A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

Completed · Phase 1/Phase 2

Conditions studied: KRAS p.G12C Mutant Advanced Solid Tumors

In brief

Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Key facts

Study ID

NCT03600883

Run by

Amgen

People needed

713

Starts

2018-08-27

Expected to finish

2026-05-29

Last updated by the study team

2026-06-30

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.

You may not qualify if…

• Active brain metastases 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

• University of California Los Angeles — Los Angeles, California, United States
• University of California at SF — San Francisco, California, United States
• Sarcoma Oncology Research Center LLC — Santa Monica, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
• Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States
• Medical Oncology Hematology Consultants Helen F Graham Cancer Center — Newark, Delaware, United States
• University of Florida Health — Gainesville, Florida, United States
• AdventHealth Orlando Infusion Center — Orlando, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• American Oncology Partners of Maryland, PA — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Laura and Isaac Perlmutter Cancer Center at New York University Langone — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center, Morris Cancer Clinic — Durham, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• City of Hope National Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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