A Phase 1 Study of BMF-500 in Adults With Acute Leukemia
NCT ID: NCT05918692
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
35 participants
INTERVENTIONAL
2023-07-26
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Escalation Phase
BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity.
BMF-500
Investigational Product
Arm B: Escalation Phase
BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are Strong CYP3A4 inhibitors.
BMF-500
Investigational Product
Arm C: Escalation Phase
BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are moderate CYP3A4 inhibitors.
BMF-500
Investigational Product
Interventions
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BMF-500
Investigational Product
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* WBC count \>50,000/µL (uncontrollable with cytoreductive therapy).
* Women who are pregnant or lactating or plan to become pregnant.
18 Years
ALL
No
Sponsors
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Biomea Fusion Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic
Phoenix, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
University of California, San Francisco
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Texas Oncology-PA USOR
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists
Gainesville, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Other Identifiers
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COVALENT-103
Identifier Type: -
Identifier Source: org_study_id
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