A Phase IB Study of AMG 510 Combined with Other Drugs to Treat Metastatic Solid Tumors with the KRAS G12C mutation

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Full Title

A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation

Purpose

The purpose of this study is to assess the safety of giving the investigational drug AMG 510 (sotorasib) with other drugs such as trametinib, RMC-4630, AMG 404, atezolizumab, afatinib, or panitumumab in patients with solid tumors that contain a particular mutation called G12C in the KRAS gene and which spread despite prior treatment. AMG 510 traps the mutant KRAS protein and prevents it from signaling to other cells, thereby slowing or stopping cancer growth.

The other drugs work to enhance the effects of AMG 510 by either shutting down KRAS signaling or activating the immune system to attack the cancer. These drugs are considered investigational in this study. AMG 510 is taken orally (by mouth), and the other drugs are either taken orally or intravenously (by vein).

Eligibility

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

  • Patients must have a solid tumor that contains the KRAS G12C mutation and has spread despite prior treatment.
  • Patients with metastatic non-small cell lung cancer must have previously received immunotherapy or chemotherapy, and patients with metastatic colorectal cancer must have had two prior regimens of standard chemotherapy for that cancer.
  • Patients with primary brain tumors may not participate.
  • At least 4 weeks must pass since finishing chemotherapy or immunotherapy and 2 weeks since radiation therapy and the first day of a patient’s participation in 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 646-888-4226.

Protocol

20-183

Phase

I

Investigator