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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

Study Summary

This trial tests a drug to treat acute leukemia in adults. Results will show if it's safe and effective.

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of each 28 day cycle for a maximum of 32 cycles

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Biomea Fusion Inc.Lead Sponsor

4 Previous Clinical Trials

605 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent do patients experience risk during the Escalation Phase of treatment?

"A score of 1 was attributed to Escalation Phase's safety, as it is only in the initial phase and has a limited evidence base."

Answered by AI

What is the geographic breadth of this clinical trial?

"The existing 10 clinical trial sites are located in cities such as Denver, Chicago and New Orleans. It is beneficial to join the study at a site conveniently situated near you so that travel requirements stay minimal for prospective participants."

Answered by AI

What is the prime focus of this research endeavor?

"This clinical trial's primary objective is to assess the safety and tolerability of BMF-500 monotherapy by evaluating Serious Adverse Events (SAEs) over a maximum of 32 28-day cycles. Other secondary outcomes include an assessment of food on pharmacokinetic exposure, additional evidence of antitumor activity per investigator assessment, overall survival rate, and efficacy evaluation through Overall Response Rate (ORR)."

Answered by AI

Are researchers currently enrolling participants in this experiment?

"The information on clinicaltrials.gov shows that this particular trial is not currently looking for participants, as it was last modified on June 27th of 2023. However, there are around 1586 other trials actively recruiting individuals at the present moment in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Phase 1, Study of BMF-500 in Adults With Acute Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05918692.