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

Active:	Yes
Cancer Type:	Colon/Rectal Cancer Lung Cancer	NCT ID:	NCT05631574
Trial Phases:	Phase I	Protocol IDs:	COVALENT-102 (primary) NCI-2023-01290
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Biomea Fusion Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05631574

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).

Objectives

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.

Treatment Sites in Georgia

City of Hope Atlanta
600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

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