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Testing BMF-500 in Adults 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

Phase 1 Interventional Biomea Fusion Inc. · NCT05918692

This study is testing a new oral medication called BMF-500 to see if it can help adults with acute myeloid leukemia who have not responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment84 (estimated)
Ages18 Years and up
SexAll
SponsorBiomea Fusion Inc. Industry-sponsored
Locations23 sites (Phoenix, Arizona and 22 other locations)
Trial IDNCT05918692 on ClinicalTrials.gov

What this trial studies

This Phase 1 study evaluates BMF-500, an oral FLT3 inhibitor, in adults diagnosed with acute myeloid leukemia (AML). The trial involves a dose-escalation and dose-expansion approach to determine the safety and efficacy of BMF-500 in patients with relapsed or refractory AML, including those with specific FLT3 mutations. Participants may also be on antifungal treatments that affect drug metabolism. The study aims to gather initial data on the drug's performance in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory AML and documented FLT3 mutations.

Not a fit: Patients without a confirmed diagnosis of acute myeloid leukemia or those with other types of leukemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with acute myeloid leukemia, particularly those with FLT3 mutations.

How similar studies have performed: Other studies involving FLT3 inhibitors have shown promise in treating AML, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaFLT3FLT3-ITDFLT-TKDAMLFLT3 Wild-TypeMLL-RNPM1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.