Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
2 other identifiers
interventional
610
12 countries
85
Brief Summary
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2019
Longer than P75 for phase_1
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2019
CompletedFirst Posted
Study publicly available on registry
December 4, 2019
CompletedStudy Start
First participant enrolled
December 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 5, 2027
October 22, 2025
October 1, 2025
7 years
December 3, 2019
October 21, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
Number of Participants with Dose Limiting Toxicities (DLTs)
12 Months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
12 Months
Number of Participants with Treatment-related Adverse Events
12 Months
Number of Participants with Clinically Significant Changes in Vital Signs
12 Months
Number of Participants with Clinically Significant Changes in ECG Measurements
12 Months
Number of Participants with Clinically Significant Changes in Laboratory Test Values
12 Months
Secondary Outcomes (25)
Maximum Plasma Concentration (Cmax)
12 Months
Time to Maximum Plasma Concentration (Tmax)
12 Months
Area Under the Plasma Concentration-time Curve (AUC)
12 Months
Objective Response Rate
12 Months
Disease Control Rate
12 Months
- +20 more secondary outcomes
Study Arms (14)
Sotorasib + trametinib + panitumumab
EXPERIMENTALExperimental: 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 + RMC-4630
EXPERIMENTALExperimental: 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 + afatinib
EXPERIMENTALExperimental: 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 + panitumumab +/- chemotherapy
EXPERIMENTALExperimental: 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 + atezolizumab
EXPERIMENTALExperimental: 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 + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab
EXPERIMENTALExperimental: 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 Monotherapy
EXPERIMENTALExperimental: 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 + palbociclib
EXPERIMENTALExperimental: 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 + pembrolizumab
EXPERIMENTALExperimental: 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 + MVASI® (bevacizumab-awwb)+ Chemotherapy
EXPERIMENTALExperimental: 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 + TNO155
EXPERIMENTALExperimental: 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 + BI 1701963
EXPERIMENTALExperimental: 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 + AMG 404
EXPERIMENTALExperimental: 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 + everolimus
EXPERIMENTALExperimental: 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.
Interventions
Sotorasib administered orally as a tablet.
pembrolizumab administered as an intravenous (IV) infusion.
Panitumumab administered as an IV infusion.
Carboplatin, pemetrexed, docetaxel administered as an IV infusion.
MVASI® (bevacizumab-awwb) administered as an IV infusion.
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 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.
Eligibility Criteria
You may qualify if:
- Men or women greater than or equal to 18 years old.
- 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.
You may not qualify if:
- Primary brain tumor.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (90)
Arizona Oncology Associates Professional Corporation
Tucson, Arizona, 85711, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Loma Linda University Cancer Center
Loma Linda, California, 92354, United States
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
University of California San Francisco Mission Bay Campus
San Francisco, California, 94115, United States
University of California Los Angeles
Santa Monica, California, 90404, United States
Rocky Mountain Cancer Centers Denver Midtown
Denver, Colorado, 80218, United States
Sarah Cannon Research Institute
Denver, Colorado, 80218, United States
Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Memorial Cancer Institute
Pembroke Pines, Florida, 33028, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
University of Michigan
Ann Arbor, Michigan, 48109-5912, United States
Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202, United States
Washington University
St Louis, Missouri, 63110-1093, United States
Roswell Park Cancer Institute
Buffalo, New York, 32224, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke University
Durham, North Carolina, 27710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Gibbs Cancer Center and Research Institute - Spartanburg
Spartanburg, South Carolina, 29303, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57108, United States
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Oncology Central-South
Austin, Texas, 78705, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Oncology Consultants
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
US Oncology Research Investigational Products Center
The Woodlands, Texas, 77380, United States
Texas Oncology Northeast Texas
Tyler, Texas, 75702, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22903, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684, United States
Nepean Cancer Centre
Kingswood, New South Wales, 2747, Australia
GenesisCare -North Shore Oncology
St Leonards, New South Wales, 2065, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, 4101, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
St John of God Healthcare
Subiaco, Western Australia, 6008, Australia
Medizinische Universitaet Graz
Graz, 8036, Austria
Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
CHU de Quebec Hopital de l Enfant Jesus
Québec, Quebec, G1J 1Z4, Canada
Charite Universitaetsmedizin Berlin, Campus Virchow
Berlin, 13353, Germany
Universitatsklinikum Koln
Cologne, 50937, Germany
Universitaetsklinikum Dresden
Dresden, 01307, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, 37126, Italy
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
Seoul National University Hospital
Seoul, 03080, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, 08908, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan District, 33305, Taiwan
Sarah Cannon Research Institute UK
London, W1G 6AD, United Kingdom
Related Publications (1)
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.
PMID: 38177853BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 3, 2019
First Posted
December 4, 2019
Study Start
December 17, 2019
Primary Completion (Estimated)
December 17, 2026
Study Completion (Estimated)
December 5, 2027
Last Updated
October 22, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request