AzTrials
AzTrials

Advanced CancerPhase 1/2NCT03785249

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

A Phase 1/2 study testing MRTX849, Pembrolizumab and Cetuximab in people with Advanced Cancer and Metastatic Cancer, run by Mirati Therapeutics Inc. at 222 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MRTX849, Pembrolizumab and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
731 participants
Where
222 sitesin 2 countries
Study dates
15 Jan 2019to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

222 sites in 2 countries.

222 sites in 2 countries

United States221 sites

  • Local Institution - 001-861

    Albany, New York, 12206

  • Local Institution - 001-837

    Allentown, Pennsylvania, 18103

  • Local Institution - 001-929i

    Altamonte Springs, Florida, 32701

  • Local Institution - 001-965

    Anchorage, Alaska, 99508

  • Local Institution - 001-888-B

    Arlington, Texas, 76012

  • Local Institution - 001-888

    Arlington, Texas, 76012

  • Local Institution - 001-967

    Athens, Georgia, 30607

  • Local Institution - 001-872

    Aurora, Colorado, 80012

  • Local Institution - 001-810

    Aurora, Colorado, 80045

  • Local Institution - 001-835-C

    Austell, Georgia, 30106

  • Local Institution - 001-835-E

    Austell, Georgia, 30106

  • Local Institution - 001-880

    Austin, Texas, 78731

  • Local Institution - 001-920

    Baton Rouge, Louisiana, 70809

  • Local Institution - 001-840-B

    Bellflower, California, 90706

  • Local Institution - 001-586-A

    Bend, Oregon, 97701

  • Local Institution - 001-586

    Bend, Oregon, 97701

  • Local Institution - 001-837-A

    Bethlehem, Pennsylvania, 18017

  • Local Institution - 001-834

    Beverly Hills, California, 90211

  • Local Institution - 001-827

    Biddeford, Maine, 04005

  • Local Institution - 001-841

    Billings, Montana, 59102

  • Local Institution - 001-826

    Birmingham, Alabama, 35294

  • Local Institution - 001-839

    Boca Raton, Florida, 33432

  • Local Institution - 001-952

    Bolivar, Missouri, 65613

  • Local Institution - 001-922A

    Bonita Springs, Florida, 34135

  • Local Institution - 001-808

    Boston, Massachusetts, 02215

  • Local Institution - 001-872-H

    Boulder, Colorado, 80303

  • Local Institution - 001-922D

    Bradenton, Florida, 34211

  • Local Institution - 001-929c

    Brandon, Florida, 33511

  • Local Institution - 001-881-B

    Brandywine, Maryland, 20613

  • Local Institution - 001-815

    Buffalo, New York, 14203

  • Local Institution - 001-922E

    Cape Coral, Florida, 33909

  • Local Institution - 001-835-D

    Carrollton, Georgia, 30117

  • Local Institution - 001-835-F

    Carrollton, Georgia, 30117

  • Local Institution - 001-835-A

    Cartersville, Georgia, 30121

  • Local Institution - 001-812

    Chapel Hill, North Carolina, 27514

  • Local Institution - 001-887

    Charleston, South Carolina, 29414

  • Local Institution - 001-819

    Charleston, South Carolina, 29425

  • Local Institution - 001-862

    Chicago Ridge, Illinois, 60415

  • Local Institution - 001-966

    Cincinnati, Ohio, 45219

  • Local Institution - 001-823

    Cincinnati, Ohio, 45267

  • Local Institution - 001-929g

    Clearwater, Florida, 33761

  • Local Institution - 001-818

    Cleveland, Ohio, 44195

  • Local Institution - 001-872-E

    Colorado Springs, Colorado, 80907

  • Local Institution - 001-872-L

    Colorado Springs, Colorado, 80920

  • Local Institution - 001-881

    Columbia, Maryland, 21044

  • Local Institution - 001-833 - H

    Columbus, Ohio, 43201

  • Local Institution - 001-833 - C

    Columbus, Ohio, 43203

  • Local Institution - 001-833 - J

    Columbus, Ohio, 43203

  • Local Institution - 001-833 - A

    Columbus, Ohio, 43210

  • Local Institution - 001-833 - F

    Columbus, Ohio, 43210

  • Local Institution - 001-833

    Columbus, Ohio, 43210

  • Local Institution - 001-833 - D

    Columbus, Ohio, 43212

  • Local Institution - 001-833 - I

    Columbus, Ohio, 43212

  • Local Institution - 001-930

    Columbus, Ohio, 43219

  • Local Institution - 001-833 - B

    Columbus, Ohio, 43221

  • Local Institution - 001-833 - G

    Columbus, Ohio, 43221

  • Local Institution - 001-848a

    Conroe, Texas, 77384

  • Local Institution - 001-838-F

    Coon Rapids, Minnesota, 55433

  • Local Institution - 001-809

    Dallas, Texas, 75230

  • Local Institution - 001-886

    Dallas, Texas, 75231

  • Local Institution - 001-879

    Dallas, Texas, 75246

  • Local Institution - 001-926b

    Daytona Beach, Florida, 32117

  • Local Institution - 001-785

    Denison, Texas, 75020

  • Local Institution - 001-872-B

    Denver, Colorado, 80218

  • Local Institution - 001-951 - A

    Denver, Colorado, 80218

  • Local Institution - 001-951 - B

    Denver, Colorado, 80218

  • Local Institution - 001-842

    Detroit, Michigan, 48201

  • Local Institution - 001-811

    Detroit, Michigan, 48202

  • Local Institution - 001-835-B

    Douglasville, Georgia, 30134

  • Local Institution - 001-843

    Duarte, California, 91010

  • Local Institution - 001-850-K

    Dublin, California, 94568

  • Local Institution - 001-838-E

    Edina, Minnesota, 55435

  • Local Institution - 001-875 - D

    Edina, Minnesota, 55435

  • Local Institution - 001-889

    Eugene, Oregon, 97401

  • Local Institution - 001-814

    Fairfax, Virginia, 22031

  • Local Institution - 001-842-A

    Farmington Hills, Michigan, 48334

  • Local Institution - 001-922

    Fort Myers, Florida, 33901

  • Local Institution - 001-922B

    Fort Myers, Florida, 33905

  • Local Institution - 001-922C

    Fort Myers, Florida, 33908

  • Local Institution - 001-876

    Fort Worth, Texas, 76104

  • Local Institution - 001-597

    Fredericksburg, Virginia, 24408

  • Local Institution - 001-851

    Fullerton, California, 92835

  • Local Institution - 001-833 - E

    Gahanna, Ohio, 43230

  • Local Institution - 001-929b

    Gainesville, Florida, 32605

  • Local Institution - 001-801-G

    Gallatin, Tennessee, 37066

  • Local Institution - 001-846

    Grand Junction, Colorado, 81501

  • Local Institution - 001-840-C

    Harbor City, California, 90710

  • Local Institution - 001-860A

    Henderson, Nevada, 89052

  • Local Institution - 001-860C

    Henderson, Nevada, 89052

  • Local Institution - 001-860B

    Henderson, Nevada, 89074

  • Local Institution - 001-860

    Henderson, Nevada, 89074

  • Local Institution - 001-801-A

    Hendersonville, Tennessee, 37075

  • Local Institution - 001-801-D

    Hermitage, Tennessee, 37076

  • Local Institution - 001-817

    Hershey, Pennsylvania, 17033-0850

  • Local Institution - 001-848

    Houston, Texas, 77030

  • Local Institution - 001-969

    Houston, Texas, 77030

  • Local Institution - 001-935A

    Houston, Texas, 77090

  • Local Institution - 001-831

    Iowa City, Iowa, 52242

  • Local Institution - 001-999

    Irving, Texas, 75063

  • Local Institution - 001-829

    Jacksonville, Florida, 32224

  • Local Institution - 001-950

    Jefferson City, Missouri, 65109

  • Local Institution - 001-836-A

    Kettering, Ohio, 45429

  • Local Institution - 001-836

    Kettering, Ohio, 45429

  • Local Institution - 001-935D

    Kingwood, Texas, 77339

  • Local Institution - 001-935

    Kingwood, Texas, 77339

  • Local Institution - 001-805

    La Jolla, California, 92093

  • Local Institution - 001-929m

    Lady Lake, Florida, 32159

  • Local Institution - 001-951

    Lafayette, Colorado, 80026

  • Local Institution - 001-872-A

    Lakewood, Colorado, 80228

  • Local Institution - 001-929e

    Largo, Florida, 33770

  • Local Institution - 001-860E

    Las Vegas, Nevada, 89128

  • Local Institution - 001-860D

    Las Vegas, Nevada, 89144

  • Local Institution - 001-860F

    Las Vegas, Nevada, 89148

  • Local Institution - 001-600

    Lawton, Oklahoma, 73505

  • Local Institution - 001-929n

    Lecanto, Florida, 34461

  • Local Institution - 001-844

    Lexington, Kentucky, 40536

  • Local Institution - 001-872-D

    Littleton, Colorado, 80218

  • Local Institution - 001-872-K

    Lone Tree, Colorado, 80124

  • Local Institution - 001-872-C

    Longmont, Colorado, 80501

  • Local Institution - 001-779

    Los Alamitos, California, 90720

  • Local Institution - 001-840

    Los Angeles, California, 90027

  • Local Institution - 001-578

    Los Angeles, California, 90067

  • Local Institution - 001-804

    Madison, Wisconsin, 53792

  • Local Institution - 001-838-D

    Maplewood, Minnesota, 55109

  • Local Institution - 001-875 - A

    Maplewood, Minnesota, 55109

  • Local Institution - 001-835

    Marietta, Georgia, 30060

  • Local Institution - 001-783

    Media, Pennsylvania, 19063

  • Local Institution - 001-870

    Miami, Florida, 33176

  • Local Institution - 001-825

    Miami Beach, Florida, 33140

  • Local Institution - 001-554

    Midland, Texas, 79701

  • Local Institution - 001-838-C

    Minneapolis, Minnesota, 55404

  • Local Institution - 001-875

    Minneapolis, Minnesota, 55404

  • Local Institution - 001-838-G

    Minneapolis, Minnesota, 55415

  • Local Institution - 001-822-A

    Minneapolis, Minnesota, 55455

  • Local Institution - 001-822

    Minneapolis, Minnesota, 55455

  • Local Institution - 001-801-F

    Murfreesboro, Tennessee, 37129

  • Local Institution - 001-922F

    Naples, Florida, 34102

  • Local Institution - 001-922G

    Naples, Florida, 34102

  • Local Institution - 001-801-B

    Nashville, Tennessee, 37203

  • Local Institution - 001-801

    Nashville, Tennessee, 37203

  • Local Institution - 001-801-E

    Nashville, Tennessee, 37207

  • Local Institution - 001-801-C

    Nashville, Tennessee, 37211

  • Local Institution - 001-816

    New Haven, Connecticut, 06510

  • Local Institution - 001-813

    New York, New York, 10016

  • Local Institution - 001-806

    New York, New York, 10065

  • Local Institution - 001-871

    Newark, Delaware, 19713-2055

  • Local Institution - 001-847

    Newport Beach, California, 92663

  • Local Institution - 001-882

    Newport News, Virginia, 23606

  • Local Institution - 001-883

    Niles, Illinois, 60714

  • Local Institution - 001-882-A

    Norfolk, Virginia, 23502

  • Local Institution - 001-890-A

    Norfolk, Virginia, 23502

  • Local Institution - 001-850-B

    Oakland, California, 94611

  • Local Institution - 001-538

    Ocala, Florida, 34474

  • Local Institution - 001-929p

    Ocala, Florida, 34474

  • Local Institution - 001-544B

    Omaha, Nebraska, 68105-1850

  • Local Institution - 001-959

    Omaha, Nebraska, 68114

  • Local Institution - 001-544A

    Omaha, Nebraska, 68118

  • Local Institution - 001-544

    Omaha, Nebraska, 68198

  • Local Institution - 001-803

    Orange, California, 92868

  • Local Institution - 001-914

    Orange City, Florida, 32763

  • Local Institution - 001-929j

    Orange City, Florida, 32763

  • Local Institution - 001-929l

    Orlando, Florida, 32806

  • Local Institution - 001-872-J

    Parker, Colorado, 80138

  • Local Institution - 001-877

    Pensacola, Florida, 32503

  • Local Institution - 001-821

    Phoenix, Arizona, 85054

  • Local Institution - 001-971

    Pinehurst, North Carolina, 28374

  • Local Institution - 001-922H

    Port Charlotte, Florida, 33980

  • Local Institution - 001-872-F

    Pueblo, Colorado, 81008

  • Local Institution - 001-872-G

    Pueblo, Colorado, 81008

  • Local Institution - 001-968

    Richmond, Virginia, 23229

  • Local Institution - 001-830

    Rochester, Minnesota, 55905

  • Local Institution - 001-850-C

    Roseville, California, 95661

  • Local Institution - 001-850-J

    Sacramento, California, 95814

  • Local Institution - 001-850-D

    Sacramento, California, 95825

  • Local Institution - 001-838

    Saint Louis Park, Minnesota, 55416

  • Local Institution - 001-838-B

    Saint Louis Park, Minnesota, 55426-5000

  • Local Institution - 001-838-A

    Saint Paul, Minnesota, 55101

  • Local Institution - 001-875 - B

    Saint Paul, Minnesota, 55102

  • Local Institution - 001-802

    San Antonio, Texas, 78229

  • Local Institution - 001-845

    San Diego, California, 92111

  • Local Institution - 001-840-A

    San Diego, California, 92120

  • Local Institution - 001-850-H

    San Francisco, California, 94080

  • Local Institution - 001-850-E

    San Francisco, California, 94115

  • Local Institution - 001-850-F

    San Jose, California, 95119

  • Local Institution - 001-850-A

    San Leandro, California, 94577

  • Local Institution - 001-884

    Santa Barbara, California, 93105

  • Local Institution - 001-850-I

    Santa Clara, California, 95051

  • Local Institution - 001-922I

    Sarasota, Florida, 34232

  • Local Institution - 001-922J

    Sarasota, Florida, 34236

  • Local Institution - 001-824

    Seattle, Washington, 98109

  • Local Institution - 001-935B

    Shenandoah, Texas, 77380

  • Local Institution - 001-881-A

    Silver Spring, Maryland, 20904

  • Local Institution - 001-884-A

    Solvang, California, 93463

  • Local Institution - 001-781

    South Bend, Indiana, 46601

  • Local Institution - 001-935C

    Spring, Texas, 77389

  • Local Institution - 001-929h

    Spring Hill, Florida, 34608

  • Local Institution - 001-929a

    St. Petersburg, Florida, 33705

  • Local Institution - 001-929

    St. Petersburg, Florida, 33705

  • Local Institution - 001-926d

    Stuart, Florida, 34994

  • Local Institution - 001-874

    Sugar Land, Texas, 77479

  • Local Institution - 001-929d

    Tampa, Florida, 33607

  • Local Institution - 001-929k

    Tavares, Florida, 32778

  • Local Institution - 001-872-I

    Thornton, Colorado, 80260

  • Local Institution - 001-935E

    Tomball, Texas, 77375

  • Local Institution - 001-929f

    Trinity, Florida, 34655

  • Local Institution - 001-873-A

    Tucson, Arizona, 85704

  • Local Institution - 001-873

    Tucson, Arizona, 85704

  • Local Institution - 001-584

    Tulsa, Oklahoma, 74146

  • Local Institution - 001-878

    Tyler, Texas, 75702

  • Local Institution - 001-850

    Vallejo, California, 94589

  • Local Institution - 001-885

    Vancouver, Washington, 98684

  • Local Institution - 001-922K

    Venice, Florida, 34285

  • Local Institution - 001-922L

    Venice, Florida, 34292

  • Local Institution - 001-926c

    Vero Beach, Florida, 32960

  • Local Institution - 001-890

    Waco, Texas, 76712

  • Local Institution - 001-850-G

    Walnut Creek, California, 94596

  • Local Institution - 001-926a

    Wellington, Florida, 33414

  • Local Institution - 001-926

    West Palm Beach, Florida, 33401

  • Local Institution - 001-820

    Westwood, Kansas, 66205

  • Local Institution - 001-929o

    Winter Park, Florida, 32789

  • Local Institution - 001-875 - C

    Woodbury, Minnesota, 55125

Other trials in United States

Puerto Rico1 site

  • Local Institution - 001-900

    San Juan, PR, 00935

Other trials in Puerto Rico

About this study

Official title: 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.

Read the 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.

Being tested
MRTX849, Pembrolizumab, Cetuximab, Afatinib
Keywords
KRAS, NSCLC, Colorectal Cancer, Colon Cancer, Metastatic Cancer, Pancreatic Cancer, Adagrasib, STK11 mutation, KRAS G12C
Medical subject headings
Neoplasm Metastasis, Neoplasms, Colorectal Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRTX849Drug

    MRTX849 will be administered orally once or twice daily in a continuous regimen

  • PembrolizumabDrug

    Pembrolizumab is administered as an intravenous infusion once every 3 weeks

  • CetuximabDrug

    Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks

  • AfatinibDrug

    Afatinib will be administered orally once a day in a continuous regimen

Study groups in NCT03785249
Study groupRoleWhat they receive
Phase 1 Dose ExplorationExperimentalDose escalation of MRTX849 to determine maximum tolerated dose
Receives: Drug: MRTX849
Phase 1b ExpansionExperimentalExpansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens
Receives: Drug: MRTX849
Phase 2ExperimentalSeparate cohorts of patients stratified by histological diagnosis, prior treatment history or co-mutation status (e.g., STK11) for evaluation of clinical activity of MRTX849
Receives: Drug: MRTX849
Pilot Phase 1b Combination with PembrolizumabExperimentalPhase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with pembrolizumab in patients with NSCLC
Receives: Drug: MRTX849; Drug: Pembrolizumab
Pilot Phase 1b Combination with CetuximabExperimentalPhase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with CRC
Receives: Drug: MRTX849; Drug: Cetuximab
Pilot Phase 1b Combination with AfatinibExperimentalPhase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC
Receives: Drug: MRTX849; Drug: Afatinib
Phase 2 Combination with CetuximabExperimentalPhase 2 evaluation of the clinical activity of MRTX849 in combination with cetuximab in patients with CRC
Receives: Drug: MRTX849; Drug: Cetuximab
Pilot Phase 1b Combination with Cetuximab in NSCLCExperimentalPhase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with NSCLC
Receives: Drug: MRTX849; Drug: Cetuximab
Pilot Phase 1b Combination with Cetuximab in PDACExperimentalPhase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with pancreatic adenocarcinoma (PDAC)
Receives: Drug: MRTX849; Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation

    Number of participants with treatment related adverse events

    Measured: 20 months

  2. Evaluate the pharmacokinetics of MRTX849

    Blood plasma concentration

    Measured: 20 months

  3. Evaluate clinical activity/efficacy of MRTX849

    Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: 20 months

Secondary outcomes (4)

  1. Establish maximum tolerated dose

    Number of participants with dose limiting toxicity

    Measured: 12 months

  2. Characterize safety and tolerability of MRTX849 in combination with selected therapeutic agents

    Number of participants with dose limiting toxicity

    Measured: 12 months

  3. Evaluate the pharmacokinetics of new MRTX849 oral formulations

    Blood plasma concentration

    Measured: 6 months

  4. Evaluate the pharmacokinetics of MRTX849 administered with food

    Blood plasma concentration

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2018
  2. Study start15 Jan 2019
  3. Primary completion23 Jun 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
731 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03785249
Sponsor's protocol ID
CA239-0008
Other IDs
CA239-0008, 849-001
Status last verified
Jul 2026
First submitted
18 Dec 2018
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Publications

  • 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.

    PubMed 37327468

  • 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.

    PubMed 37099736

  • 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.

    PubMed 36546659

  • 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.

    PubMed 35658005

  • 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.

    PubMed 35404402

  • 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.

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  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MRTX849, Pembrolizumab and Cetuximab in people with Advanced Cancer and Metastatic Cancer, run by Mirati Therapeutics Inc. at 222 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 222 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation (time frame: 20 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03785249, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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