Olomorasib for Colorectal Cancer

Not yet recruiting at 17 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The main purpose of this study is to evaluate how well olomorasib is tolerated and what side effects may occur when combined with other interventions in participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C-mutant, locally advanced colorectal cancer (CRC) that cannot be removed with surgery or has spread to other parts of the body. Blood tests will be performed to investigate how the body processes the study drug.

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with advanced colorectal cancer that has a KRAS G12C mutation and cannot be removed by surgery or cured with radiation. Participants must not have had treatment for cancer that has spread, need to be in good physical condition, able to swallow capsules, and have working major organs.

Inclusion Criteria

My recent lab test results are within the normal range.
I have received only 1-2 cycles of FOLFOX before joining this study.
I am able to swallow capsules.
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • 5-fluorouracil
  • Cetuximab
  • Leucovorin/levofolinate calcium
  • Olomorasib
  • Oxaliplatin

Trial Overview

The study tests the safety and effects of olomorasib alone or combined with other drugs (cetuximab, oxaliplatin, leucovorin/levofolinate calcium, 5-fluorouracil) in people with advanced KRAS G12C-mutant colorectal cancer. Blood samples will help understand how the drug works in the body.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Olomorasib + Cetuximab + mFOLFOX6Experimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University