A Study of Olomorasib (LY3537982) in Participants With Advanced Colorectal Cancer and a KRAS G12C Mutation

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 allowed for cases where immediate treatment is clinically indicated.

Exclusion criteria

• Have active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.
• Have a clinically significant active malabsorption syndrome or other conditions likely to affect gastrointestinal absorption of the orally administered study treatments.
• Have known untreated active central nervous system metastases or carcinomatous meningitis.
• Have known additional malignancy that is progressing or has required treatment within the past 2 years.
• Have uncontrolled, significant cardiovascular disease or cerebrovascular disease.
• Have an active fungal, bacterial, or active, untreated viral infection.
• Have human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma or Multicentric Castleman's Disease.
• Have known B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E gene mutation.
• Have confirmed Microsatellite Instability-High/deficient Mismatch Repair (MSI-H/dMMR).
• Individuals with known low or absent dihydropyrimidine dehydrogenase activity.
• Have known positive Immunoglobulin E (IgE) antibodies against galactose-α-1,3-galactose (alpha-gal).
• Have received adjuvant, neoadjuvant, concurrent chemoradiotherapy, or consolidation therapy if treatment was completed less than 6 months prior to enrollment.
• Are pregnant, breastfeeding, or intend to become pregnant during the study.