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

• Status: Recruiting
• Trial end date: 2026-07-14
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the safety and tolerability of AMG 510 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.

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

Details

• Lead Sponsor: Amgen
• Treatments: Midazolam

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

• 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.