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NCT05918692Phase 1ACTIVE NOT RECRUITING

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

Study 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.

Conditions
Acute Myeloid Leukemia
Interventions / Drugs
BMF-500
View on ClinicalTrials.gov ↗
Sponsor
BMEA
Biomea Fusion
Covalent Small Molecules
D44/100
Study Details
Enrollment35 participants
Primary Completion—
Lead SponsorBiomea Fusion Inc.
Data Retrieved2026-04-11 04:08:06.413410+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 35 participants
Sponsor Catalyst Profile

Biomea Fusion (BMEA) is the sponsoring company for this trial. BiotechSign currently grades this company D (44/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

BMEA Full Pipeline →All Companies →
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