A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study of BMF-500, an Oral Covalent FLT3 Inhibitor, in Adults With Acute Leukemia
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
United States
Arizona
Mayo Clinic
RECRUITING
Phoenix
California
City of Hope National Medical Center
RECRUITING
Duarte
UCLA Department of Medicine
RECRUITING
Los Angeles
University of California, Davis
RECRUITING
Sacramento
University of California, San Francisco
RECRUITING
San Francisco
Colorado
Colorado Blood Cancer Institute
RECRUITING
Denver
Florida
Mayo Clinic
RECRUITING
Jacksonville
Georgia
Winship Cancer Institute, Emory University
RECRUITING
Atlanta
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
University of Chicago Duchossois Center for Advanced Medicine (DCAM)
RECRUITING
Chicago
Kentucky
University of Kentucky - Markey Cancer Center
RECRUITING
Lexington
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
East Carolina University
NOT_YET_RECRUITING
Greenville
New Jersey
John Theurer Cancer Center
RECRUITING
Hackensack
New York
Roswell Park Comprehensive Cancer Center
RECRUITING
Buffalo
Northwell Health Cancer Institute
RECRUITING
New Hyde Park
Montefiore Hospital - Moses Campus - BRANY - PPDs
RECRUITING
The Bronx
Ohio
Cleveland Clinic Hospital
RECRUITING
Cleveland
Oklahoma
University of Oklahoma - Stephenson Cancer Center
RECRUITING
Oklahoma City
Texas
Texas Oncology-PA USOR
RECRUITING
Dallas
MD Anderson Cancer Center
RECRUITING
Houston
Virginia
Virginia Cancer Specialists
RECRUITING
Gainesville
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Contact Information
Primary
Mona Vimal
clinicaltrials@biomeafusion.com
1-844-245-0490
Backup
Steve Morris, MD
clinicaltrials@biomeafusion.com
1-844-245-0490
Time Frame
Start Date:2023-07-26
Estimated Completion Date:2025-12-31
Participants
Target number of participants:84
Treatments
Experimental: Arm A: Escalation Phase
BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity.
Experimental: Arm B: Escalation Phase
BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are Strong CYP3A4 inhibitors.
Experimental: Arm C: Escalation Phase
BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are moderate CYP3A4 inhibitors.