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BMF-500

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Biomea Fusion, Inc.|Last Updated: Feb 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05918692A Phase 1 Study of BMF-500 in Adults With Acute LeukemiaPHASE1 ACTIVE NOT_RECRUITING 35 — — Jul 26, 2023Apr 1, 2026Feb 23, 202614 United States
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Study Endpoints
Primary Endpoints
Evaluate the safety and tolerability of BMF-500 by incidence of Treatment Emergent Adverse Events (TEAEs).
At the end of each 28 Day cycle for a maximum of 32 cycles

Assessed by the NCI CTCAE version 5.0.

Evaluate the safety and tolerability of BMF-500 by incidence of Serious Adverse Events (SAEs).
At the end of each 28 Day cycle for a maximum of 32 cycles

Assessed by the NCI CTCAE version 5.0.

Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period

Safety, as determined by Dose-Limiting Toxicities (clinically significant Adverse Event) within each dose level assessed NCI CTCAE version 5.0.

Secondary Endpoints
Determine the pharmacokinetics of BMF-500.
At the end of each cycle (each cycle is 28 days in duration) for 7 cycles
Evaluate the efficacy of BMF-500
At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.
At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A: Escalation PhaseEXPERIMENTALBMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity.
Arm B: Escalation PhaseEXPERIMENTALBMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are Strong CYP3A4 inhibitors.
Arm C: Escalation PhaseEXPERIMENTALBMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are moderate CYP3A4 inhibitors.
Interventions
NameTypeDescription
BMF-500DRUGInvestigational Product
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

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 (includ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05918692primaryCompletionDate: changed
LOWMay 24, 2026NCT05918692studyFirstPostDate: changed