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

ID#: NCT04185883

Age: 18 - 100 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: December 17, 2019

End Date: October 31, 2025

Contact Information:
Amgen Call Center
Summary: To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

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.

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.