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NOT YET RECRUITING
NCT07814417
PHASE2

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-10

Completion Date

2028-11

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DRUG

Olomorasib

Administered orally

DRUG

Cetuximab

Administered IV

DRUG

Oxaliplatin

Administered IV

DRUG

Leucovorin/levofolinate calcium

Administered IV

DRUG

5-fluorouracil

Administered IV

Locations (18)

University of Alabama at Birmingham

Birmingham, Alabama, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

AdventHealth Orlando

Orlando, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

START Astera, LLC

East Brunswick, New Jersey, United States

Texas Oncology - Central South

Austin, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Inova Health Care Services

Falls Church, Virginia, United States

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin, United States

Beijing Cancer hospital

Beijing, China

Hospital del Mar

Barcelona, Spain

Hospital Universitari Quiron Dexeus Barcelona

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Complejo hospitalario de Jaen

Jaén, Spain

Clinica Universidad de Navarra - Madrid

Madrid, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Hospital Universitario Marques De Valdecilla

Santander, Spain

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Spain