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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

Phase 1

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
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Local Institution - 001-807 Scottsdale, Arizona 85258	Withdrawn
Local Institution - 001-873-A Tucson, Arizona 85704	Not yet recruiting
USOR - Arizona Oncology - Tucson - Rudasill Tucson, Arizona 85704	Recruiting
Local Institution - 001-840-B Bellflower, California 90706	Not yet recruiting
Beverly Hills Cancer Center Beverly Hills, California 90211	Recruiting
City of Hope - Duarte (Main Campus) Duarte, California 91010	Recruiting
Local Institution - 001-850-K Dublin, California 94568	Not yet recruiting
Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton Fullerton, California 92835	Recruiting
Local Institution - 001-840-C Harbor City, California 90710	Not yet 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
Local Institution - 001-850-B Oakland, California 94611	Not yet recruiting
University of California Irvine Medical Center Orange, California 92868	Recruiting
Local Institution - 001-850-C Roseville, California 95661	Not yet recruiting
Local Institution - 001-850-J Sacramento, California 95814	Not yet recruiting
Local Institution - 001-850-D Sacramento, California 95825	Not yet recruiting
California Cancer Associates for Research and Excellence (cCARE) - San Diego 4S Ranch San Diego, California 92111	Recruiting
Local Institution - 001-840-A San Diego, California 92120	Not yet recruiting
Local Institution - 001-850-H San Francisco, California 94080	Not yet recruiting
Local Institution - 001-850-E San Francisco, California 94115	Not yet recruiting
Local Institution - 001-850-F San Jose, California 95119	Not yet recruiting
Local Institution - 001-850-A San Leandro, California 94577	Not yet recruiting
Ridley - Tree Cancer Center - Santa Barbara Santa Barbara, California 93105	Recruiting
Local Institution - 001-850-I Santa Clara, California 95051	Not yet recruiting
Local Institution - 001-884-A Solvang, California 93463	Not yet recruiting
Kaiser Permanente - Vallejo Medical Center Vallejo, California 94589	Recruiting
Local Institution - 001-850-G Walnut Creek, California 94596	Not yet recruiting
USOR - Rocky Mountain Cancer Centers - Aurora Aurora, Colorado 80012	Recruiting
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center Aurora, Colorado 80045	Recruiting
Local Institution - 001-872-H Boulder, Colorado 80303	Not yet recruiting
Local Institution - 001-872-E Colorado Springs, Colorado 80907	Not yet recruiting
Local Institution - 001-872-B Denver, Colorado 80218	Not yet recruiting
Local Institution - 001-951 - A Denver, Colorado 80218	Not yet recruiting
Local Institution - 001-951 - B Denver, Colorado 80218	Not yet 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
Local Institution - 001-872-A Lakewood, Colorado 80228	Not yet recruiting
Local Institution - 001-872-D Littleton, Colorado 80218	Not yet recruiting
Local Institution - 001-872-K Lone Tree, Colorado 80124	Not yet recruiting
Local Institution - 001-872-C Longmont, Colorado 80501	Not yet recruiting
Local Institution - 001-872-J Parker, Colorado 80138	Not yet recruiting
Local Institution - 001-872-F Pueblo, Colorado 81008	Not yet recruiting
Local Institution - 001-872-G Pueblo, Colorado 81008	Not yet recruiting
Local Institution - 001-872-I Thornton, Colorado 80260	Not yet recruiting
Yale Cancer Center New Haven, Connecticut 06510	Recruiting
USOR - Medical Oncology Hematology Consultants Newark, Delaware 19713-2055	Recruiting
Local Institution - 001-929i Altamonte Springs, Florida 32701	Not yet recruiting
Boca Raton Clinical Research Associates, Inc. Boca Raton, Florida 33432	Recruiting
Local Institution - 001-929c Brandon, Florida 33511	Not yet recruiting
Local Institution - 001-929g Clearwater, Florida 33761	Not yet recruiting
Local Institution - 001-926b Daytona Beach, Florida 32117	Not yet recruiting
SCRI - Florida Cancer Specialists - South Region Research Office Fort Myers, Florida 33901	Recruiting
Local Institution - 001-929b Gainesville, Florida 32605	Not yet recruiting
Mayo Clinic - Jacksonville Jacksonville, Florida 32224	Recruiting
Local Institution - 001-929m Lady Lake, Florida 32159	Not yet recruiting
Local Institution - 001-929e Largo, Florida 33770	Not yet recruiting
Local Institution - 001-929n Lecanto, Florida 34461	Not yet 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
Local Institution - 001-929p Ocala, Florida 34474	Not yet recruiting
Local Institution - 001-929j Orange City, Florida 32763	Not yet recruiting
Mid Florida Cancer Centers - Orange City Orange City, Florida 32763	Recruiting
Local Institution - 001-929l Orlando, Florida 32806	Not yet recruiting
Woodlands Medical Specialists Pensacola, Florida 32503	Recruiting
Local Institution - 001-929a Saint Petersburg, Florida 33705	Not yet recruiting
SCRI - Florida Cancer Specialists - North Region Research Office Saint Petersburg, Florida 33705	Recruiting
Local Institution - 001-929h Spring Hill, Florida 34608	Not yet recruiting
Local Institution - 001-926d Stuart, Florida 34994	Not yet recruiting
Local Institution - 001-929d Tampa, Florida 33607	Not yet recruiting
Local Institution - 001-929k Tavares, Florida 32778	Not yet recruiting
Local Institution - 001-929f Trinity, Florida 34655	Not yet recruiting
Local Institution - 001-926c Vero Beach, Florida 32960	Not yet recruiting
Local Institution - 001-926a Wellington, Florida 33414	Not yet recruiting
SCRI - Florida Cancer Specialists - East Region Research Office West Palm Beach, Florida 33401	Recruiting
Local Institution - 001-929o Winter Park, Florida 32789	Not yet recruiting
University Cancer & Blood Center (UCBC) - Athens Athens, Georgia 30607	Recruiting
Local Institution - 001-835-C Austell, Georgia 30106	Not yet recruiting
Local Institution - 001-835-E Austell, Georgia 30106	Not yet recruiting
Local Institution - 001-835-D Carrollton, Georgia 30117	Not yet recruiting
Local Institution - 001-835-F Carrollton, Georgia 30117	Not yet recruiting
Local Institution - 001-835-A Cartersville, Georgia 30121	Not yet recruiting
Local Institution - 001-835-B Douglasville, Georgia 30134	Not yet 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
University of Iowa Iowa City, Iowa 52242	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
Local Institution - 001-881-B Brandywine, Maryland 20613	Not yet recruiting
Maryland Oncology Hematology - Columbia Columbia, Maryland 21044	Recruiting
Local Institution - 001-881-A Silver Spring, Maryland 20904	Not yet 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
Local Institution - 001-842-A Farmington Hills, Michigan 48334	Not yet recruiting
Local Institution - 001-838-F Coon Rapids, Minnesota 55433	Not yet recruiting
Local Institution - 001-838-E Edina, Minnesota 55435	Not yet recruiting
Local Institution - 001-875 - D Edina, Minnesota 55435	Not yet recruiting
Local Institution - 001-838-D Maplewood, Minnesota 55109	Not yet recruiting
Local Institution - 001-875 - A Maplewood, Minnesota 55109	Not yet recruiting
Local Institution - 001-838-C Minneapolis, Minnesota 55404	Not yet recruiting
USOR - Minnesota Oncology - Minneapolis Clinic Minneapolis, Minnesota 55404	Recruiting
Local Institution - 001-838-G Minneapolis, Minnesota 55415	Not yet recruiting
Local Institution - 001-822-A Minneapolis, Minnesota 55455	Not yet 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
Local Institution - 001-838-B Saint Louis Park, Minnesota 55426-5000	Not yet recruiting
Local Institution - 001-838-A Saint Paul, Minnesota 55101	Not yet recruiting
Local Institution - 001-875 - B Saint Paul, Minnesota 55102	Not yet recruiting
Local Institution - 001-875 - C Woodbury, Minnesota 55125	Not yet 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
Local Institution - 001-544B Omaha, Nebraska 68105-1850	Not yet recruiting
Methodist Estabrook Cancer Center Omaha, Nebraska 68114	Recruiting
Local Institution - 001-544A Omaha, Nebraska 68118	Not yet recruiting
University of Nebraska Medical Center Omaha, Nebraska 68198	Recruiting
Local Institution - 001-860A Henderson, Nevada 89052	Not yet recruiting
Local Institution - 001-860C Henderson, Nevada 89052	Not yet recruiting
Local Institution - 001-860B Henderson, Nevada 89074	Not yet recruiting
USOR - Comprehensive Cancer Centers of Nevada - Southeast Henderson Henderson, Nevada 89074	Recruiting
Local Institution - 001-860E Las Vegas, Nevada 89128	Not yet recruiting
Local Institution - 001-860D Las Vegas, Nevada 89144	Not yet recruiting
Local Institution - 001-860F Las Vegas, Nevada 89148	Not yet 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
Local Institution - 001-833 - H Columbus, Ohio 43201	Not yet recruiting
Local Institution - 001-833 - C Columbus, Ohio 43203	Not yet recruiting
Local Institution - 001-833 - J Columbus, Ohio 43203	Not yet recruiting
Local Institution - 001-833 - A Columbus, Ohio 43210	Not yet recruiting
Local Institution - 001-833 - F Columbus, Ohio 43210	Not yet recruiting
The Ohio State University College of Medicine Columbus, Ohio 43210	Recruiting
Local Institution - 001-833 - D Columbus, Ohio 43212	Not yet recruiting
Local Institution - 001-833 - I Columbus, Ohio 43212	Not yet recruiting
SCRI - Mark H. Zangmeister Cancer Center Columbus, Ohio 43219	Recruiting
Local Institution - 001-833 - B Columbus, Ohio 43221	Not yet recruiting
Local Institution - 001-833 - G Columbus, Ohio 43221	Not yet recruiting
Local Institution - 001-833 - E Gahanna, Ohio 43230	Not yet recruiting
Kettering Health Cancer Center - Main Campus Kettering, Ohio 45429	Recruiting
Local Institution - 001-836-A Kettering, Ohio 45429	Not yet recruiting
Cancer Centers of Southwest Oklahoma - Leah M. Fitch Cancer Center Lawton, Oklahoma 73505	Recruiting
Local Institution - 001-580 Oklahoma City, Oklahoma 73142	Withdrawn
Local Institution - 001-584 Tulsa, Oklahoma 74146	Completed
Local Institution - 001-586-A Bend, Oregon 97701	Not yet 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
Local Institution - 001-837-A Bethlehem, Pennsylvania 18017	Not yet 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
Local Institution - 001-801-G Gallatin, Tennessee 37066	Not yet recruiting
Local Institution - 001-801-A Hendersonville, Tennessee 37075	Not yet recruiting
Local Institution - 001-801-D Hermitage, Tennessee 37076	Not yet recruiting
Local Institution - 001-801-F Murfreesboro, Tennessee 37129	Not yet recruiting
Local Institution - 001-801-B Nashville, Tennessee 37203	Not yet recruiting
Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology Nashville, Tennessee 37203	Recruiting
Local Institution - 001-801-E Nashville, Tennessee 37207	Not yet recruiting
Local Institution - 001-801-C Nashville, Tennessee 37211	Not yet recruiting
Local Institution - 001-888-B Arlington, Texas 76012	Not yet recruiting
USOR - Texas Oncology Dallas Fort Worth West (DFWW) - Arlington South Arlington, Texas 76012	Recruiting
USOR - Texas Oncology - Austin Central Austin, Texas 78731	Recruiting
Local Institution - 001-848a Conroe, Texas 77384	Not yet 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 - 001-935A Houston, Texas 77090	Not yet recruiting
Local Institution - 001-999 Irving, Texas 75063	Not yet recruiting
Local Institution - 001-935D Kingwood, Texas 77339	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
Local Institution - 001-935B Shenandoah, Texas 77380	Not yet recruiting
Local Institution - 001-935C Spring, Texas 77389	Not yet recruiting
Texas Oncology - Sugar Land Sugar Land, Texas 77479	Recruiting
Local Institution - 001-935E Tomball, Texas 77375	Not yet 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
Local Institution - 001-882-A Norfolk, Virginia 23502	Not yet 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

2024-09-20