A Phase 1, Study of BMF-500 in Adults With Acute Leukemia
- Registration Number
- NCT05918692
- Lead Sponsor
- Biomea Fusion Inc.
- Brief 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.
- Detailed Description
A 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Escalation Phase BMF-500 BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity. Arm B: Escalation Phase BMF-500 BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are Strong CYP3A4 inhibitors. Arm C: Escalation Phase BMF-500 BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are moderate CYP3A4 inhibitors.
- Primary Outcome Measures
Name Time Method 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 Pharmacovigilance (PK) at each dose level as determined by area under the curve plasma concentration from time 0 to last quantifiable concentration (AUClast).
- Secondary Outcome Measures
Name Time Method Determine the pharmacokinetics of BMF-500. At the end of Cycle 1 and 2 (each cycle is 28 days in duration) Area under the curve plasma concentration from time 0 to last quantifiable concentration (AUClast).
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 Overall Reasons Rate (ORR).
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 Overall Survival (OS).
Trial Locations
- Locations (21)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
UCLA Department of Medicine
🇺🇸Los Angeles, California, United States
University of California, Davis
🇺🇸Sacramento, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Chicago Duchossois Center for Advanced Medicine (DCAM)
🇺🇸Chicago, Illinois, United States
University of Kentucky - Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
John Theurer Cancer Center
🇺🇸Hackensack, New Jersey, United States
Montefiore Hospital - Moses Campus - BRANY - PPDs
🇺🇸Bronx, New York, United States
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
Northwell Health Cancer Institute
🇺🇸New Hyde Park, New York, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Cleveland Clinic Hospital
🇺🇸Cleveland, Ohio, United States
University of Oklahoma - Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, 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