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20170543 A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects with Advanced Solid Tumors with KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subject

NCT03600883

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects with Advanced Solid Tumors with KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects with Advanced NSCLC with KRAS p.G12C Mutation

Associated Conditions

Multiple Tumor Types

Principal Investigator

Sponsor

Amgen

This study will be conducted in 2 phases: Phase 1 and Phase 2. You will only participate in one phase of the study. The purpose of this Phase 1 study is to see at what dose of AMG 510 is recommended for participants to receive and determine an active dose for Phase 2, to obtain initial information on the safety and tolerability (good or bad effects), and to see how AMG 510 works inside the body when orally administered (taken by mouth) alone, or in combination with intravenously administered (taken through a vein) pembrolizumab. A small percentage of participants will participate in the group that includes both AMG 510 and pembrolizumab. Your study doctor will let you know which study drugs you will receive. The purpose of the Phase 2 study is to see how well orally administered AMG 510 works at the dose determined in the Phase 1 study, and to obtain information on the safety and tolerability (good and bad effects) of AMG 510.

This study is currently enrolling.