drugset / Trial / NCT07435324
A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study is to evaluate the comparability of efficacy, safety, and immunogenicity of RPH-002 and Erbitux® when administered in combination with docetaxel and cisplatin as first-line therapy in patients with advanced head and neck squamous cell carcinoma
Timeline
- Start
- 2024-08-08
- Primary completion
- 2025-09-16
- Completion
- 2026-06-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |