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

• Status: Recruiting
• Trial end date: 2026-01-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Afatinib; Atezolizumab; Bevacizumab; Carboplatin; Docetaxel; Everolimus; Loperamide; Palbociclib; Panitumumab; Pembrolizumab; Pemetrexed; Trametinib

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.

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.