Ph1 FIH Dose-escalation and Dose-expansion Study of BMF-219, in Adult Patients With Acute Leukemia

• Status: Recruiting
• Trial end date: 2023-06-21
• Target enrollment: 0
• Participant gender: All

Summary

Phase1 First-in-human Dose-escalation and Dose-expansion Study of BMF-219, an Oral Irreversible Menin Inhibitor, in Adult Patients With Acute Leukemia

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biomea Fusion

Criteria

Inclusion Criteria:

• Histologically or pathologically confirmed diagnosis and/or measurable Refractory or relapsed acute leukemia defined as > 5% blasts in the bone marrow or reappearance of blasts in the peripheral blood.

• Have failed or are ineligible for any approved standard of care therapies, including HSCT

• Age > 18 years

• ECOG performance status of 0-2

• Adequate liver function: total serum bilirubin ≤ 1.5 × upper limit of normal (ULN) except for Gilbert's syndrome or non-hepatic origin such as hemolysis; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 × ULN

• Adequate renal function: Estimated creatinine clearance (eCrCl) ≥ 60 mL/min using the Cockcroft-Gault equation (Cockcroft and Gault, 1976)

Exclusion Criteria:

• Diagnosis of acute promyelocytic leukemia (APL)

• Diagnosis of chronic myeloid leukemia (CML) in blast crisis

• Isolated extramedullary relapse (iEMR)

• WBC count >25,000/ µL (uncontrollable with cytoreductive therapy)

• Clinically active central nervous system (CNS) leukemia. Previously controlled CNS leukemia is acceptable

• Subjects who have undergone HSCT and have not had adequate hematologic recovery (i.e., ANC>500 and platelet count >50K

• Subjects who received chemotherapy, immunotherapy, or radiotherapy or any ancillary therapy that is considered to be investigation (i.e., used for non-approved indication and in the context of research investigation) < 14 days prior to the first dose of BMF219 or within 5 drug half-lives (whichever is shorter) prior to the first dose of study drug.

• Prior menin inhibitor therapy

• Know positive test for human immunodeficiency virus, hepatitis C or hepatitis B surface antigen