A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Olomorasib in Combination With Cetuximab and mFOLFOX6 in Participants With KRAS G12C-Mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer
Eli Lilly and Company
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed colorectal cancer (CRC) with Stage III or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy. * Must have disease with evidence of KRAS G12C mutation * Have measurable disease per RECIST v1.1. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Ability to swallow capsules. * Have adequate laboratory parameters. * Have not received treatment for their CRC that has spread to other parts of the body. * 1-2 cycles of FOLFOX prior to study enrollment will be allow…
Interventions
- DrugOlomorasib
Administered orally
- DrugCetuximab
Administered IV
- DrugOxaliplatin
Administered IV
- DrugLeucovorin/levofolinate calcium
Administered IV
- Drug5-fluorouracil
Administered IV
Locations (18)
- University of Alabama at BirminghamBirmingham, Alabama
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- AdventHealth OrlandoOrlando, Florida
- Dana-Farber Cancer InstituteBoston, Massachusetts
- START Astera, LLCEast Brunswick, New Jersey
- Texas Oncology - Central SouthAustin, Texas