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

Biomea Fusion

Status and phase: Enrolling; Phase 1

Conditions: Acute Mixed-Phenotype Leukemia; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

Treatments: Drug: BMF-500

Study type: Interventional

Funder types: Industry

Identifiers

NCT05918692

COVALENT-103

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Escalation Phase

Experimental group

Description:

BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity or who are receiving necessary azole antifungals that are moderate or strong CYP3A4 inhibitors excluding other moderate or strong CYP3A4 inhibitors.

Treatment:

Drug: BMF-500

Expansion Phase

Experimental group

Description:

BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity or who are receiving necessary azole antifungals that are moderate or strong CYP3A4 inhibitors excluding other moderate or strong CYP3A4 inhibitors.

Treatment:

Drug: BMF-500