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Keep this study
Lead
Biomea Fusion Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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.
Clareo Health | A Phase 1 Study of BMF-500 in Adults With Acute Leukemia
