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Not recruiting
Phase 1

BMF-500

Sponsor:

Biomea Fusion Inc.

Code:

NCT05918692

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMF-500

Study Details

Brief summary:

A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-500, an oral FLT3 inhibitor, in adult patients with acute leukemia.

Conditions

Acute Myeloid Leukemia

Study ID

NCT05918692

Start date

Jul 26, 2023

Status verified date

Apr, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Jul 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Age ≥ 18 years.
  • Individuals with histologically or pathologically confirmed diagnosis of relapsed or refractory AML with documented FLT3 mutation, and/or Individuals with histologically or pathologically confirmed diagnosis of their malignancy with wild-type FLT3 (including those with MLL1-R and NPM1 mutations).
  • ECOG performance status of 0-2.
  • Adequate liver and renal function
  • Adhere to the CYP3A4 inhibitor concomitant therapy use requirements, as follows:
  • Arm A: Participants must not have received a moderate or strong CYP3A4 inhibitor for at least 7 days prior to enrollment and are not anticipated to require such agents in the near term (for at least 4 weeks).
  • Arm B: Participants must have received a necessary azole antifungal(s) that is a strong CYP3A4 inhibitor (excluding other strong CYP3A4 inhibitor\[s\]) for at least 7 days prior to enrollment and be able to continue such azole antifungal(s) while on BMF-500 treatment for at least 4 weeks.
  • Arm C: Participants must have received necessary azole antifungal(s) that are moderate CYP3A4 inhibitors (excluding other moderate CYP3A4 inhibitors) for at least 7 days prior to enrollment and be able to continue such azole antifungal(s) while on BMF-500 treatment for at least 4 weeks (Cycle 1).

Key Exclusion Criteria:

  • Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, history of cerebrovascular accident including transient ischemic attack within 6 months prior to the first dose of the trial intervention.
  • WBC count >50,000/µL (uncontrollable with cytoreductive therapy).
  • Women who are pregnant or lactating or plan to become pregnant.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Escalation Phase

BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity.

experimental: Arm B: Escalation Phase

BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are Strong CYP3A4 inhibitors.

experimental: Arm C: Escalation Phase

BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are moderate CYP3A4 inhibitors.

Interventions

BMF-500

Investigational Product

Primary outcome measure

  • Evaluate the safety and tolerability of BMF-500 by incidence of Treatment Emergent Adverse Events (TEAEs). [ Time Frame: At the end of each 28 Day cycle for a maximum of 32 cycles ]
  • Evaluate the safety and tolerability of BMF-500 by incidence of Serious Adverse Events (SAEs). [ Time Frame: At the end of each 28 Day cycle for a maximum of 32 cycles ]
  • Determine the recommended Phase 2 Dose (RP2D) of BMF-500. [ Time Frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period ]
  • Determine the recommended Phase 2 Dose (RP2D) of BMF-500. [ Time Frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period ]
  • Determine the recommended Phase 2 Dose (RP2D) of BMF-500. [ Time Frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period ]
  • Determine the recommended Phase 2 Dose (RP2D) of BMF-500. [ Time Frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period ]

Central Contacts and Locations

Central contacts

Mona Vimal

1-844-245-0490clinicaltrials@biomeafusion.com

Steve Morris, MD

1-844-245-0490clinicaltrials@biomeafusion.com

Locations

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010

UCLA Department of Medicine

Recruiting

Los Angeles, California, United States, 90095

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Winship Cancer Institute, Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

University of Chicago Duchossois Center for Advanced Medicine (DCAM)

Recruiting

Chicago, Illinois, United States, 60637

University of Kentucky - Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

John Theurer Cancer Center

Recruiting

Hackensack, New Jersey, United States, 07601

Montefiore Hospital - Moses Campus - BRANY - PPDs

Recruiting

Bronx, New York, United States, 10467

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14203

Northwell Health Cancer Institute

Recruiting

New Hyde Park, New York, United States, 11042

Cleveland Clinic Hospital

Recruiting

Cleveland, Ohio, United States, 44195

University of Oklahoma - Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Texas Oncology-PA USOR

Recruiting

Dallas, Texas, United States, 75251

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Virginia Cancer Specialists

Recruiting

Gainesville, Virginia, United States, 20155

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

More Information

Sponsor

Biomea Fusion Inc.

Last update posted

Apr 6, 2025

Last verified

Apr, 2025

Keywords

  • FLT3
  • FLT3-ITD
  • FLT-TKD
  • AML
  • FLT3 Wild-Type
  • MLL-R
  • NPM1
  • CYP3A4

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Biomea Fusion Inc. on 2025-04-06.