Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
NCT ID: NCT03785249
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
731 participants
INTERVENTIONAL
2019-01-15
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1 Dose Exploration
Dose escalation of MRTX849 to determine maximum tolerated dose
MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Phase 1b Expansion
Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens
MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Phase 2
Separate cohorts of patients stratified by histological diagnosis, prior treatment history or co-mutation status (e.g., STK11) for evaluation of clinical activity of MRTX849
MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Pilot Phase 1b Combination with Pembrolizumab
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with pembrolizumab in patients with NSCLC
MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Pembrolizumab
Pembrolizumab is administered as an intravenous infusion once every 3 weeks
Pilot Phase 1b Combination with Cetuximab
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with CRC
MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Cetuximab
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
Pilot Phase 1b Combination with Afatinib
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC
MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Afatinib
Afatinib will be administered orally once a day in a continuous regimen
Phase 2 Combination with Cetuximab
Phase 2 evaluation of the clinical activity of MRTX849 in combination with cetuximab in patients with CRC
MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Cetuximab
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
Pilot Phase 1b Combination with Cetuximab in NSCLC
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with NSCLC
MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Cetuximab
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
Pilot Phase 1b Combination with Cetuximab in PDAC
Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with pancreatic adenocarcinoma (PDAC)
MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Cetuximab
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
Interventions
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MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Pembrolizumab
Pembrolizumab is administered as an intravenous infusion once every 3 weeks
Cetuximab
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
Afatinib
Afatinib will be administered orally once a day in a continuous regimen
Eligibility Criteria
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Inclusion Criteria
* 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
* Other active cancer
18 Years
ALL
No
Sponsors
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Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 001-826
Birmingham, Alabama, United States
Local Institution - 001-965
Anchorage, Alaska, United States
Local Institution - 001-821
Phoenix, Arizona, United States
Local Institution - 001-873-A
Tucson, Arizona, United States
Local Institution - 001-873
Tucson, Arizona, United States
Local Institution - 001-840-B
Bellflower, California, United States
Local Institution - 001-834
Beverly Hills, California, United States
Local Institution - 001-843
Duarte, California, United States
Local Institution - 001-850-K
Dublin, California, United States
Local Institution - 001-851
Fullerton, California, United States
Local Institution - 001-840-C
Harbor City, California, United States
Local Institution - 001-805
La Jolla, California, United States
Local Institution - 001-779
Los Alamitos, California, United States
Local Institution - 001-840
Los Angeles, California, United States
Local Institution - 001-578
Los Angeles, California, United States
Local Institution - 001-847
Newport Beach, California, United States
Local Institution - 001-850-B
Oakland, California, United States
Local Institution - 001-803
Orange, California, United States
Local Institution - 001-850-C
Roseville, California, United States
Local Institution - 001-850-J
Sacramento, California, United States
Local Institution - 001-850-D
Sacramento, California, United States
Local Institution - 001-845
San Diego, California, United States
Local Institution - 001-840-A
San Diego, California, United States
Local Institution - 001-850-H
San Francisco, California, United States
Local Institution - 001-850-E
San Francisco, California, United States
Local Institution - 001-850-F
San Jose, California, United States
Local Institution - 001-850-A
San Leandro, California, United States
Local Institution - 001-884
Santa Barbara, California, United States
Local Institution - 001-850-I
Santa Clara, California, United States
Local Institution - 001-884-A
Solvang, California, United States
Local Institution - 001-850
Vallejo, California, United States
Local Institution - 001-850-G
Walnut Creek, California, United States
Local Institution - 001-872
Aurora, Colorado, United States
Local Institution - 001-810
Aurora, Colorado, United States
Local Institution - 001-872-H
Boulder, Colorado, United States
Local Institution - 001-872-E
Colorado Springs, Colorado, United States
Local Institution - 001-872-L
Colorado Springs, Colorado, United States
Local Institution - 001-872-B
Denver, Colorado, United States
Local Institution - 001-951 - A
Denver, Colorado, United States
Local Institution - 001-951 - B
Denver, Colorado, United States
Local Institution - 001-846
Grand Junction, Colorado, United States
Local Institution - 001-951
Lafayette, Colorado, United States
Local Institution - 001-872-A
Lakewood, Colorado, United States
Local Institution - 001-872-D
Littleton, Colorado, United States
Local Institution - 001-872-K
Lone Tree, Colorado, United States
Local Institution - 001-872-C
Longmont, Colorado, United States
Local Institution - 001-872-J
Parker, Colorado, United States
Local Institution - 001-872-F
Pueblo, Colorado, United States
Local Institution - 001-872-G
Pueblo, Colorado, United States
Local Institution - 001-872-I
Thornton, Colorado, United States
Local Institution - 001-816
New Haven, Connecticut, United States
Local Institution - 001-871
Newark, Delaware, United States
Local Institution - 001-929i
Altamonte Springs, Florida, United States
Local Institution - 001-839
Boca Raton, Florida, United States
Local Institution - 001-922A
Bonita Springs, Florida, United States
Local Institution - 001-922D
Bradenton, Florida, United States
Local Institution - 001-929c
Brandon, Florida, United States
Local Institution - 001-922E
Cape Coral, Florida, United States
Local Institution - 001-929g
Clearwater, Florida, United States
Local Institution - 001-926b
Daytona Beach, Florida, United States
Local Institution - 001-922
Fort Myers, Florida, United States
Local Institution - 001-922B
Fort Myers, Florida, United States
Local Institution - 001-922C
Fort Myers, Florida, United States
Local Institution - 001-929b
Gainesville, Florida, United States
Local Institution - 001-829
Jacksonville, Florida, United States
Local Institution - 001-929m
Lady Lake, Florida, United States
Local Institution - 001-929e
Largo, Florida, United States
Local Institution - 001-929n
Lecanto, Florida, United States
Local Institution - 001-870
Miami, Florida, United States
Local Institution - 001-825
Miami Beach, Florida, United States
Local Institution - 001-922F
Naples, Florida, United States
Local Institution - 001-922G
Naples, Florida, United States
Local Institution - 001-538
Ocala, Florida, United States
Local Institution - 001-929p
Ocala, Florida, United States
Local Institution - 001-914
Orange City, Florida, United States
Local Institution - 001-929j
Orange City, Florida, United States
Local Institution - 001-929l
Orlando, Florida, United States
Local Institution - 001-877
Pensacola, Florida, United States
Local Institution - 001-922H
Port Charlotte, Florida, United States
Local Institution - 001-922I
Sarasota, Florida, United States
Local Institution - 001-922J
Sarasota, Florida, United States
Local Institution - 001-929h
Spring Hill, Florida, United States
Local Institution - 001-929a
St. Petersburg, Florida, United States
Local Institution - 001-929
St. Petersburg, Florida, United States
Local Institution - 001-926d
Stuart, Florida, United States
Local Institution - 001-929d
Tampa, Florida, United States
Local Institution - 001-929k
Tavares, Florida, United States
Local Institution - 001-929f
Trinity, Florida, United States
Local Institution - 001-922K
Venice, Florida, United States
Local Institution - 001-922L
Venice, Florida, United States
Local Institution - 001-926c
Vero Beach, Florida, United States
Local Institution - 001-926a
Wellington, Florida, United States
Local Institution - 001-926
West Palm Beach, Florida, United States
Local Institution - 001-929o
Winter Park, Florida, United States
Local Institution - 001-967
Athens, Georgia, United States
Local Institution - 001-835-C
Austell, Georgia, United States
Local Institution - 001-835-E
Austell, Georgia, United States
Local Institution - 001-835-D
Carrollton, Georgia, United States
Local Institution - 001-835-F
Carrollton, Georgia, United States
Local Institution - 001-835-A
Cartersville, Georgia, United States
Local Institution - 001-835-B
Douglasville, Georgia, United States
Local Institution - 001-835
Marietta, Georgia, United States
Local Institution - 001-862
Chicago Ridge, Illinois, United States
Local Institution - 001-883
Niles, Illinois, United States
Local Institution - 001-781
South Bend, Indiana, United States
Local Institution - 001-831
Iowa City, Iowa, United States
Local Institution - 001-820
Westwood, Kansas, United States
Local Institution - 001-844
Lexington, Kentucky, United States
Local Institution - 001-920
Baton Rouge, Louisiana, United States
Local Institution - 001-827
Biddeford, Maine, United States
Local Institution - 001-881-B
Brandywine, Maryland, United States
Local Institution - 001-881
Columbia, Maryland, United States
Local Institution - 001-881-A
Silver Spring, Maryland, United States
Local Institution - 001-808
Boston, Massachusetts, United States
Local Institution - 001-842
Detroit, Michigan, United States
Local Institution - 001-811
Detroit, Michigan, United States
Local Institution - 001-842-A
Farmington Hills, Michigan, United States
Local Institution - 001-838-F
Coon Rapids, Minnesota, United States
Local Institution - 001-838-E
Edina, Minnesota, United States
Local Institution - 001-875 - D
Edina, Minnesota, United States
Local Institution - 001-838-D
Maplewood, Minnesota, United States
Local Institution - 001-875 - A
Maplewood, Minnesota, United States
Local Institution - 001-838-C
Minneapolis, Minnesota, United States
Local Institution - 001-875
Minneapolis, Minnesota, United States
Local Institution - 001-838-G
Minneapolis, Minnesota, United States
Local Institution - 001-822-A
Minneapolis, Minnesota, United States
Local Institution - 001-822
Minneapolis, Minnesota, United States
Local Institution - 001-830
Rochester, Minnesota, United States
Local Institution - 001-838
Saint Louis Park, Minnesota, United States
Local Institution - 001-838-B
Saint Louis Park, Minnesota, United States
Local Institution - 001-838-A
Saint Paul, Minnesota, United States
Local Institution - 001-875 - B
Saint Paul, Minnesota, United States
Local Institution - 001-875 - C
Woodbury, Minnesota, United States
Local Institution - 001-952
Bolivar, Missouri, United States
Local Institution - 001-950
Jefferson City, Missouri, United States
Local Institution - 001-841
Billings, Montana, United States
Local Institution - 001-544B
Omaha, Nebraska, United States
Local Institution - 001-959
Omaha, Nebraska, United States
Local Institution - 001-544A
Omaha, Nebraska, United States
Local Institution - 001-544
Omaha, Nebraska, United States
Local Institution - 001-860A
Henderson, Nevada, United States
Local Institution - 001-860C
Henderson, Nevada, United States
Local Institution - 001-860B
Henderson, Nevada, United States
Local Institution - 001-860
Henderson, Nevada, United States
Local Institution - 001-860E
Las Vegas, Nevada, United States
Local Institution - 001-860D
Las Vegas, Nevada, United States
Local Institution - 001-860F
Las Vegas, Nevada, United States
Local Institution - 001-861
Albany, New York, United States
Local Institution - 001-815
Buffalo, New York, United States
Local Institution - 001-813
New York, New York, United States
Local Institution - 001-806
New York, New York, United States
Local Institution - 001-812
Chapel Hill, North Carolina, United States
Local Institution - 001-971
Pinehurst, North Carolina, United States
Local Institution - 001-966
Cincinnati, Ohio, United States
Local Institution - 001-823
Cincinnati, Ohio, United States
Local Institution - 001-818
Cleveland, Ohio, United States
Local Institution - 001-833 - H
Columbus, Ohio, United States
Local Institution - 001-833 - C
Columbus, Ohio, United States
Local Institution - 001-833 - J
Columbus, Ohio, United States
Local Institution - 001-833 - A
Columbus, Ohio, United States
Local Institution - 001-833 - F
Columbus, Ohio, United States
Local Institution - 001-833
Columbus, Ohio, United States
Local Institution - 001-833 - D
Columbus, Ohio, United States
Local Institution - 001-833 - I
Columbus, Ohio, United States
Local Institution - 001-930
Columbus, Ohio, United States
Local Institution - 001-833 - B
Columbus, Ohio, United States
Local Institution - 001-833 - G
Columbus, Ohio, United States
Local Institution - 001-833 - E
Gahanna, Ohio, United States
Local Institution - 001-836-A
Kettering, Ohio, United States
Local Institution - 001-836
Kettering, Ohio, United States
Local Institution - 001-600
Lawton, Oklahoma, United States
Local Institution - 001-584
Tulsa, Oklahoma, United States
Local Institution - 001-586-A
Bend, Oregon, United States
Local Institution - 001-586
Bend, Oregon, United States
Local Institution - 001-889
Eugene, Oregon, United States
Local Institution - 001-837
Allentown, Pennsylvania, United States
Local Institution - 001-837-A
Bethlehem, Pennsylvania, United States
Local Institution - 001-817
Hershey, Pennsylvania, United States
Local Institution - 001-783
Media, Pennsylvania, United States
Local Institution - 001-887
Charleston, South Carolina, United States
Local Institution - 001-819
Charleston, South Carolina, United States
Local Institution - 001-801-G
Gallatin, Tennessee, United States
Local Institution - 001-801-A
Hendersonville, Tennessee, United States
Local Institution - 001-801-D
Hermitage, Tennessee, United States
Local Institution - 001-801-F
Murfreesboro, Tennessee, United States
Local Institution - 001-801-B
Nashville, Tennessee, United States
Local Institution - 001-801
Nashville, Tennessee, United States
Local Institution - 001-801-E
Nashville, Tennessee, United States
Local Institution - 001-801-C
Nashville, Tennessee, United States
Local Institution - 001-888-B
Arlington, Texas, United States
Local Institution - 001-888
Arlington, Texas, United States
Local Institution - 001-880
Austin, Texas, United States
Local Institution - 001-848a
Conroe, Texas, United States
Local Institution - 001-809
Dallas, Texas, United States
Local Institution - 001-886
Dallas, Texas, United States
Local Institution - 001-879
Dallas, Texas, United States
Local Institution - 001-785
Denison, Texas, United States
Local Institution - 001-876
Fort Worth, Texas, United States
Local Institution - 001-848
Houston, Texas, United States
Local Institution - 001-969
Houston, Texas, United States
Local Institution - 001-935A
Houston, Texas, United States
Local Institution - 001-999
Irving, Texas, United States
Local Institution - 001-935D
Kingwood, Texas, United States
Local Institution - 001-935
Kingwood, Texas, United States
Local Institution - 001-554
Midland, Texas, United States
Local Institution - 001-802
San Antonio, Texas, United States
Local Institution - 001-935B
Shenandoah, Texas, United States
Local Institution - 001-935C
Spring, Texas, United States
Local Institution - 001-874
Sugar Land, Texas, United States
Local Institution - 001-935E
Tomball, Texas, United States
Local Institution - 001-878
Tyler, Texas, United States
Local Institution - 001-890
Waco, Texas, United States
Local Institution - 001-814
Fairfax, Virginia, United States
Local Institution - 001-597
Fredericksburg, Virginia, United States
Local Institution - 001-882
Newport News, Virginia, United States
Local Institution - 001-882-A
Norfolk, Virginia, United States
Local Institution - 001-890-A
Norfolk, Virginia, United States
Local Institution - 001-968
Richmond, Virginia, United States
Local Institution - 001-824
Seattle, Washington, United States
Local Institution - 001-885
Vancouver, Washington, United States
Local Institution - 001-804
Madison, Wisconsin, United States
Local Institution - 001-900
San Juan, PR, Puerto Rico
Countries
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References
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Negrao MV, Spira AI, Heist RS, Janne PA, Pacheco JM, Weiss J, Gadgeel SM, Velastegui K, Yang W, Der-Torossian H, Christensen JG, Sabari JK. Intracranial Efficacy of Adagrasib in Patients From the KRYSTAL-1 Trial With KRASG12C-Mutated Non-Small-Cell Lung Cancer Who Have Untreated CNS Metastases. J Clin Oncol. 2023 Oct 1;41(28):4472-4477. doi: 10.1200/JCO.23.00046. Epub 2023 Jun 16.
Bekaii-Saab TS, Yaeger R, Spira AI, Pelster MS, Sabari JK, Hafez N, Barve M, Velastegui K, Yan X, Shetty A, Der-Torossian H, Pant S. Adagrasib in Advanced Solid Tumors Harboring a KRASG12C Mutation. J Clin Oncol. 2023 Sep 1;41(25):4097-4106. doi: 10.1200/JCO.23.00434. Epub 2023 Apr 26.
Yaeger R, Weiss J, Pelster MS, Spira AI, Barve M, Ou SI, Leal TA, Bekaii-Saab TS, Paweletz CP, Heavey GA, Christensen JG, Velastegui K, Kheoh T, Der-Torossian H, Klempner SJ. Adagrasib with or without Cetuximab in Colorectal Cancer with Mutated KRAS G12C. N Engl J Med. 2023 Jan 5;388(1):44-54. doi: 10.1056/NEJMoa2212419. Epub 2022 Dec 21.
Janne PA, Riely GJ, Gadgeel SM, Heist RS, Ou SI, Pacheco JM, Johnson ML, Sabari JK, Leventakos K, Yau E, Bazhenova L, Negrao MV, Pennell NA, Zhang J, Anderes K, Der-Torossian H, Kheoh T, Velastegui K, Yan X, Christensen JG, Chao RC, Spira AI. Adagrasib in Non-Small-Cell Lung Cancer Harboring a KRASG12C Mutation. N Engl J Med. 2022 Jul 14;387(2):120-131. doi: 10.1056/NEJMoa2204619. Epub 2022 Jun 3.
Sabari JK, Velcheti V, Shimizu K, Strickland MR, Heist RS, Singh M, Nayyar N, Giobbie-Hurder A, Digumarthy SR, Gainor JF, Rajan AP, Nieblas-Bedolla E, Burns AC, Hallin J, Olson P, Christensen JG, Kurz SC, Brastianos PK, Wakimoto H. Activity of Adagrasib (MRTX849) in Brain Metastases: Preclinical Models and Clinical Data from Patients with KRASG12C-Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2022 Aug 2;28(15):3318-3328. doi: 10.1158/1078-0432.CCR-22-0383.
Ou SI, Janne PA, Leal TA, Rybkin II, Sabari JK, Barve MA, Bazhenova L, Johnson ML, Velastegui KL, Cilliers C, Christensen JG, Yan X, Chao RC, Papadopoulos KP. First-in-Human Phase I/IB Dose-Finding Study of Adagrasib (MRTX849) in Patients With Advanced KRASG12C Solid Tumors (KRYSTAL-1). J Clin Oncol. 2022 Aug 10;40(23):2530-2538. doi: 10.1200/JCO.21.02752. Epub 2022 Feb 15.
Awad MM, Liu S, Rybkin II, Arbour KC, Dilly J, Zhu VW, Johnson ML, Heist RS, Patil T, Riely GJ, Jacobson JO, Yang X, Persky NS, Root DE, Lowder KE, Feng H, Zhang SS, Haigis KM, Hung YP, Sholl LM, Wolpin BM, Wiese J, Christiansen J, Lee J, Schrock AB, Lim LP, Garg K, Li M, Engstrom LD, Waters L, Lawson JD, Olson P, Lito P, Ou SI, Christensen JG, Janne PA, Aguirre AJ. Acquired Resistance to KRASG12C Inhibition in Cancer. N Engl J Med. 2021 Jun 24;384(25):2382-2393. doi: 10.1056/NEJMoa2105281.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA239-0008
Identifier Type: OTHER
Identifier Source: secondary_id
849-001
Identifier Type: OTHER
Identifier Source: secondary_id
CA239-0008
Identifier Type: -
Identifier Source: org_study_id
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