A Phase I Study of GDC-6036 in People with Metastatic Lung Cancer with a KRAS G12C Mutation

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Full Title

A Phase I Dose-Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-6036 in Patients with Advanced or Metastatic Solid Tumors with a KRAS G12C Mutation

Purpose

The purpose of this study is to find the highest dose of the investigational drug GDC-6036 that can be given safely in patients with metastatic non-small cell lung cancer (NSCLC) that has come back or continued to grow despite treatment and contains a mutation in a gene called KRAS G12C. GDC-6036 was designed to block the KRAS G12C gene. GDC-6036 is a capsule that 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 metastatic NSCLC that contains the KRAS G12C mutation.
  • At least 3 weeks must pass since completing prior treatment (4 weeks since radiation treatment) and receipt of GDC-6036.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Kathryn Arbour at 646-608-3792.

Protocol

20-562

Phase

I

Investigator

Co-Investigators