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Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

Program Status

Recruiting

Phase

PHASE1 PHASE2

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

afatinib, cetuximab, MRTX849, Pembrolizumab

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Key inclusion/ exclusion criteria: patient needs to have a KRAS p.G12C mutation. October 2019: one CRC patient response. See Helpful Links
Even if not exclusive for CRC, important, given the specific targeting of the mutation. Other trial targeting KRAS G12C: NCT03600883
Update: combination arm with cetuximab.
Update 2022: has results. “32 patients with CRC cancer with the KRASG12C mutation were treated with adagrasib and cetuximab. The ORR was 46% among 28 evaluable patients and DCR was 100%, and median PFS was 6.9 month (median prior lines of systemic therapy was 3)”.

Location Location Status
United States
ONeal Comprehensive Cancer Center at the University of Alabama at Birmingham
Birmingham, Alabama 35294
RECRUITING
Alaska Oncology and Hematology
Anchorage, Alaska 99508
RECRUITING
Mayo Clinic Arizona - Phoenix Campus
Phoenix, Arizona 85054
RECRUITING
Local Institution - 001-807
Scottsdale, Arizona 85258
WITHDRAWN
USOR - Arizona Oncology - Tucson - Rudasill
Tucson, Arizona 85704
RECRUITING
Beverly Hills Cancer Center
Beverly Hills, California 90211
RECRUITING
City of Hope - Duarte (Main Campus)
Duarte, California 91010
RECRUITING
Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton
Fullerton, California 92835
RECRUITING
University of California San Diego Moores Cancer Center
La Jolla, California 92093
RECRUITING
TRIO - Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
RECRUITING
Southern California Permanente Medical Group - Los Angeles Medical Center
Los Angeles, California 90027
RECRUITING
Valkyrie Clinical Trials
Los Angeles, California 90067
RECRUITING
Hoag Memorial Hospital Presbyterian - Newport Beach
Newport Beach, California 92663
RECRUITING
University of California Irvine Medical Center
Orange, California 92868
RECRUITING
California Cancer Associates for Research and Excellence (cCARE) - San Diego 4S Ranch
San Diego, California 92111
RECRUITING
Ridley - Tree Cancer Center - Santa Barbara
Santa Barbara, California 93105
RECRUITING
Kaiser Permanente - Vallejo Medical Center
Vallejo, California 94589
RECRUITING
Local Institution - 001-872
Aurora, Colorado 80012
NOT_YET_RECRUITING
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
Aurora, Colorado 80045
RECRUITING
Cancer Centers of Colorado - St. Marys Regional Hospital
Grand Junction, Colorado 81501
RECRUITING
SCL Health - Saint Joseph Hospital Cancer Center
Lafayette, Colorado 80026
RECRUITING
Yale Cancer Center
New Haven, Connecticut 06510
RECRUITING
USOR - Medical Oncology Hematology Consultants
Newark, Delaware 19713-2055
RECRUITING
SCRI - Florida Cancer Specialists - South Region Research Office
Fort Myers, Florida 33901
RECRUITING
Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
RECRUITING
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
RECRUITING
Miami Cancer Institute
Miami, Florida 33176
RECRUITING
Florida Cancer Affiliates - Ocala - Main
Ocala, Florida 34474
RECRUITING
Mid Florida Cancer Centers - Orange City
Orange City, Florida 32763
RECRUITING
Woodlands Medical Specialists
Pensacola, Florida 32503
RECRUITING
SCRI - Florida Cancer Specialists - North Region Research Office
Saint Petersburg, Florida 33705
RECRUITING
SCRI - Florida Cancer Specialists - East Region Research Office
West Palm Beach, Florida 33401
RECRUITING
University Cancer & Blood Center (UCBC) - Athens
Athens, Georgia 30607
RECRUITING
Northwest Georgia Oncology Centers Wellstar - Marietta
Marietta, Georgia 30060
RECRUITING
Affiliated Oncologists - Millenium Medical Center - Chicago Ridge
Chicago Ridge, Illinois 60415
RECRUITING
Local Institution - 001-828
Chicago, Illinois 60611
WITHDRAWN
USOR - Illinois Cancer Specialists - Niles
Niles, Illinois 60714
RECRUITING
Memorial Hospital
South Bend, Indiana 46601
RECRUITING
Local Institution - 001-831
Iowa City, Iowa 52242
NOT_YET_RECRUITING
University of Kansas Medical Center
Westwood, Kansas 66205
RECRUITING
University of Kentucky
Lexington, Kentucky 40536
RECRUITING
SCRI - Hematology Oncology Clinic - Baton Rouge
Baton Rouge, Louisiana 70809
RECRUITING
MaineHealth Cancer Care - Biddeford
Biddeford, Maine 04005
RECRUITING
Maryland Oncology Hematology - Columbia
Columbia, Maryland 21044
RECRUITING
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
RECRUITING
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
RECRUITING
Henry Ford Health System
Detroit, Michigan 48202
RECRUITING
USOR - Minnesota Oncology - Minneapolis Clinic
Minneapolis, Minnesota 55404
RECRUITING
Masonic Cancer Center
Minneapolis, Minnesota 55455
RECRUITING
Mayo Clinic - Rochester
Rochester, Minnesota 55905
RECRUITING
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota 55416
RECRUITING
Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
RECRUITING
Goldschmidt Cancer Center
Jefferson City, Missouri 65109
RECRUITING
Sisters of Charity of Leavenworth Health St. Marys
Billings, Montana 59102
RECRUITING
Methodist Estabrook Cancer Center
Omaha, Nebraska 68114
RECRUITING
University of Nebraska Medical Center
Omaha, Nebraska 68198
RECRUITING
USOR - Comprehensive Cancer Centers of Nevada - Southeast Henderson
Henderson, Nevada 89074
RECRUITING
New York Oncology Hematology - Albany Medical Center
Albany, New York 12206
RECRUITING
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203
RECRUITING
Local Institution - 001-832
Lake Success, New York 11042
WITHDRAWN
Perlmutter Cancer Center - 34th Street
New York, New York 10016
RECRUITING
Local Institution - 001-583
New York, New York 10032
WITHDRAWN
Memorial Sloan Kettering Cancer Center - New York
New York, New York 10065
RECRUITING
University of North Carolina Hospitals
Chapel Hill, North Carolina 27514
RECRUITING
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina 28374
RECRUITING
The Christ Hospital
Cincinnati, Ohio 45219
RECRUITING
University of Cincinnati Health Barrett Cancer Center
Cincinnati, Ohio 45267
RECRUITING
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio 44195
RECRUITING
The Ohio State University College of Medicine
Columbus, Ohio 43210
RECRUITING
SCRI - Mark H. Zangmeister Cancer Center
Columbus, Ohio 43219
RECRUITING
Kettering Health Cancer Center - Main Campus
Kettering, Ohio 45429
RECRUITING
Cancer Centers of Southwest Oklahoma - Leah M. Fitch Cancer Center
Lawton, Oklahoma 73505
RECRUITING
Local Institution - 001-580
Oklahoma City, Oklahoma 73142
WITHDRAWN
Oklahoma Cancer Specialists and Research Institute (OCSRI) - Tulsa
Tulsa, Oklahoma 74146
RECRUITING
St. Charles Health System
Bend, Oregon 97701
RECRUITING
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon 97401
RECRUITING
Lehigh Valley Physician Group Hematology Oncology
Allentown, Pennsylvania 18103
RECRUITING
Penn State Cancer Institute
Hershey, Pennsylvania 17033-0850
RECRUITING
USOR - Alliance Cancer Specialists - Media (Cancer Center at Riddle Memorial Hospital)
Media, Pennsylvania 19063
RECRUITING
USOR - Charleston Hematology Oncology Associates
Charleston, South Carolina 29414
RECRUITING
Medical University of South Carolina
Charleston, South Carolina 29425
RECRUITING
Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology
Nashville, Tennessee 37203
RECRUITING
USOR - Texas Oncology Dallas Fort Worth West (DFWW) - Arlington South
Arlington, Texas 76012
RECRUITING
USOR - Texas Oncology - Austin Central
Austin, Texas 78731
RECRUITING
Mary Crowley Cancer Research - Medical City Hospital
Dallas, Texas 75230
RECRUITING
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Presbyterian Cancer Center Dallas
Dallas, Texas 75231
RECRUITING
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
RECRUITING
USOR - Texas Oncology Northeast Texas - Denison
Denison, Texas 75020
RECRUITING
Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
Fort Worth, Texas 76104
RECRUITING
Oncology Consultants - Texas Medical Center
Houston, Texas 77030
RECRUITING
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
RECRUITING
Local Institution - 001-999
Irving, Texas 75063
NOT_YET_RECRUITING
Lumi Research
Kingwood, Texas 77339
RECRUITING
USOR - Texas Oncology - Midland Allison Cancer Center
Midland, Texas 79701
RECRUITING
START Center for Cancer Care
San Antonio, Texas 78229
RECRUITING
Texas Oncology - Sugar Land
Sugar Land, Texas 77479
RECRUITING
Texas Oncology - Northeast Texas Cancer and Research Institute - Tyler
Tyler, Texas 75702
RECRUITING
Texas Oncology - Waco
Waco, Texas 76712
RECRUITING
Local Institution - 001-919
Fairfax, Virginia 22031-4630
WITHDRAWN
NEXT Virginia
Fairfax, Virginia 22031
RECRUITING
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia 24408
RECRUITING
USOR - Virginia Oncology Associates - Newport News
Newport News, Virginia 23606
RECRUITING
Virginia Cancer Institute - West End
Richmond, Virginia 23229
RECRUITING
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
RECRUITING
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center
Vancouver, Washington 98684
RECRUITING
University Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
RECRUITING
Puerto Rico
PanOncology Trials - Rio Piedras Medical Center
San Juan 00935
RECRUITING

Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286 Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Inclusion Criteria

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; first-line treatment for NSCLC for certain cohorts
* Adequate organ function

Exclusion Criteria

Exclusion Criteria:

* History of intestinal disease or major gastric surgery or inability to swallow oral medications
* Other active cancer

NCT ID

NCT03785249

Date Trial Added

2018-12-24

Updated Date

2024-06-21