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NCT07814417

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

StatusNot Yet Recruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below.

  1. Trial sites expanded: 0 → 18 locations
  2. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timeframe: Baseline until Disease Progression (PD) or Participant Stops Study (Estimated up to 15 Months)
Progression-Free Survival (PFS) Per RECIST v1.1
Timeframe: Baseline to the Date of First Documented Progression of Disease or Participant Stops Study (Estimated up to 21 Months)

Secondary (5)

Overall Survival (OS)
Duration of Response (DoR)
Disease Control Rate (DCR)
Time to Response (TTR)
Pharmacokinetics (PK): Plasma Concentrations of Olomorasib (LY3537982)

Arms and interventions

Olomorasib + Cetuximab + mFOLFOX6Experimental

Olomorasib administered orally; Cetuximab, fluorouracil, leucovorin \& oxaliplatin administered intravenously (IV)

Drugs: Olomorasib, Cetuximab, Oxaliplatin, Leucovorin/levofolinate calcium, 5-fluorouracil

Sites

18 sites in 3 countries

United States 9, Spain 8, China 1