A Phase 1, Study of BMF-500 in Adults With Acute Leukemia

Description

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, Acute Lymphoblastic Leukemia, Acute Mixed-Phenotype Leukemia

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Study Overview

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Study Details

Study overview

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.

A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study of BMF-500, an Oral Covalent FLT3 Inhibitor, in Adults With Acute Leukemia

A Phase 1, Study of BMF-500 in Adults With Acute Leukemia

Condition
Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic, Phoenix, Arizona, United States, 85054

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Los Angeles

UCLA Department of Medicine, Los Angeles, California, United States, 90095

Sacramento

University of California, Davis, Sacramento, California, United States, 95817

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Atlanta

Winship Cancer Institute, Emory University, Atlanta, Georgia, United States, 30322

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Chicago

University of Chicago Duchossois Center for Advanced Medicine (DCAM), Chicago, Illinois, United States, 60637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years.
  • * Individuals with histologically or pathologically confirmed diagnosis of relapsed or refractory AML, ALL, or MPAL 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 moderate or strong CYP3A4 inhibitor (excluding other moderate or 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Biomea Fusion Inc.,

Study Record Dates

2026-07-31