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

NCT05631574 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-02-07

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

BMF-219

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

Sponsors & Collaborators

  • Biomea Fusion Inc.

    lead INDUSTRY

Principal Investigators

  • Steve Morris, MD · Biomea Fusion Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2025-01-15
Completion
2025-01-15
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05631574 on ClinicalTrials.gov