A Phase III Study of MRTX849 Combined with Cetuximab versus Chemotherapy in People with KRAS G12C-Mutated Advanced Colorectal Cancer that Continues to Grow

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Full Title

A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy

Purpose

In this study, researchers are comparing the effectiveness of combining the investigational drug MRTX849 (also known as adagrasib) plus cetuximab versus standard chemotherapy (either FOLFIRI or mFOLFOX6) in people with advanced colorectal cancer that continues to grow despite initial treatment and contains a mutation in the KRAS G12C gene.

MRTX849 was designed to target the KRAS G12C mutation and prevent it from sending signals to “turn on” cancer cells so they can grow and spread. Cetuximab attaches to a protein called EGFR in cancer cells, which may slow or stop the growth of the tumor. Researchers think that combining MRTX849 with cetuximab may be an effective treatment for people with KRAS G12C-mutated advanced colorectal cancer that has progressed after treatment.

Participants in this study will be randomly assigned to receive either MRTX849 plus cetuximab OR standard chemotherapy with FOLFIRI or mFOLFOX6. MRTX849 is taken orally (by mouth) and the other medications are given 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 KRAS G12C-mutated advanced colorectal cancer that continues to grow despite initial treatment.
  • The serious side effects of previous treatments should resolve before receiving the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, they must be well enough that they would be able to carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Rona Yaeger at 646-888-5109.

Protocol

21-313

Phase

III

Investigator

Co-Investigators