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AMG 510 Ethnic Sensitivity Study (CodeBreak 105).

AMG 510 Ethnic Sensitivity Study (CodeBreak 105).

Recruiting
18 years and older
All
Phase 1

Overview

To evaluate safety, tolerability, PK, and preliminary efficacy of AMG 510 PO QD in subjects of Chinese descent with KRAS p.G12C-mutant advanced/metastatic solid tumors.

Eligibility

Inclusion Criteria

  • Male or female subjects greater than or equal to 18 years old
  • Subject is of Chinese ancestry
  • Pathologically documented, advanced/metastatic solid tumor with KRAS p.G12C mutation identified

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

Study details
    Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation

NCT04380753

Amgen

16 February 2024

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