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

• Status: Recruiting
• Trial end date: 2026-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biomea Fusion Inc.

Criteria

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.