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

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed
    • Primary completion date changed from estimate of Apr 2026 to Jan 1, 2026
    • Study completion date changed from estimate of Apr 2026 to Apr 30, 2026
    • Eligibility criteria expanded, about 12 words
  2. Primary and study completion dates: Jan 2026 to Apr 2026v9
  3. Trial status: Recruiting to Active, Not Recruitingv8 Show 5 more changesShow less
    • Enrollment target: estimated 84 to confirmed 35
    • Study sites: 23 to 14
    • Primary completion date: Jul 31, 2025 to Jan 2026
    • Study completion date: Dec 31, 2025 to Jan 2026
    • Study title revised
  4. Primary endpoints revised (6)v7 Show 7 more changesShow less
    • Enrollment target: 110 to 84
    • Study completion date: Jul 31, 2026 to Dec 31, 2025
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 9 to 7
    • Study description shortened, about 9 words
    • Site details revised at 6 of 23 sites
    • Study arms: 2 to 3
  5. Study sites: 24 to 23v6
Show 4 earlier versionsHide 4 earlier versions
  1. Site details revised at 8 of 24 sitesv5
  2. Study sites: 18 to 24v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 10 to 18
    • Start date changed from estimate of Jun 30, 2023 to Jul 26, 2023
    v3
  4. Start date: Jun 15, 2023 to Jun 30, 2023v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05918692
Lead Sponsor Biomea Fusion Inc.
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov