toulouse, 31100, France

NOT YET RECRUITING

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], 08036, Spain

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

Azacitidinevenetoclax

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

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

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

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 17, 2024

Study Start

May 29, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 16, 2030

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations

CA(2)US(9)FR(3)ES(2)