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New pill targets leukemia in early human trial

NCT ID NCT05918692

Disease control Sponsor: Biomea Fusion Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental pill called BMF-500 in 35 adults with acute leukemia, especially those with a specific genetic mutation (FLT3). The main goals are to check the drug's safety, find the right dose, and see if it can help control the disease. Participants must have leukemia that has come back or not improved after prior treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BMF-500 (an oral FLT3 inhibitor)
What this could lead to
If successful, this could lead to a new targeted treatment option for patients with acute leukemia that has returned or not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 35 participants, so it is primarily testing safety and dosing. The drug may not prove effective or could have significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

35 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion 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). 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.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia

Contacts and locations

Locations

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14203, United States

  • Texas Oncology-PA USOR

    Dallas, Texas, 75251, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Kentucky - Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • Virginia Cancer Specialists

    Gainesville, Virginia, 20155, United States

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.