Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Launched by AMGEN · Dec 3, 2019
Trial Information
Current as of August 29, 2025
Recruiting
Keywords
ClinConnect Summary
The clinical trial titled "Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation" is looking at a new treatment called sotorasib for adults with advanced solid tumors that have a specific genetic change known as the KRAS p.G12C mutation. This trial aims to understand how safe and well-tolerated this medication is when given to participants. If you or a loved one is an adult aged 18 or older and has been diagnosed with a locally advanced or metastatic cancer that shows this KRAS mutation, you may be eligible to participate in this study.
Potential participants should note that certain health conditions may exclude them from the trial, such as having a primary brain tumor or recent heart issues. Those interested in joining can expect to receive the investigational treatment and regular health check-ups throughout the trial to monitor their condition and any side effects. The trial is currently recruiting participants, and it provides a unique opportunity to contribute to research that could help others facing similar health challenges.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
About Amgen
Amgen is a leading global biotechnology company dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. With a strong focus on areas such as oncology, cardiovascular disease, and inflammation, Amgen leverages advanced science and technology to address complex medical needs. The company is committed to improving patient outcomes through rigorous clinical trials and robust research initiatives, ensuring the highest standards of safety and efficacy in its products. With a rich pipeline of cutting-edge therapies, Amgen continues to be at the forefront of biopharmaceutical advancements, making a significant impact on healthcare worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Philadelphia, Pennsylvania, United States
Durham, North Carolina, United States
New York, New York, United States
Chicago, Illinois, United States
Cleveland, Ohio, United States
New York, New York, United States
Buffalo, New York, United States
Iowa City, Iowa, United States
Philadelphia, Pennsylvania, United States
Sacramento, California, United States
Salt Lake City, Utah, United States
New York, New York, United States
Madrid, , Spain
Duarte, California, United States
Seattle, Washington, United States
Portland, Oregon, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Detroit, Michigan, United States
Durham, North Carolina, United States
Indianapolis, Indiana, United States
Cleveland, Ohio, United States
Nashville, Tennessee, United States
Bronx, New York, United States
Portland, Oregon, United States
Dallas, Texas, United States
Chicago, Illinois, United States
Tacoma, Washington, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Woodville South, South Australia, Australia
Seattle, Washington, United States
New York, New York, United States
Taipei, , Taiwan
Seattle, Washington, United States
Essen, , Germany
Norwalk, Connecticut, United States
Charlottesville, Virginia, United States
Barcelona, , Spain
Cincinnati, Ohio, United States
Pittsburgh, Pennsylvania, United States
New Haven, Connecticut, United States
Taipei, , Taiwan
Loma Linda, California, United States
New Haven, Connecticut, United States
Seoul, , Korea, Republic Of
Essen, , Germany
Seoul, , Korea, Republic Of
Madrid, , Spain
Taipei, , Taiwan
Dresden, , Germany
Fairfax, Virginia, United States
Pembroke Pines, Florida, United States
Seoul, , Korea, Republic Of
Tainan, , Taiwan
Seoul, , Korea, Republic Of
Edegem, , Belgium
Tainan, , Taiwan
Los Angeles, California, United States
Dresden, , Germany
Charlotte, North Carolina, United States
Graz, , Austria
Austin, Texas, United States
Utrecht, , Netherlands
Salzburg, , Austria
Tyler, Texas, United States
Pisa, , Italy
Taipei, , Taiwan
Houston, Texas, United States
La Jolla, California, United States
South Brisbane, Queensland, Australia
Majadahonda, Madrid, Spain
Ann Arbor, Michigan, United States
New York, New York, United States
London, , United Kingdom
Vancouver, Washington, United States
Denver, Colorado, United States
Köln, , Germany
Charlottesville, Virginia, United States
Tyler, Texas, United States
Santa Monica, California, United States
Pittsburgh, Pennsylvania, United States
Denver, Colorado, United States
Subiaco, Western Australia, Australia
Nashville, Tennessee, United States
Dallas, Texas, United States
Barcelona, Cataluña, Spain
Kashiwa Shi, Chiba, Japan
Koto Ku, Tokyo, Japan
Bruxelles, , Belgium
Berlin, , Germany
Barcelona, Cataluña, Spain
Koeln, , Germany
Berlin, , Germany
Milano, , Italy
Seoul, , Korea, Republic Of
Chicago, Illinois, United States
Saint Louis, Missouri, United States
Salzburg, , Austria
San Francisco, California, United States
Spartanburg, South Carolina, United States
Fairfax, Virginia, United States
Nagoya Shi, Aichi, Japan
Taoyuan, , Taiwan
Denver, Colorado, United States
The Woodlands, Texas, United States
Barcelona, , Spain
Sioux Falls, South Dakota, United States
Tucson, Arizona, United States
Atlanta, Georgia, United States
Baltimore, Maryland, United States
Philadelphia, Pennsylvania, United States
Fairfax, Virginia, United States
Kingswood, New South Wales, Australia
St Leonards, New South Wales, Australia
Quebec, , Canada
Hospitalet De Llobregat, Cataluña, Spain
Pisa, , Italy
Berlin, , Germany
Buffalo, New York, United States
Verona, , Italy
The Woodlands, Texas, United States
Pisa, , Italy
Hospitalet De Llobregat, Cataluña, Spain
St Leonards, New South Wales, Australia
Berlin, , Germany
Hospitalet De Llobregat, Cataluña, Spain
Verona, , Italy
San Francisco, California, United States
Austin, Texas, United States
Detroit, Michigan, United States
Nashville, Tennessee, United States
Hospitalet De Llobregat, , Spain
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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