ClinicalTrials.Veeva

Menu

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

B

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)

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

Trial contacts and locations

23

Loading...

Central trial contact

Steve Morris, MD; Mona Vimal

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems