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Not yet recruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Blood tests will be performed to investigate how the body processes the study drug."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and side effects of olomorasib with other treatments for advanced colon or rectal cancer with a KRAS G12C gene change. It is for people whose cancer cannot be removed by surgery or has spread. Blood tests will show how the body processes the study drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage III or IV colon or rectal cancer confirmed by a tissue or cell test. Surgery or radiation cannot be used to cure it.
  • Have cancer with a KRAS G12C gene change.
  • Have cancer that can be measured using the study’s rules.
  • Can do daily activities with no limits or only limits on hard physical activity.
  • Can swallow capsules.
  • Have lab test results that meet the study’s requirements.
  • Have not had treatment for cancer that has spread. One or two cycles of FOLFOX chemotherapy may be allowed if treatment was needed right away.

Who can't join

  • Have a history of inflammatory bowel disease, or active bowel inflammation needing medicine that lowers immune activity. Also excluded: conditions that keep the gut from properly absorbing study medicines.
  • Have known active, untreated cancer spread to the brain or spinal cord, or cancer in the tissue covering them.
  • Have another cancer that is getting worse or needed treatment in the past 2 years.
  • Have serious, uncontrolled heart or blood vessel disease, including disease affecting blood flow to the brain.
  • Have an active fungal or bacterial infection, or an active, untreated viral infection. Also excluded: HIV with a history of Kaposi’s sarcoma or Multicentric Castleman’s disease.
  • Have a BRAF V600E gene change; MSI-H/dMMR, meaning cancer cells have problems repairing DNA; low or missing DPD enzyme activity, which helps break down certain medicines; or known IgE allergy antibodies to alpha-gal, a sugar.
  • Finished chemotherapy with radiation, or treatment before or after the main cancer treatment, less than 6 months before joining.
  • Are pregnant, breastfeeding, or plan to become pregnant during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (9)

AL

CA

FL

MA

NJ

TX

VA

WI