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Clinical Trial Summary

A Phase 1/1b dose finding study to determine the OBD(s) and RP2D(s) of BMF-219, a covalent menin inhibitor small molecule, in subjects with KRAS mutated unresectable, locally advanced, or metastatic NSCLC (Cohort 1), PDAC (Cohort 2), and CRC (Cohort 3).


Clinical Trial Description

This is a dose finding study to determine the safety and tolerability, pharmacokinetics and pharmacodynamics, and clinical activity of escalating doses of BMF-219 administered orally (PO) either once daily (QD) or twice daily (BID) in 28-day cycles. After observing acceptable safety performance in these dosing regimens, additional subjects will be enrolled to assess efficacy in the determination of the OBD for use as a RP2D. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Cancer
  • Colorectal Neoplasms
  • CRC
  • KRAS Mutation-Related Tumors
  • Lung Neoplasms
  • Non Small Cell Lung Cancer
  • NSCLC
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • PDAC
  • Refractory Cancer
  • Relapsed Cancer
  • Stage III Colorectal Cancer
  • Stage III Non-small Cell Lung Cancer
  • Stage III NSCLC
  • Stage III Pancreatic Cancer
  • Stage IV Colorectal Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Stage IV NSCLC
  • Stage IV Pancreatic Cancer

NCT number NCT05631574
Study type Interventional
Source Biomea Fusion Inc.
Contact Alex Cacovean, MD
Phone 1-844-245-0490
Email clinicaltrials@biomeafusion.com
Status Recruiting
Phase Phase 1
Start date January 12, 2023
Completion date October 2026

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