drugset / Trial / NCT05775900

Efficacy and Safety of Triweekly Cetuximab in Combination With Capecitabine as First-line Maintenance Treatment for KRAS/BRAF Wild-type Metastatic Colorectal Cancer

NCT05775900

Phase 1/2 Completed 24 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

To explore the safety, efficacy and pharmacokinetic (PK) characteristics of triweekly cetuximab in combination with capecitabine as first-line maintenance treatment for KRAS/BRAF wild-type metastatic colorectal cancer: a single-arm, a single-center, Phase 1b trial. Meanwhile, Exploring the maximum tolerant dose or recommended II research dose of triweekly cetuximab combined with a fixed dose of capecitabine using '3+3' dose climbing Phase I experiment.

Timeline

Start
2023-02-01
Primary completion
2025-07-31
Completion
2025-08-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Cetuximab Monoclonal antibody 400 mg/m2
Subject Cetuximab Monoclonal antibody 500 mg/m2
Subject Cetuximab Monoclonal antibody 600 mg/m2
Subject Cetuximab Monoclonal antibody 700 mg/m2

Indications