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A Phase 1 clinical trial for adults with FLT3 mutant Acute Leukemia

About COVALENT-103

This is a multicenter, open-label, non-randomized trial seeking to examine whether BMF-500, a twice daily oral treatment, is safe and effective for patients with relapsed or refractory acute leukemia with fms-like tyrosine kinase 3 (FLT3) wild-type and FLT3 mutations. 

What is the NCT number for COVALENT-103?

The National Clinical Trial reference number is: NCT05918692 

When you talk with your doctor or clinical trial team member, please have the national trial reference number available. 

What does it mean it is open label, non-randomized?

It means all patients will receive the BMF500, the study drug and that the dose level will be pre-allocated. There will be no placebo and the allocation will not be based on chance. 

Will it cost me anything?

Study medication and study-related care will be provided at no cost. 

Patient Eligibility

18 years & over
Female & Male
R/R Leukemia with FLT3 mutations

Patients would qualify for the trial if they meet the following criteria:

  • Have not had success with standard of care treatments; refractory
  • Had cancer come back or get worse after getting better; relapsed
  • Adequate liver and renal function
  • Arm A: No CYP3A4 inhibitor for at least 7 days prior to enrollment
  • Arm B: Must have received azole antifungals that are moderate or strong CYP3A4 inhibitor for at least 7 days prior to enrollment

The science behind COVALENT-103

FLT3 is a receptor tyrosine kinase (RTK) that plays a central role in the survival, proliferation, and differentiation of immature blood cells. Notably, FLT3 gene mutations are common in patients with AML and are associated with a poor prognosis. While FLT3-specific and pan-tyrosine kinase inhibitors are approved by the FDA across various lines of therapy in AML, these agents have produced relatively low rates of durable responses and overall survival remains an unmet need. 

In preclinical study, BMF-500 demonstrated multi-fold higher potency and increased cytotoxicity than commercially available non-covalent FLT3 inhibitor as well as the potential utility of combination strategies to achieve higher cell killing with reduced concentrations of BMF-500 and BMF-219 (oral investigational covalent menin inhibitor) (Law et al. ASH 2022; Law et al. AACR 2023). These data provide preclinical evidence for combining pathway-specific inhibitors as a promising therapeutic strategy for further investigation in acute leukemia. 

What is BMF-500?

BMF-500 is an investigational, novel, orally bioavailable, highly potent and selective covalent small molecule inhibitor of FLT3. BMF-500 was designed to have a therapeutic profile to allow for combinations with standard of care and/or novel targeted agents like BMF-219. 

Contact us

If you think this clinical trial might be a good fit and you’re interested in taking part, fill out the form below or call our hotline to contact our clinical trials team.

Our clinical trials team will contact you shortly after your form submission.