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

Phase 1

Terminated

• 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
• Interventions: Drug: BMF-219

• Registration Number: NCT05631574
• Lead Sponsor: Biomea Fusion Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-20
• Study First Posted: 2022-11-30
• Study Start: 2023-01-12
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Escalation Phase	BMF-219	Dose Escalation Phase will group all disease indications (NSCLC, PDAC, and CRC) together to assess the safety of each dose level. Participants will receive escalating dose BMF-219 orally once per day or twice per day to identify the OBD/RP2D (Optimal Biologic Dose/Recommended Ph2 Dose).
Expansion Phase	BMF-219	Dose Expansion Phase will enroll additional subjects independently in each disease indication: Cohort 1: Participants with NSCLC Cohort 2: Participants with PDAC Cohort 3: Patients with CRC Cohorts 1, 2, and 3 will receive BMF-219 at the OBD/ RP2D to further assess the safety and efficacy of the investigational drug.

Primary Outcome Measures

Name	Time	Method
To determine the OBDs/RP2Ds of BMF-219 monotherapy in subjects with KRAS-driven unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.	30 months	OBD/RP2D as measured by objective response rate (ORR). ORR will be assessed using RECIST 1.1 per investigator assessment.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of BMF-219 monotherapy.	46 months	Safety and tolerability will be determined using treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as outcomes.
To evaluate the pharmacokinetics of BMF-219.	46 months	Pharmacokinetics will be determined using the AUC from time 0 to last quantifiable concentration (AUClast ).
To evaluate the efficacy of BMF-219 monotherapy in subjects with unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.	46 months	Efficacy determined by disease control rate (DCR), defined as the proportion of response-evaluable subjects who maintain disease control (Complete Response, Partial Response or SD as per RECIST 1.1) from first dose through Week 6.

Trial Locations

Locations (23)

Robert H. Lurie Comprehensive Cancer Center of Northwestern Univeristy; 🇺🇸 Chicago, Illinois, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

California Cancer Associates for Research and Excellence (cCARE); 🇺🇸 Encinitas, California, United States

Mount Sinai Comprehensive Cancer Center; 🇺🇸 Miami Beach, Florida, United States

Cancer Treatment Centers of America - Chicago; 🇺🇸 Zion, Illinois, United States

Washington University School of Medicine - Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

NEXT Virginia; 🇺🇸 Fairfax, Virginia, United States

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Cancer Treatment Centers of America - Atlanta; 🇺🇸 Atlanta, Georgia, United States

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States

Cancer Treatment Centers of America - Phoenix; 🇺🇸 Goodyear, Arizona, United States

Sarah Cannon Research Institute at HealthONE; 🇺🇸 Denver, Colorado, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

NEXT Oncology; 🇺🇸 San Antonio, Texas, United States

Severance Hospital Yonsei University Health System - PPDS; 🇰🇷 Seoul, Korea, Republic of

University of California, San Diego; 🇺🇸 La Jolla, California, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States