A Phase 1, Study of BMF-500 in Adults With Acute Leukemia
18 Years and older, Male and Female
COVALENT-103 (primary)
NCI-2023-06835
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.
Objectives
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.
Eligibility
- 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
Treatment Sites in Georgia
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