Clinical Trial

A Phase I Comparative Study of Pharmacokinetics, Safety, and Efficacy of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma

Completed Phase 1
View on ClinicalTrials.gov →
Summary
The primary objective of this clinical study is to compare the pharmacokinetic parameters of drugs RPH-002 and Erbitux® after a single intravenous administration, as well as to evaluate the safety of drug RPH-002 in comparison with drug Erbitux® when used in combination with Docetaxel and Cisplatin as first-line therapy in patients with Recurrent Head and Neck Squamous Cell Carcinoma. In addition, this study will include a comparative assessment of immunogenicity and a pilot evaluation of efficacy
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-20.
Trial Details
NCT Number NCT07435311
Lead Sponsor R-Pharm
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 118 participants
Start Date 2020-06-15
Primary Completion 2024-07-17 (estimated)
Study Completion 2024-07-17 (estimated)
Updated on ClinicalTrials.gov 2026-07-14