A Phase 1 Study of BMF-500 in Adults 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), who may or may not be on Antifungals.

Key Inclusion Criteria:

• Age ≥ 18 years.
• Individuals with histologically or pathologically confirmed diagnosis of 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 strong or moderate 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 28 days [Cycle 1]).
• 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 28 days (Cycle 1)
• 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 28 days (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.