Clinical Trials Directory

Trials / Terminated

TerminatedNCT05631574

Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer

A Phase 1/1b Dose Finding Study of BMF-219, an Oral Covalent Menin Inhibitor, in Adult Patients With Unresectable, Locally Advanced, or Metastatic Non-small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PDAC), and Colorectal Cancer (CRC)

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Biomea Fusion Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGBMF-219BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.

Timeline

Start date
2023-01-12
Primary completion
2025-01-15
Completion
2025-01-15
First posted
2022-11-30
Last updated
2025-02-07

Locations

23 sites across 2 countries: United States, South Korea

Regulatory

Source: ClinicalTrials.gov record NCT05631574. Inclusion in this directory is not an endorsement.