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Tyrosine Kinase Inhibitor

BMF-500 for Leukemia

Phase 1
Recruiting
Research Sponsored by Biomea Fusion Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of each 28 day cycle for a maximum of 32 cycles
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing BMF-500, a pill that blocks a protein called FLT3, in adults with aggressive types of leukemia. The goal is to stop cancer cells from growing by blocking this protein.

Who is the study for?
Adults over 18 with acute leukemia (AML, ALL, or MPAL) that has come back or didn't respond to treatment. They must have a FLT3 mutation and be able to follow rules about using certain other drugs. People can't join if they have very high white blood cell counts, serious heart problems, recent strokes, or are pregnant.
What is being tested?
The trial is testing BMF-500, an oral drug for acute leukemia targeting the FLT3 gene mutation. It's a first-in-human study where doses will gradually increase to find safe levels before expanding to more patients.
What are the potential side effects?
Specific side effects of BMF-500 aren't listed but may include typical reactions seen with cancer treatments such as nausea, fatigue, liver issues and increased risk of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of each 28 day cycle for a maximum of 32 cycles
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of each 28 day cycle for a maximum of 32 cycles for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Evaluate the safety and tolerability of BMF-500 monotherapy by incidence of Serious Adverse Events (SAEs).
Evaluate the safety and tolerability of BMF-500 monotherapy by incidence of Treatment Emerging Adverse Events (TEAEs).
Secondary study objectives
Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.
Assess the effect of food on the PK exposure of BMF-500 in participants receiving BMF-500 (for escalation only).
Determine the pharmacokinetics of BMF-500.
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Expansion PhaseExperimental Treatment1 Intervention
BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity or who are receiving necessary azole antifungals that are moderate or strong CYP3A4 inhibitors excluding other moderate or strong CYP3A4 inhibitors.
Group II: Escalation PhaseExperimental Treatment1 Intervention
BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity or who are receiving necessary azole antifungals that are moderate or strong CYP3A4 inhibitors excluding other moderate or strong CYP3A4 inhibitors.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Myeloid Leukemia (AML) include FLT3 inhibitors, cytarabine, daunorubicin, and clofarabine. FLT3 inhibitors, such as the investigational drug BMF-500, target mutations in the FLT3 gene, which are common in AML and associated with poor prognosis. By inhibiting the FLT3 protein, these drugs can reduce the proliferation of leukemic cells. Cytarabine and daunorubicin, often used in combination, work by interfering with DNA synthesis and inducing cell death in rapidly dividing cells. Clofarabine, another chemotherapeutic agent, inhibits DNA synthesis and repair, leading to cell death. These treatments are crucial as they target the rapid and uncontrolled growth of leukemic cells, aiming to achieve remission and improve survival rates in AML patients.

Find a Location

Who is running the clinical trial?

Biomea Fusion Inc.Lead Sponsor
4 Previous Clinical Trials
645 Total Patients Enrolled

Media Library

BMF-500 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05918692 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Escalation Phase, Expansion Phase
Acute Myeloid Leukemia Clinical Trial 2023: BMF-500 Highlights & Side Effects. Trial Name: NCT05918692 — Phase 1
BMF-500 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05918692 — Phase 1
~41 spots leftby Jul 2025