Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCLA UCSF
Dates
study started
completion around

Description

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.

Official Title

A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study of BMF-500, an Oral Covalent FLT3 Inhibitor, in Adults With Acute Leukemia

Details

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.

Keywords

Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Mixed-Phenotype Leukemia, FLT3, FLT3-ITD, FLT-TKD, AML, ALL, AMPL, FLT3 Wild-Type, MLL-R, NPM1, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, BMF-500

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCLA Department of Medicine accepting new patients
    Los Angeles California 90095 United States
  • University of California, Davis accepting new patients
    Sacramento California 95817 United States
  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Biomea Fusion Inc.
ID
NCT05918692
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 110 study participants
Last Updated