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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).
Interventions
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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