Status and phase
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About
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL.
Full description
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) with mixed lineage leukemia 1-rearranged (KMT2A/ MLL1r), nucleophosmin 1 (NPM1), diffuse large b-cell lymphoma (DLBCL), multiple myeloma (MM), and chronic lymphocytic lymphoma (CLL)/ small lymphocytic lymphoma (SLL).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age ≥ 18 years.
All subjects must have histologically or pathologically confirmed diagnosis of their malignancy and/ or measurable R/ R disease, as follows:
Subjects must be refractory or must have progressed on, or following discontinuation of the most recent anti-cancer therapy, with the following considerations:
ECOG performance status of 0-2 and an estimated expected life expectancy of > 3 months in the opinion of the Investigator.
Adequate organ function.
Both men and women of childbearing potential or their partners must use adequate birth control measures during the course of the trial and for at least 90 days after discontinuing study treatment.
Exclusion criteria
Subjects who meet any of the following criteria will not be enrolled in the study (all cohorts, unless otherwise indicated):
Certain disease subtypes or occurrences, as follows:
White Blood Count (WBC) > 50,000/μL (uncontrollable with cytoreductive therapy) (Cohort 1 only).
Known central nervous involvement, as follows:
Prior menin inhibitor therapy.
Known positive test for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen.
Subjects with a pre-existing disorder predisposing them to a serious or life-threatening infection.
An active uncontrolled acute or chronic systemic fungal, bacterial, or viral infection.
Primary purpose
Allocation
Interventional model
Masking
177 participants in 2 patient groups
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Central trial contact
Clarissa Mandap; Mona Vimal
Data sourced from clinicaltrials.gov
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