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

Biomea Fusion

Status and phase: Enrolling; Phase 1

Conditions: 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), who may or may not be on Antifungals.

Enrollment: 84 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 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 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 4 weeks.
• 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 4 weeks (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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 3 patient groups

Arm A: Escalation Phase

Experimental group

Description:

BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity.

Treatment:

Drug: BMF-500

Arm B: Escalation Phase

Experimental group

Description:

BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are Strong CYP3A4 inhibitors.

Treatment:

Drug: BMF-500

Arm C: Escalation Phase

Experimental group

Description:

BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are moderate CYP3A4 inhibitors.

Treatment:

Drug: BMF-500