ACTIVE_NOT_RECRUITING

A Phase 1 Study of BMF-500 in Adults With Acute Leukemia

Conditions

Acute Myeloid Leukemia FLT3 FLT3-ITD FLT-TKD AML FLT3 Wild-Type MLL-R NPM1 CYP3A4

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-07-26

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05918692

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Locations (Sites)

Mayo Clinic

Phoenix, Arizona, 85054

United States

City of Hope National Medical Center

Duarte, California, 91010

United States

University of California, San Francisco

San Francisco, California, 94143

United States

Colorado Blood Cancer Institute

Denver, Colorado, 80218

United States

Mayo Clinic

Jacksonville, Florida, 32224

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322

United States

Northwestern Memorial Hospital

Chicago, Illinois, 60611

United States

University of Kentucky - Markey Cancer Center

Lexington, Kentucky, 40536

United States

Mayo Clinic

Rochester, Minnesota, 55902

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203

United States

Texas Oncology-PA USOR

Dallas, Texas, 75251

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Virginia Cancer Specialists

Gainesville, Virginia, 20155

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Biomea Fusion Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-26

Study Completion Date2026-01

Study Record Updates

Study Start Date2023-07-26

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

FLT3
FLT3-ITD
FLT-TKD
AML
FLT3 Wild-Type
MLL-R
NPM1
CYP3A4

Additional Relevant MeSH Terms

Acute Myeloid Leukemia