A Phase I Study of AMG 510 to Treat Advanced KRAS G12C-Mutant Solid Tumors

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Full Title

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

Purpose

The purpose of this study is to find the safety and effectiveness of the investigational drug AMG 510 in patients with metastatic solid tumors that contain a particular G12C mutation in the KRAS gene and have continued to grow or came back after previous treatment. AMG 510 attaches to the mutant KRAS protein and prevents it from signaling to other cells, thereby slowing or stopping cancer growth. AMG 510 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a recurrent or persistent metastatic solid tumor that contains the KRAS G12C mutation. Examples include some types of non-small cell lung cancer and colorectal cancer.
  • At least 4 weeks must pass since the completion of prior treatment (2 weeks since radiation therapy) and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Bob Li at 646-888-4201.

Protocol

19-072

Phase

I

Disease Status

Relapsed or Refractory

Investigator