Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
NCT ID: NCT04185883
Last Updated: 2025-10-22
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
610 participants
INTERVENTIONAL
2019-12-17
2027-12-05
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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Sotorasib + palbociclib
Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.
Sotorasib
Sotorasib administered orally as a tablet.
Palbociclib
Palbociclib administered orally as a tablet.
Sotorasib + pembrolizumab
Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant non small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS P.G12C mutant non small cell lung cancer.
Sotorasib
Sotorasib administered orally as a tablet.
Pembrolizumab
pembrolizumab administered as an intravenous (IV) infusion.
Sotorasib + trametinib + panitumumab
Experimental: Sotorasib + trametinib + panitumumab Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
Sotorasib
Sotorasib administered orally as a tablet.
Trametinib
Trametinib administered orally as a tablet.
Panitumumab
Panitumumab administered as an IV infusion.
Sotorasib + RMC-4630
Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants, with KRAS p.G12C mutant advanced solid tumors.
Sotorasib
Sotorasib administered orally as a tablet.
RMC-4630
RMC-4630 administered orally as a capsule.
Sotorasib + afatinib
Experimental: Sotorasib + afatinib Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
Sotorasib
Sotorasib administered orally as a tablet.
Afatinib
afatinib administered orally as a tablet.
Sotorasib + panitumumab +/- chemotherapy
Experimental: Sotorasib + panitumumab +/- chemotherapy Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
Sotorasib
Sotorasib administered orally as a tablet.
Panitumumab
Panitumumab administered as an IV infusion.
IV Chemotherapy (Regimen 1)
Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.
Sotorasib + atezolizumab
Experimental: Sotorasib + atezolizumab Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
Sotorasib
Sotorasib administered orally as a tablet.
Atezolizumab
Atezolizumab administered as an IV injection.
Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab
Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.
Sotorasib
Sotorasib administered orally as a tablet.
Pembrolizumab
pembrolizumab administered as an intravenous (IV) infusion.
Carboplatin, pemetrexed, docetaxel, paclitaxel
Carboplatin, pemetrexed, docetaxel administered as an IV infusion.
Sotorasib Monotherapy
Experimental: Sotorasib only Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer with brain metastases.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer with brain metastases.
Sotorasib
Sotorasib administered orally as a tablet.
Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy
Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ chemotherapy Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced colorectal cancer.
Sotorasib
Sotorasib administered orally as a tablet.
MVASI® (bevacizumab-awwb)
MVASI® (bevacizumab-awwb) administered as an IV infusion.
IV Chemotherapy (Regimen 1)
Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.
IV Chemotherapy (Regimen 2)
IV chemotherapy combination of leucovorin administered as an IV injection, 5-FU administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.
Sotorasib + TNO155
Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.
Sotorasib
Sotorasib administered orally as a tablet.
TNO155
TNO155 administered orally as a capsule.
Sotorasib + BI 1701963
Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion
* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.
* Upon completion of dose exploration part of the study the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer and advanced colorectal cancer.
Sotorasib
Sotorasib administered orally as a tablet.
BI 1701963
BI 1701963 administered orally
Sotorasib + AMG 404
Experimental: Sotorasib + AMG 404 Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors
Sotorasib
Sotorasib administered orally as a tablet.
AMG 404
AMG 404 administered as an IV infusion.
Sotorasib + everolimus
Experimental: Sotorasib + everolimus Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.
Sotorasib
Sotorasib administered orally as a tablet.
Everolimus
Everolimus administered orally.
Interventions
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Sotorasib
Sotorasib administered orally as a tablet.
Trametinib
Trametinib administered orally as a tablet.
RMC-4630
RMC-4630 administered orally as a capsule.
Afatinib
afatinib administered orally as a tablet.
Pembrolizumab
pembrolizumab administered as an intravenous (IV) infusion.
Panitumumab
Panitumumab administered as an IV infusion.
Carboplatin, pemetrexed, docetaxel, paclitaxel
Carboplatin, pemetrexed, docetaxel administered as an IV infusion.
Atezolizumab
Atezolizumab administered as an IV injection.
Palbociclib
Palbociclib administered orally as a tablet.
MVASI® (bevacizumab-awwb)
MVASI® (bevacizumab-awwb) administered as an IV infusion.
TNO155
TNO155 administered orally as a capsule.
IV Chemotherapy (Regimen 1)
Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.
IV Chemotherapy (Regimen 2)
IV chemotherapy combination of leucovorin administered as an IV injection, 5-FU administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.
BI 1701963
BI 1701963 administered orally
AMG 404
AMG 404 administered as an IV infusion.
Everolimus
Everolimus administered orally.
Eligibility Criteria
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Inclusion Criteria
* Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
Exclusion Criteria
* Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
* Myocardial infarction within 6 months of study day 1.
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Arizona Oncology Associates Professional Corporation
Tucson, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
University of California San Diego Moores Cancer Center
La Jolla, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California San Francisco Mission Bay Campus
San Francisco, California, United States
University of California Los Angeles
Santa Monica, California, United States
Rocky Mountain Cancer Centers Denver Midtown
Denver, Colorado, United States
Sarah Cannon Research Institute
Denver, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Memorial Cancer Institute
Pembroke Pines, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Gibbs Cancer Center and Research Institute - Spartanburg
Spartanburg, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology Central-South
Austin, Texas, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Oncology Consultants
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
US Oncology Research Investigational Products Center
The Woodlands, Texas, United States
Texas Oncology Northeast Texas
Tyler, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, United States
Nepean Cancer Centre
Kingswood, New South Wales, Australia
GenesisCare -North Shore Oncology
St Leonards, New South Wales, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
St John of God Healthcare
Subiaco, Western Australia, Australia
Medizinische Universitaet Graz
Graz, , Austria
Landeskrankenhaus Salzburg
Salzburg, , Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
CHU de Quebec Hopital de l Enfant Jesus
Québec, Quebec, Canada
Charite Universitaetsmedizin Berlin, Campus Virchow
Berlin, , Germany
Universitatsklinikum Koln
Cologne, , Germany
Universitaetsklinikum Dresden
Dresden, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, , Italy
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan District, , Taiwan
Sarah Cannon Research Institute UK
London, , United Kingdom
Countries
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References
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Kuboki Y, Fakih M, Strickler J, Yaeger R, Masuishi T, Kim EJ, Bestvina CM, Kopetz S, Falchook GS, Langer C, Krauss J, Puri S, Cardona P, Chan E, Varrieur T, Mukundan L, Anderson A, Tran Q, Hong DS. Sotorasib with panitumumab in chemotherapy-refractory KRASG12C-mutated colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):265-270. doi: 10.1038/s41591-023-02717-6. Epub 2024 Jan 4.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-506794-35
Identifier Type: OTHER
Identifier Source: secondary_id
20190135
Identifier Type: -
Identifier Source: org_study_id
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