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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |