Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Running, not enrolling · Phase 1

Conditions studied: Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation

In brief

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Key facts

Study ID

NCT04185883

Run by

Amgen

People needed

610

Starts

2019-12-17

Expected to finish

2027-12-05

Last updated by the study team

2025-10-22

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Arizona Oncology Associates Professional Corporation — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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