Acute Myeloid LeukemiaPhase 1NCT05918692
A Phase 1 Study of BMF-500 in Adults With Acute Leukemia
A Phase 1 study testing BMF-500 in people with Acute Myeloid Leukemia, run by Biomea Fusion Inc. at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- BMF-500
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 14 sitesUnited States
- Study dates
- 26 Jul 2023to 30 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Individuals with histologically or pathologically confirmed diagnosis of 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 strong or moderate 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 28 days [Cycle 1]).
- 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 28 days (Cycle 1)
- 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 28 days (Cycle 1).
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Texas Oncology-PA USOR
Dallas, Texas, 75251
Colorado Blood Cancer Institute
Denver, Colorado, 80218
City of Hope National Medical Center
Duarte, California, 91010
Virginia Cancer Specialists
Gainesville, Virginia, 20155
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, 40536
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55902
University of California, San Francisco
San Francisco, California, 94143
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
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
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.
Read the detailed description
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), who may or may not be on Antifungals.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- BMF-500
- Keywords
- FLT3, FLT3-ITD, FLT-TKD, AML, FLT3 Wild-Type, MLL-R, NPM1, CYP3A4
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMF-500Drug
Investigational Product
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Escalation Phase | Experimental | BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity. Receives: Drug: BMF-500 |
| Arm B: Escalation Phase | Experimental | BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are Strong CYP3A4 inhibitors. Receives: Drug: BMF-500 |
| Arm C: Escalation Phase | Experimental | BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are moderate CYP3A4 inhibitors. Receives: Drug: BMF-500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of BMF-500 by incidence of Treatment Emergent Adverse Events (TEAEs).
Assessed by the NCI CTCAE version 5.0.
Measured: At the end of each 28 Day cycle for a maximum of 32 cycles
Evaluate the safety and tolerability of BMF-500 by incidence of Serious Adverse Events (SAEs).
Assessed by the NCI CTCAE version 5.0.
Measured: At the end of each 28 Day cycle for a maximum of 32 cycles
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Safety, as determined by Dose-Limiting Toxicities (clinically significant Adverse Event) within each dose level assessed NCI CTCAE version 5.0.
Measured: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Efficacy within each dose level as determined by composite complete remission (CRc).
Measured: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Pharmacovigilance (PK) at each dose level as determined by the maximum plasma concentration (Cmax).
Measured: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Pharmacovigilance (PK) at each dose level as determined by area under the curve plasma concentration from time 0 to last quantifiable concentration (AUClast).
Measured: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
Secondary outcomes (7)
Determine the pharmacokinetics of BMF-500.
Maximum plasma concentration (Cmax).
Measured: At the end of each cycle (each cycle is 28 days in duration) for 7 cycles
Determine the pharmacokinetics of BMF-500.
Area under the curve plasma concentration from time 0 to last quantifiable concentration (AUClast).
Measured: At the end of Cycle 1 and 2 (each cycle is 28 days in duration)
Evaluate the efficacy of BMF-500
Composite Complete Remission (CRc).
Measured: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.
Duration of Response (DOR).
Measured: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Evaluate the efficacy of BMF-500
Overall Reasons Rate (ORR).
Measured: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.
Relapse free survival (RFS).
Measured: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.
Overall Survival (OS).
Measured: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start26 Jul 2023
- Primary completion1 Jan 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Accelerated Titration Design, Followed by Modified 3+3
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomea Fusion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918692
- Sponsor's protocol ID
- COVALENT-103
- Status last verified
- Sep 2026
- First submitted
- 18 May 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05918692
- Acronym / sponsor ID
- COVALENT-103
- Conditions
- Acute Myeloid Leukemia
- Keywords
- FLT3, FLT3-ITD, FLT-TKD, AML, FLT3 Wild-Type, MLL-R, NPM1, CYP3A4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Biomea Fusion Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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), who may or may not be on Antifungals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Accelerated Titration Design, Followed by Modified 3+3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Escalation Phase | Experimental | Drug: BMF-500BMF-500 taken twice daily by participants who are not receiving drugs that inhibit CYP3A4 activity. |
| Arm B: Escalation Phase | Experimental | Drug: BMF-500BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are Strong CYP3A4 inhibitors. |
| Arm C: Escalation Phase | Experimental | Drug: BMF-500BMF-500 taken twice daily by participants who are receiving necessary azole antifungals that are moderate CYP3A4 inhibitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years.
- Individuals with histologically or pathologically confirmed diagnosis of 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMF-500Investigational Product | Drug | Arm A: Escalation Phase, Arm B: Escalation Phase, Arm C: Escalation Phase |
Primary outcome
Evaluate the safety and tolerability of BMF-500 by incidence of Treatment Emergent Adverse Events (TEAEs).
Time frame: At the end of each 28 Day cycle for a maximum of 32 cycles
Assessed by the NCI CTCAE version 5.0.
Evaluate the safety and tolerability of BMF-500 by incidence of Serious Adverse Events (SAEs).
Time frame: At the end of each 28 Day cycle for a maximum of 32 cycles
Assessed by the NCI CTCAE version 5.0.
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Time frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
Safety, as determined by Dose-Limiting Toxicities (clinically significant Adverse Event) within each dose level assessed NCI CTCAE version 5.0.
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Time frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
Efficacy within each dose level as determined by composite complete remission (CRc).
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Time frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
Pharmacovigilance (PK) at each dose level as determined by the maximum plasma concentration (Cmax).
Determine the recommended Phase 2 Dose (RP2D) of BMF-500.
Time frame: At the end of 28 day Dose-Limiting Toxicities (DLT) observation Period
Pharmacovigilance (PK) at each dose level as determined by area under the curve plasma concentration from time 0 to last quantifiable concentration (AUClast).
7 secondary outcomes
Determine the pharmacokinetics of BMF-500.
Time frame: At the end of each cycle (each cycle is 28 days in duration) for 7 cycles
Determine the pharmacokinetics of BMF-500.
Time frame: At the end of Cycle 1 and 2 (each cycle is 28 days in duration)
Evaluate the efficacy of BMF-500
Time frame: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.
Time frame: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Evaluate the efficacy of BMF-500
Time frame: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.
Time frame: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Assess additional evidence of antitumor activity per investigator assessment as per corresponding response criteria.
Time frame: At the end of each cycle (each cycle is 28 days in duration) for a maximum of 32 cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMF-500 in people with Acute Myeloid Leukemia, run by Biomea Fusion Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of BMF-500 by incidence of Treatment Emergent Adverse Events (TEAEs). (time frame: At the end of each 28 Day cycle for a maximum of 32 cycles). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.