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Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT05153330
Phase: Phase I
Principal Investigator: Lancet, Jeffrey
A Phase 1 First-in-Human Dose-escalation and Dose-expansion Study of BMF-219, an Oral Irreversible Menin Inhibitor, in Adult Patients with Acute Leukemia Including Those with an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF 219, an oral irreversible menin inhibitor, in adult patients with acute leukemia (AL), diffuse large B-cell lymphoma (DLBCL), and multiple myeloma (MM)
1. Determine the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 monotherapy; 2. Evaluate the safety as expressed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs); 3. Determine maximum observed plasma concentration (Cmax), time to reach maximum observed concentration (Tmax), and area under plasma-concentration time curve from time 0 to time of last quantifiable concentration (AUC0-last) of BMF-219; 4. Evaluate the efficacy of BMF-219 as measured by complete remission rate (CRR) per Investigator assessment; 5. Assess additional evidence of antitumor activity.
Therapy (NOS)
BMF-219 ()
Inclusion Criteria:
Exclusion criteria:
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