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A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study of BMF-500, an Oral Covalent FLT3 Inhibitor, 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.A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-500, an oral covalent FLT3 inhibitor, in adult patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and Acute Mixed-Phenotype Leukemia (MPAL) who may or may not be on Antifungals.

Trial Eligibility

Key Inclusion 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. 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 Info

Organization

Biomea Fusion Inc.


Primary Outcome

Evaluate the safety and tolerability of BMF-500 monotherapy by incidence of Treatment Emerging Adverse Events (TEAEs).


Outcome Timeframe At the end of each 28 Day cycle for a maximum of 32 cycles

NCTID NCT05918692

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2023-07-26

Completion Date 2025-07-31

Enrollment Target 110

Interventions

DRUG BMF-500

Locations Recruiting

Mayo Clinic

United States, Arizona, Phoenix


City of Hope National Medical Center

United States, California, Duarte


UCLA Department of Medicine

United States, California, Los Angeles


University of California, Davis

United States, California, Sacramento


University of California, San Francisco

United States, California, San Francisco


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