Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer
Megadott ok: Biomea Fusion, Inc., is no longer pursuing oncology indications for BMF-219. No safety concerns or efficacy observations led to this study closure.
Key facts
- Where
- Atlanta, Buffalo, Chicago, Columbus, Denver, Encinitas, Fairfax, Goodyear, Houston, La Jolla, Miami Beach, Nashville, Omaha, Rochester, San Antonio, Seattle, St Louis és Zion, Egyesült ÁllamokSee the 19 sites
- Phase
- 1. fázis
Where in Egyesült Államok
- Cancer Treatment Centers of America - AtlantaAtlanta, Egyesült ÁllamokNo longer taking part
- Roswell Park Cancer InstituteBuffalo, Egyesült ÁllamokNo longer taking part
- Robert H. Lurie Comprehensive Cancer Center of Northwestern UniveristyChicago, Egyesült ÁllamokNo longer taking part
- Ohio State UniversityColumbus, Egyesült ÁllamokNo longer taking part
- Sarah Cannon Research Institute at HealthONEDenver, Egyesült ÁllamokNo longer taking part
- California Cancer Associates for Research and Excellence (cCARE)Encinitas, Egyesült ÁllamokNo longer taking part
- NEXT VirginiaFairfax, Egyesült ÁllamokNo longer taking part
- Cancer Treatment Centers of America, PhoenixGoodyear, Egyesült ÁllamokNo longer taking part
- The University of Texas MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- University of California San DiegoLa Jolla, Egyesült ÁllamokNo longer taking part
- Mount Sinai Comprehensive Cancer CenterMiami Beach, Egyesült ÁllamokNo longer taking part
- Tennessee OncologyNashville, Egyesült ÁllamokNo longer taking part
- Vanderbilt-Ingram Cancer CenterNashville, Egyesült ÁllamokNo longer taking part
- University of Nebraska Medical CenterOmaha, Egyesült ÁllamokNo longer taking part
- Mayo ClinicRochester, Egyesült ÁllamokNo longer taking part
- NEXT OncologySan Antonio, Egyesült ÁllamokNo longer taking part
- Fred Hutchinson Cancer CenterSeattle, Egyesült ÁllamokNo longer taking part
- Washington University School of Medicine - Siteman Cancer CenterSt Louis, Egyesült ÁllamokNo longer taking part
- Cancer Treatment Centers of America - ChicagoZion, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Biomea Fusion Inc.
- Trial code
- NCT05631574
- Record updated
- 2025. február 7.
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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.
Exclusion: 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; Concurrent malignancy in the previous 2 years; Prior menin inhibitor therapy; Requiring treatment with a strong or moderate CYP3A inhibitor/inducer; Major surgery within 4 weeks prior to first dose; Known positive test for HIV, HCV, HBV surface antigen; Significant cardiovascular disease or QTcF or QTcB prolongation; Women who are pregnant or lactating.