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

Stopped early · Phase 1

Conditions studied: 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

In brief

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).

Key facts

Study ID

NCT05631574

Run by

Biomea Fusion Inc.

People needed

13

Starts

2023-01-12

Expected to finish

2025-01-15

Last updated by the study team

2025-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults with a confirmed diagnosis of unresectable, locally advanced and/or metastatic Stage IIIB/IV NSCLC, Stage III/IV PDAC and/or Stage III/IV CRC with no curative-intent treatment options and documented activating KRAS mutation (without known additional actionable driver mutations such as EGFR, ALK or ROS1)
• Documented progression and measurable disease after ≥ 1 prior line of systemic therapy (≥ 2 and
• ≤ 4 prior lines for NSCLC) with adequate washout period and resolution of treatment-related toxicities to ≤ Grade 2
• ECOG PS of 0-2 (0-1 for PDAC) and a life expectancy > 3 months in the opinion of the Investigator
• Adequate hematological, liver, and renal function
• Men and women of childbearing potential must use adequate birth control measures for the duration of the trial and at least 90 days after discontinuing study treatment

You may not qualify if…

• Symptomatic and/or untreated CNS or brain metastasis, pre-existing ILD or pericardial/pleural effusion of ≥ grade 2 or requiring chronic oxygen therapy for COPD or pleural effusions
• Serious concomitant disorder including infection
• Known positive test for HIV, HCV, HBV surface antigen
• Concurrent malignancy in the previous 2 years
• Prior menin inhibitor therapy
• Requiring treatment with a strong or moderate CYP3A inhibitor/inducer
• Significant cardiovascular disease or QTcF or QTcB prolongation.
• Major surgery within 4 weeks prior to first dose
• Women who are pregnant or lactating.

Where it is running

• Cancer Treatment Centers of America - Phoenix — Goodyear, Arizona, United States
• California Cancer Associates for Research and Excellence (cCARE) — Encinitas, California, United States
• University of California, San Diego — La Jolla, California, United States
• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Cancer Treatment Centers of America - Atlanta — Atlanta, Georgia, United States
• Robert H. Lurie Comprehensive Cancer Center of Northwestern Univeristy — Chicago, Illinois, United States
• Cancer Treatment Centers of America - Chicago — Zion, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Ohio State University — Columbus, Ohio, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• NEXT Oncology — San Antonio, Texas, United States
• NEXT Virginia — Fairfax, Virginia, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital Yonsei University Health System - PPDS — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.