Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer
Non Small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Oral Covalent Menin Inhibitor, Relapsed, Refractory, Irreversible Menin Inhibitor, Menin Inhibitor, Unresectable, Locally Advanced, Metastatic, Menin, Menin Therapy, KRAS, KRAS Mutated
Eligibility Criteria
Inclusion Criteria 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 Criteria 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.
Sites / Locations
- Cancer Treatment Centers of America - PhoenixRecruiting
- California Cancer Associates for Research and Excellence (cCARE)Recruiting
- University of California, San Diego
- Sarah Cannon Research Institute at HealthONE
- Mount Sinai Medical Center
- Cancer Treatment Centers of America - AtlantaRecruiting
- Robert H. Lurie Comprehensive Cancer Center of Northwestern Univeristy
- Cancer Treatment Centers of America - ChicagoRecruiting
- Mayo Clinic
- Washington University School of Medicine - Siteman Cancer CenterRecruiting
- University of Nebraska Medical Center
- Roswell Park Cancer InstituteRecruiting
- Ohio State University
- Tennessee Oncology
- Vanderbilt Ingram Cancer Center
- The University of Texas MD Anderson Cancer CenterRecruiting
- NEXT OncologyRecruiting
- NEXT VirginiaRecruiting
- Fred Hutchinson Cancer CenterRecruiting
- Samsung Medical Center
- Seoul National University Hospital
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Severance Hospital Yonsei University Health System - PPDS
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Escalation Phase
Expansion Phase
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).
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.