A Phase 1, Study of BMF-500 in Adults With Acute Leukemia
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT05918692.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not AvailableCalifornia
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not AvailableSan Francisco
University of California San Francisco
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not AvailableGeorgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not AvailableIllinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not AvailableKentucky
Lexington
University of Kentucky/Markey Cancer Center
Status: Active
Name Not AvailableMinnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not AvailableNew Jersey
Hackensack
Hackensack University Medical Center
Status: Active
Name Not AvailableNew York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not AvailableBuffalo
Roswell Park Cancer Institute
Status: Active
Name Not AvailableTexas
Houston
M D Anderson Cancer Center
Status: Active
Name Not AvailableWashington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not AvailableA 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.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationBiomea Fusion Inc.
- Primary IDCOVALENT-103
- Secondary IDsNCI-2023-06835
- ClinicalTrials.gov IDNCT05918692