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
NCT03785249
Institution Name
Multiple Sites (See Below)
Institution Country
United States
Additional Institutions
United State, Alabama
  • 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
Principal Investigator
Multiple Sites
Principal Investigator Phone
(844) 893-5530
Principal Investigator Email
miratistudylocator@emergingmed.com
Additional Principal Investigators
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
Study Overview
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 Information
565 participants
Study Start Date
20190930
Study End Date
20240930
Study Purpose
  • 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
  • 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
  • History of intestinal disease or major gastric surgery or inability to swallow oral medications
  • Other active cancer
Required Tests Prior to Study
KRASG12C mutation, which will be identified by the healthcare team
Financial Assistance Available
Yes