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

July 28, 2026 updated by: Mirati Therapeutics Inc.

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
731

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain the NCT# and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1 Dose Exploration
Dose escalation of MRTX849 to determine maximum tolerated dose
Drug: MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Experimental: 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
Drug: MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Experimental: 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
Drug: MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Experimental: 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
Drug: MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Drug: Pembrolizumab
Pembrolizumab is administered as an intravenous infusion once every 3 weeks
Experimental: 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
Drug: MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Drug: Cetuximab
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
Experimental: 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
Drug: MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Drug: Afatinib
Afatinib will be administered orally once a day in a continuous regimen
Experimental: Phase 2 Combination with Cetuximab
Phase 2 evaluation of the clinical activity of MRTX849 in combination with cetuximab in patients with CRC
Drug: MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Drug: Cetuximab
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
Experimental: 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
Drug: MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Drug: Cetuximab
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
Experimental: 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)
Drug: MRTX849
MRTX849 will be administered orally once or twice daily in a continuous regimen
Drug: Cetuximab
Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation
Time Frame: 20 months
Number of participants with treatment related adverse events
20 months
Evaluate the pharmacokinetics of MRTX849
Time Frame: 20 months
Blood plasma concentration
20 months
Evaluate clinical activity/efficacy of MRTX849
Time Frame: 20 months
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
20 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Establish maximum tolerated dose
Time Frame: 12 months
Number of participants with dose limiting toxicity
12 months
Characterize safety and tolerability of MRTX849 in combination with selected therapeutic agents
Time Frame: 12 months
Number of participants with dose limiting toxicity
12 months
Evaluate the pharmacokinetics of new MRTX849 oral formulations
Time Frame: 6 months
Blood plasma concentration
6 months
Evaluate the pharmacokinetics of MRTX849 administered with food
Time Frame: 6 months
Blood plasma concentration
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mirati Therapeutics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA239-0008 (Other Identifier: Bristol-Myers Squibb Protocol ID)
  • 849-001 (Other Identifier: Mirati Therapeutics Protocol ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings