Trial Title:
A Phase 1, Study of BMF-500 in Adults With Acute Leukemia
NCT ID:
NCT05918692
Condition:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Acute Mixed-Phenotype Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Conditions: Keywords:
FLT3
FLT3-ITD
FLT-TKD
AML
ALL
AMPL
FLT3 Wild-Type
MLL-R
NPM1
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Accelerated Titration Design, Followed by Modified 3+3
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BMF-500
Description:
Investigational Product
Arm group label:
Escalation Phase
Arm group label:
Expansion Phase
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), acute
lymphocytic leukemia (ALL) and Acute Mixed-Phenotype Leukemia (MPAL) who may or may not
be on Antifungals.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Age ≥ 18 years.
- Individuals with histologically or pathologically confirmed diagnosis of relapsed or
refractory AML, ALL, or MPAL 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
moderate or strong CYP3A4 inhibitor (excluding other moderate or 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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
UCLA Department of Medicine
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California, Davis
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Facility:
Name:
Colorado Blood Cancer Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Winship Cancer Institute, Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Northwestern Memorial Hospital
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago Duchossois Center for Advanced Medicine (DCAM)
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Kentucky - Markey Cancer Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55902
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
John Theurer Cancer Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Montefiore Hospital - Moses Campus - BRANY - PPDs
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwell Health Cancer Institute
Address:
City:
New Hyde Park
Zip:
11042
Country:
United States
Status:
Recruiting
Facility:
Name:
East Carolina University
Address:
City:
Greenville
Zip:
27858
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Cleveland Clinic Hospital
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Oklahoma - Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology-PA USOR
Address:
City:
Dallas
Zip:
75251
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Gainesville
Zip:
20155
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Start date:
July 26, 2023
Completion date:
July 31, 2026
Lead sponsor:
Agency:
Biomea Fusion Inc.
Agency class:
Industry
Source:
Biomea Fusion Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05918692
