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

  • Interventional
  • Recruiting
  • NCT04185883
Eligibility Details Visit

A Phase 1b/2, 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)

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


Age Group
18 Years to 100 Years

Accepting Healthy Volunteers?

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.
  • Advanced Solid Tumors
  • Solid Tumors

At a Glance

National Government IDNCT04185883


Lead SponsorAmgen

Lead PhysicianChristine Bestvina


18 Years to 100 Years