drugset / Trial / NCT05153330
Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2022-01-24
- Primary completion
- 2025-02-13
- Completion
- 2025-05-02
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
Stopped: “Biomea Fusion, Inc., is no longer pursuing oncology indications for BMF-219. No safety concerns or efficacy observations led to this study closure.”
release “Initial topline data from COVALENT-101 trial revealed 2 complete responses (CRs) out of 5 relapsed/refractory AML patients” biomeafusion.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | icovamenib | Small molecule | — | Oral |