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)

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03600883

Patient View

This Phase 1/2 trial assesses sotorasib's safety and pharmacokinetics in adults with KRAS p.G12C mutant advanced solid tumors. Eligible participants are 18+ with documented KRAS p.G12C mutations. Exclusions include active brain metastases and recent myocardial infarction. Interventions include oral sotorasib, IV Anti PD-1/L1, and oral midazolam.

Patient Parameters

Program Overview

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.

Eligibility 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.

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