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

Program Status

Active, not recruiting

Phase

Phase 1 Phase 2

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)”.

Helpful Links

https://www.annalsofoncology.org/article/S0923-7534(22)03898-4/fulltext

Location	Location Status
United States
Local Institution - 001-826 Birmingham, Alabama 35294	Active, not recruiting
Local Institution - 001-965 Anchorage, Alaska 99508	Active, not recruiting
Local Institution - 001-821 Phoenix, Arizona 85054	Active, not recruiting
Local Institution - 001-873-A Tucson, Arizona 85704	Active, not recruiting
Local Institution - 001-873 Tucson, Arizona 85704	Active, not recruiting
Local Institution - 001-840-B Bellflower, California 90706	Active, not recruiting
Local Institution - 001-834 Beverly Hills, California 90211	Active, not recruiting
Local Institution - 001-843 Duarte, California 91010	Active, not recruiting
Local Institution - 001-850-K Dublin, California 94568	Active, not recruiting
Local Institution - 001-851 Fullerton, California 92835	Active, not recruiting
Local Institution - 001-840-C Harbor City, California 90710	Active, not recruiting
Local Institution - 001-805 La Jolla, California 92093	Active, not recruiting
Local Institution - 001-779 Los Alamitos, California 90720	Active, not recruiting
Local Institution - 001-840 Los Angeles, California 90027	Active, not recruiting
Local Institution - 001-578 Los Angeles, California 90067	Active, not recruiting
Local Institution - 001-847 Newport Beach, California 92663	Active, not recruiting
Local Institution - 001-850-B Oakland, California 94611	Active, not recruiting
Local Institution - 001-803 Orange, California 92868	Active, not recruiting
Local Institution - 001-850-C Roseville, California 95661	Active, not recruiting
Local Institution - 001-850-J Sacramento, California 95814	Active, not recruiting
Local Institution - 001-850-D Sacramento, California 95825	Active, not recruiting
Local Institution - 001-845 San Diego, California 92111	Active, not recruiting
Local Institution - 001-840-A San Diego, California 92120	Active, not recruiting
Local Institution - 001-850-H San Francisco, California 94080	Active, not recruiting
Local Institution - 001-850-E San Francisco, California 94115	Active, not recruiting
Local Institution - 001-850-F San Jose, California 95119	Active, not recruiting
Local Institution - 001-850-A San Leandro, California 94577	Active, not recruiting
Local Institution - 001-884 Santa Barbara, California 93105	Active, not recruiting
Local Institution - 001-850-I Santa Clara, California 95051	Active, not recruiting
Local Institution - 001-884-A Solvang, California 93463	Active, not recruiting
Local Institution - 001-850 Vallejo, California 94589	Active, not recruiting
Local Institution - 001-850-G Walnut Creek, California 94596	Active, not recruiting
Local Institution - 001-872 Aurora, Colorado 80012	Active, not recruiting
Local Institution - 001-810 Aurora, Colorado 80045	Active, not recruiting
Local Institution - 001-872-H Boulder, Colorado 80303	Active, not recruiting
Local Institution - 001-872-E Colorado Springs, Colorado 80907	Active, not recruiting
Local Institution - 001-872-L Colorado Springs, Colorado 80920	Active, not recruiting
Local Institution - 001-872-B Denver, Colorado 80218	Active, not recruiting
Local Institution - 001-951 - A Denver, Colorado 80218	Active, not recruiting
Local Institution - 001-951 - B Denver, Colorado 80218	Active, not recruiting
Local Institution - 001-846 Grand Junction, Colorado 81501	Active, not recruiting
Local Institution - 001-951 Lafayette, Colorado 80026	Active, not recruiting
Local Institution - 001-872-A Lakewood, Colorado 80228	Active, not recruiting
Local Institution - 001-872-D Littleton, Colorado 80218	Active, not recruiting
Local Institution - 001-872-K Lone Tree, Colorado 80124	Active, not recruiting
Local Institution - 001-872-C Longmont, Colorado 80501	Active, not recruiting
Local Institution - 001-872-J Parker, Colorado 80138	Active, not recruiting
Local Institution - 001-872-F Pueblo, Colorado 81008	Active, not recruiting
Local Institution - 001-872-G Pueblo, Colorado 81008	Active, not recruiting
Local Institution - 001-872-I Thornton, Colorado 80260	Active, not recruiting
Local Institution - 001-816 New Haven, Connecticut 06510	Active, not recruiting
Local Institution - 001-871 Newark, Delaware 19713-2055	Active, not recruiting
Local Institution - 001-929i Altamonte Springs, Florida 32701	Active, not recruiting
Local Institution - 001-839 Boca Raton, Florida 33432	Active, not recruiting
Local Institution - 001-922A Bonita Springs, Florida 34135	Active, not recruiting
Local Institution - 001-922D Bradenton, Florida 34211	Active, not recruiting
Local Institution - 001-929c Brandon, Florida 33511	Active, not recruiting
Local Institution - 001-922E Cape Coral, Florida 33909	Active, not recruiting
Local Institution - 001-929g Clearwater, Florida 33761	Active, not recruiting
Local Institution - 001-926b Daytona Beach, Florida 32117	Active, not recruiting
Local Institution - 001-922 Fort Myers, Florida 33901	Active, not recruiting
Local Institution - 001-922B Fort Myers, Florida 33905	Active, not recruiting
Local Institution - 001-922C Fort Myers, Florida 33908	Active, not recruiting
Local Institution - 001-929b Gainesville, Florida 32605	Active, not recruiting
Local Institution - 001-829 Jacksonville, Florida 32224	Active, not recruiting
Local Institution - 001-929m Lady Lake, Florida 32159	Active, not recruiting
Local Institution - 001-929e Largo, Florida 33770	Active, not recruiting
Local Institution - 001-929n Lecanto, Florida 34461	Active, not recruiting
Local Institution - 001-870 Miami, Florida 33176	Active, not recruiting
Local Institution - 001-825 Miami Beach, Florida 33140	Active, not recruiting
Local Institution - 001-922F Naples, Florida 34102	Active, not recruiting
Local Institution - 001-922G Naples, Florida 34102	Active, not recruiting
Local Institution - 001-538 Ocala, Florida 34474	Active, not recruiting
Local Institution - 001-929p Ocala, Florida 34474	Active, not recruiting
Local Institution - 001-914 Orange City, Florida 32763	Active, not recruiting
Local Institution - 001-929j Orange City, Florida 32763	Active, not recruiting
Local Institution - 001-929l Orlando, Florida 32806	Active, not recruiting
Local Institution - 001-877 Pensacola, Florida 32503	Active, not recruiting
Local Institution - 001-922H Port Charlotte, Florida 33980	Active, not recruiting
Local Institution - 001-922I Sarasota, Florida 34232	Active, not recruiting
Local Institution - 001-922J Sarasota, Florida 34236	Active, not recruiting
Local Institution - 001-929h Spring Hill, Florida 34608	Active, not recruiting
Local Institution - 001-929a St. Petersburg, Florida 33705	Active, not recruiting
Local Institution - 001-929 St. Petersburg, Florida 33705	Active, not recruiting
Local Institution - 001-926d Stuart, Florida 34994	Active, not recruiting
Local Institution - 001-929d Tampa, Florida 33607	Active, not recruiting
Local Institution - 001-929k Tavares, Florida 32778	Active, not recruiting
Local Institution - 001-929f Trinity, Florida 34655	Active, not recruiting
Local Institution - 001-922K Venice, Florida 34285	Active, not recruiting
Local Institution - 001-922L Venice, Florida 34292	Active, not recruiting
Local Institution - 001-926c Vero Beach, Florida 32960	Active, not recruiting
Local Institution - 001-926a Wellington, Florida 33414	Active, not recruiting
Local Institution - 001-926 West Palm Beach, Florida 33401	Active, not recruiting
Local Institution - 001-929o Winter Park, Florida 32789	Active, not recruiting
Local Institution - 001-967 Athens, Georgia 30607	Active, not recruiting
Local Institution - 001-835-C Austell, Georgia 30106	Active, not recruiting
Local Institution - 001-835-E Austell, Georgia 30106	Active, not recruiting
Local Institution - 001-835-D Carrollton, Georgia 30117	Active, not recruiting
Local Institution - 001-835-F Carrollton, Georgia 30117	Active, not recruiting
Local Institution - 001-835-A Cartersville, Georgia 30121	Active, not recruiting
Local Institution - 001-835-B Douglasville, Georgia 30134	Active, not recruiting
Local Institution - 001-835 Marietta, Georgia 30060	Active, not recruiting
Local Institution - 001-862 Chicago Ridge, Illinois 60415	Active, not recruiting
Local Institution - 001-883 Niles, Illinois 60714	Active, not recruiting
Local Institution - 001-781 South Bend, Indiana 46601	Active, not recruiting
Local Institution - 001-831 Iowa City, Iowa 52242	Active, not recruiting
Local Institution - 001-820 Westwood, Kansas 66205	Active, not recruiting
Local Institution - 001-844 Lexington, Kentucky 40536	Active, not recruiting
Local Institution - 001-920 Baton Rouge, Louisiana 70809	Active, not recruiting
Local Institution - 001-827 Biddeford, Maine 04005	Active, not recruiting
Local Institution - 001-881-B Brandywine, Maryland 20613	Active, not recruiting
Local Institution - 001-881 Columbia, Maryland 21044	Active, not recruiting
Local Institution - 001-881-A Silver Spring, Maryland 20904	Active, not recruiting
Local Institution - 001-808 Boston, Massachusetts 02215	Active, not recruiting
Local Institution - 001-842 Detroit, Michigan 48201	Active, not recruiting
Local Institution - 001-811 Detroit, Michigan 48202	Active, not recruiting
Local Institution - 001-842-A Farmington Hills, Michigan 48334	Active, not recruiting
Local Institution - 001-838-F Coon Rapids, Minnesota 55433	Active, not recruiting
Local Institution - 001-838-E Edina, Minnesota 55435	Active, not recruiting
Local Institution - 001-875 - D Edina, Minnesota 55435	Active, not recruiting
Local Institution - 001-838-D Maplewood, Minnesota 55109	Active, not recruiting
Local Institution - 001-875 - A Maplewood, Minnesota 55109	Active, not recruiting
Local Institution - 001-838-C Minneapolis, Minnesota 55404	Active, not recruiting
Local Institution - 001-875 Minneapolis, Minnesota 55404	Active, not recruiting
Local Institution - 001-838-G Minneapolis, Minnesota 55415	Active, not recruiting
Local Institution - 001-822-A Minneapolis, Minnesota 55455	Active, not recruiting
Local Institution - 001-822 Minneapolis, Minnesota 55455	Active, not recruiting
Local Institution - 001-830 Rochester, Minnesota 55905	Active, not recruiting
Local Institution - 001-838 Saint Louis Park, Minnesota 55416	Active, not recruiting
Local Institution - 001-838-B Saint Louis Park, Minnesota 55426-5000	Active, not recruiting
Local Institution - 001-838-A Saint Paul, Minnesota 55101	Active, not recruiting
Local Institution - 001-875 - B Saint Paul, Minnesota 55102	Active, not recruiting
Local Institution - 001-875 - C Woodbury, Minnesota 55125	Active, not recruiting
Local Institution - 001-952 Bolivar, Missouri 65613	Active, not recruiting
Local Institution - 001-950 Jefferson City, Missouri 65109	Active, not recruiting
Local Institution - 001-841 Billings, Montana 59102	Active, not recruiting
Local Institution - 001-544B Omaha, Nebraska 68105-1850	Active, not recruiting
Local Institution - 001-959 Omaha, Nebraska 68114	Active, not recruiting
Local Institution - 001-544A Omaha, Nebraska 68118	Active, not recruiting
Local Institution - 001-544 Omaha, Nebraska 68198	Active, not recruiting
Local Institution - 001-860A Henderson, Nevada 89052	Active, not recruiting
Local Institution - 001-860C Henderson, Nevada 89052	Active, not recruiting
Local Institution - 001-860B Henderson, Nevada 89074	Active, not recruiting
Local Institution - 001-860 Henderson, Nevada 89074	Active, not recruiting
Local Institution - 001-860E Las Vegas, Nevada 89128	Active, not recruiting
Local Institution - 001-860D Las Vegas, Nevada 89144	Active, not recruiting
Local Institution - 001-860F Las Vegas, Nevada 89148	Active, not recruiting
Local Institution - 001-861 Albany, New York 12206	Active, not recruiting
Local Institution - 001-815 Buffalo, New York 14203	Active, not recruiting
Local Institution - 001-813 New York, New York 10016	Active, not recruiting
Local Institution - 001-806 New York, New York 10065	Active, not recruiting
Local Institution - 001-812 Chapel Hill, North Carolina 27514	Active, not recruiting
Local Institution - 001-971 Pinehurst, North Carolina 28374	Active, not recruiting
Local Institution - 001-966 Cincinnati, Ohio 45219	Active, not recruiting
Local Institution - 001-823 Cincinnati, Ohio 45267	Active, not recruiting
Local Institution - 001-818 Cleveland, Ohio 44195	Active, not recruiting
Local Institution - 001-833 - H Columbus, Ohio 43201	Active, not recruiting
Local Institution - 001-833 - C Columbus, Ohio 43203	Active, not recruiting
Local Institution - 001-833 - J Columbus, Ohio 43203	Active, not recruiting
Local Institution - 001-833 - A Columbus, Ohio 43210	Active, not recruiting
Local Institution - 001-833 - F Columbus, Ohio 43210	Active, not recruiting
Local Institution - 001-833 Columbus, Ohio 43210	Active, not recruiting
Local Institution - 001-833 - D Columbus, Ohio 43212	Active, not recruiting
Local Institution - 001-833 - I Columbus, Ohio 43212	Active, not recruiting
Local Institution - 001-930 Columbus, Ohio 43219	Active, not recruiting
Local Institution - 001-833 - B Columbus, Ohio 43221	Active, not recruiting
Local Institution - 001-833 - G Columbus, Ohio 43221	Active, not recruiting
Local Institution - 001-833 - E Gahanna, Ohio 43230	Active, not recruiting
Local Institution - 001-836-A Kettering, Ohio 45429	Active, not recruiting
Local Institution - 001-836 Kettering, Ohio 45429	Active, not recruiting
Local Institution - 001-600 Lawton, Oklahoma 73505	Active, not recruiting
Local Institution - 001-584 Tulsa, Oklahoma 74146	Active, not recruiting
Local Institution - 001-586-A Bend, Oregon 97701	Active, not recruiting
Local Institution - 001-586 Bend, Oregon 97701	Active, not recruiting
Local Institution - 001-889 Eugene, Oregon 97401	Active, not recruiting
Local Institution - 001-837 Allentown, Pennsylvania 18103	Active, not recruiting
Local Institution - 001-837-A Bethlehem, Pennsylvania 18017	Active, not recruiting
Local Institution - 001-817 Hershey, Pennsylvania 17033-0850	Active, not recruiting
Local Institution - 001-783 Media, Pennsylvania 19063	Active, not recruiting
Local Institution - 001-887 Charleston, South Carolina 29414	Active, not recruiting
Local Institution - 001-819 Charleston, South Carolina 29425	Active, not recruiting
Local Institution - 001-801-G Gallatin, Tennessee 37066	Active, not recruiting
Local Institution - 001-801-A Hendersonville, Tennessee 37075	Active, not recruiting
Local Institution - 001-801-D Hermitage, Tennessee 37076	Active, not recruiting
Local Institution - 001-801-F Murfreesboro, Tennessee 37129	Active, not recruiting
Local Institution - 001-801-B Nashville, Tennessee 37203	Active, not recruiting
Local Institution - 001-801 Nashville, Tennessee 37203	Active, not recruiting
Local Institution - 001-801-E Nashville, Tennessee 37207	Active, not recruiting
Local Institution - 001-801-C Nashville, Tennessee 37211	Active, not recruiting
Local Institution - 001-888-B Arlington, Texas 76012	Active, not recruiting
Local Institution - 001-888 Arlington, Texas 76012	Active, not recruiting
Local Institution - 001-880 Austin, Texas 78731	Active, not recruiting
Local Institution - 001-848a Conroe, Texas 77384	Active, not recruiting
Local Institution - 001-809 Dallas, Texas 75230	Active, not recruiting
Local Institution - 001-886 Dallas, Texas 75231	Active, not recruiting
Local Institution - 001-879 Dallas, Texas 75246	Active, not recruiting
Local Institution - 001-785 Denison, Texas 75020	Active, not recruiting
Local Institution - 001-876 Fort Worth, Texas 76104	Active, not recruiting
Local Institution - 001-848 Houston, Texas 77030	Active, not recruiting
Local Institution - 001-969 Houston, Texas 77030	Active, not recruiting
Local Institution - 001-935A Houston, Texas 77090	Active, not recruiting
Local Institution - 001-999 Irving, Texas 75063	Active, not recruiting
Local Institution - 001-935D Kingwood, Texas 77339	Active, not recruiting
Local Institution - 001-935 Kingwood, Texas 77339	Active, not recruiting
Local Institution - 001-554 Midland, Texas 79701	Active, not recruiting
Local Institution - 001-802 San Antonio, Texas 78229	Active, not recruiting
Local Institution - 001-935B Shenandoah, Texas 77380	Active, not recruiting
Local Institution - 001-935C Spring, Texas 77389	Active, not recruiting
Local Institution - 001-874 Sugar Land, Texas 77479	Active, not recruiting
Local Institution - 001-935E Tomball, Texas 77375	Active, not recruiting
Local Institution - 001-878 Tyler, Texas 75702	Active, not recruiting
Local Institution - 001-890 Waco, Texas 76712	Active, not recruiting
Local Institution - 001-814 Fairfax, Virginia 22031	Active, not recruiting
Local Institution - 001-597 Fredericksburg, Virginia 24408	Active, not recruiting
Local Institution - 001-882 Newport News, Virginia 23606	Active, not recruiting
Local Institution - 001-882-A Norfolk, Virginia 23502	Active, not recruiting
Local Institution - 001-890-A Norfolk, Virginia 23502	Active, not recruiting
Local Institution - 001-968 Richmond, Virginia 23229	Active, not recruiting
Local Institution - 001-824 Seattle, Washington 98109	Active, not recruiting
Local Institution - 001-885 Vancouver, Washington 98684	Active, not recruiting
Local Institution - 001-804 Madison, Wisconsin 53792	Active, not recruiting
Puerto Rico
Local Institution - 001-900 San Juan, PR 00935	Active, not recruiting

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

2025-09-30