This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.

Study Name This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation. ClinicalTrials.gov Identifier (if applicable) NCT03785249 Clinical Trial Category (check all that apply) Beyond First Line Therapy Targeted Therapy Study Center Institution Name Multiple Sites (See Below) State – Please Select – Country United States List additional Institutions (include address, phone number, and website) Please visit https://clinicaltrials.gov/ct2/show/NCT03785249 for the latest information University of Alabama at Birmingham Recruiting Birmingham, Alabama, United States, 35294 United States, Alaska Alaska Oncology and Hematology Recruiting Anchorage, Alaska, United States, 99508 United States, Arizona Mayo Clinic in Arizona Recruiting Phoenix, Arizona, United States, 85054 Arizona Oncology Associates Recruiting Tucson, Arizona, United States, 85704 United States, California Kaiser Permanente-Bellflower Medical Offices Recruiting Bellflower, California, United States, 90706 Beverly Hills Cancer Center Recruiting Beverly Hills, California, United States, 90211 City of Hope Recruiting Duarte, California, United States, 91010 St. Joseph Heritage Healthcare Recruiting Fullerton, California, United States, 92835 University of California San Diego Moores Cancer Center Recruiting La Jolla, California, United States, 92093 Hoag Memorial Hospital Presbyterian Recruiting Newport Beach, California, United States, 92663 University of California, Irvine Recruiting Orange, California, United States, 92868 California Cancer Associates for Research and Excellence Recruiting San Diego, California, United States, 92111 Ridley – Tree Cancer Center – Santa Barbara Recruiting Santa Barbara, California, United States, 93105 Kaiser Permanente Recruiting Vallejo, California, United States, 94589 United States, Colorado Rocky Mountain Cancer Centers Recruiting Aurora, Colorado, United States, 80012 University of Colorado Hospital Recruiting Aurora, Colorado, United States, 80045 St. Mary’s Hospital & Regional Medical Center – Research Recruiting Grand Junction, Colorado, United States, 81501 United States, Connecticut Yale Cancer Center Recruiting New Haven, Connecticut, United States, 06511 United States, Delaware Medical Oncology Hematology Consultants Recruiting Newark, Delaware, United States, 19713 United States, Florida Mayo Clinic in Florida Recruiting Jacksonville, Florida, United States, 32224 Mount Sinai Comprehensive Cancer Center Recruiting Miami Beach, Florida, United States, 33140 Miami Cancer Institute Baptist Health Recruiting Miami, Florida, United States, 33176 Mid Florida Hematology and Oncology Center Recruiting Orange City, Florida, United States, 37263 Woodlands Medical Specialists Recruiting Pensacola, Florida, United States, 32503 BRCR Medical Center Recruiting Plantation, Florida, United States, 33322 United States, Georgia Northwest Georgia Oncology Centers, PC Recruiting Marietta, Georgia, United States, 30060 United States, Illinois Illinois Cancer Specialists – Niles Recruiting Niles, Illinois, United States, 60714 United States, Iowa University of Iowa Hospital & Clinics Recruiting Iowa City, Iowa, United States, 52242 United States, Kansas University of Kansas Medical Center Recruiting Westwood, Kansas, United States, 66205 United States, Kentucky University of Kentucky Recruiting Lexington, Kentucky, United States, 40536 United States, Maine Main Health Cancer Center Biddeford Recruiting Biddeford, Maine, United States, 04005 United States, Maryland Maryland Oncology Hematology-Columbia Recruiting Columbia, Maryland, United States, 21044 United States, Massachusetts Massachusetts General Hospital Recruiting Boston, Massachusetts, United States, 02114 Dana Farber Cancer Institute Recruiting Boston, Massachusetts, United States, 02215 United States, Michigan Henry Ford Medical Center Recruiting Detroit, Michigan, United States, 48377 United States, Minnesota Minnesota Oncology Recruiting Minneapolis, Minnesota, United States, 55102 University of Minnesota Recruiting Minneapolis, Minnesota, United States, 55454 Mayo Clinic in Minnesota Recruiting Rochester, Minnesota, United States, 55905 Metro-Minnesota Community Oncology Research Consortium Recruiting Saint Louis Park, Minnesota, United States, 55416 United States, Missouri Goldschmidt Cancer Center- Central Region Medical Center Recruiting Jefferson City, Missouri, United States, 65109 United States, Montana Frontier Cancer Center Recruiting Billings, Montana, United States, 59102 United States, Nebraska Nebraska Cancer Specialists Recruiting Omaha, Nebraska, United States, 68130 University of Nebraska Medical Center Recruiting Omaha, Nebraska, United States, 68198 United States, Nevada Comprehensive Cancer Centers of Nevada Recruiting Las Vegas, Nevada, United States, 89169 United States, New York Roswell Park Recruiting Buffalo, New York, United States, 14263 Perlmutter Cancer Center Recruiting New York, New York, United States, 10016 Memorial Sloan Kettering Cancer Center Recruiting New York, New York, United States, 10065 United States, North Carolina University of North Carolina Recruiting Chapel Hill, North Carolina, United States, 27514 FirstHealth Outpatient Cancer Center Recruiting Pinehurst, North Carolina, United States, 28374 United States, Ohio University of Cincinnati Health Barrett Cancer Center Recruiting Cincinnati, Ohio, United States, 45219 Cleveland Clinic Recruiting Cleveland, Ohio, United States, 44195 OSU Medical Center Recruiting Columbus, Ohio, United States, 43210 Kettering Cancer Center Recruiting Kettering, Ohio, United States, 45429 United States, Oregon Willamette Valley Cancer Institute and Research Center – Eugene Recruiting Eugene, Oregon, United States, 97401 United States, Pennsylvania Lehigh Valley Heath Recruiting Allentown, Pennsylvania, United States, 18103 Penn State Health Milton S. Hershey Medical Center Recruiting Hershey, Pennsylvania, United States, 17033 United States, South Carolina Charleston Oncology P.A. Recruiting Charleston, South Carolina, United States, 29414 Medical University of South Carolina Recruiting Charleston, South Carolina, United States, 29425 United States, Tennessee Tennessee Oncology/The Sarah Cannon Research Institute Recruiting Nashville, Tennessee, United States, 37203 United States, Texas Texas Oncology-Arlington Recruiting Arlington, Texas, United States, 76014 USOR – Texas Oncology – Austin Central Recruiting Austin, Texas, United States, 78731 Mary Crowley Cancer Research Recruiting Dallas, Texas, United States, 75231 Texas Oncology at Presbyterian Dallas Recruiting Dallas, Texas, United States, 75231 USOR Texas Oncology Baylor Charles A. Sammons Cancer Center Recruiting Dallas, Texas, United States, 75246 Texas Oncology Recruiting Fort Worth, Texas, United States, 76104 The University of Texas MD Anderson Cancer Center Recruiting Houston, Texas, United States, 77030 South Texas Accelerated Research Therapeutics Recruiting San Antonio, Texas, United States, 78229 Texas Oncology Recruiting Sugar Land, Texas, United States, 77479 Texas Oncology Recruiting Tyler, Texas, United States, 75702 United States, Virginia Virginia Cancer Specialists Recruiting Fairfax, Virginia, United States, 22031 Virginia Oncology Associates-Newport News Recruiting Newport News, Virginia, United States, 23606 United States, Washington Seattle Cancer Care Alliance Recruiting Seattle, Washington, United States, 98109 USOR – Compass Oncology – Vancouver Recruiting Vancouver, Washington, United States, 98684 United States, Wisconsin University of Wisconsin Carbone Cancer Center Recruiting Madison, Wisconsin, United States, 53792 Puerto Rico PanOncology Trials Recruiting San Juan, Puerto Rico, 00935 Study Contacts Principal Investigator Multiple Sites P.I. Phone (844) 893-5530 P.I. Email miratistudylocator@emergingmed.com List additional Principal Investigators (include phone number and email) Please visit https://clinicaltrials.gov/ct2/show/NCT03785249 for the latest information Study Coordinator Mirati Therapeutics Study Locator Services Study Coordinator Phone (844) 893-5530 Study Coordinator Email miratistudylocator@emergingmed.com OVERVIEW – in layman’s terms (150 words max) This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation. Enrollment 565 participants Study Start Date 01/15/2019 Estimated Completion Date 9/30/2024 Purpose of the Study – in Layman’s Terms (use the “+” to add more list items) This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C. Inclusion Criteria – Patients Must: Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation Unresectable or metastatic disease Standard treatment is not available or patient declines Adequate organ function Exclusion Criteria – Patients Must NOT: History of intestinal disease or major gastric surgery or inability to swallow oral medications Other active cancer REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms KRASG12C mutation, which will be identified by the healthcare team