This open-label, randomized, multicenter, parallel group study was conducted in patients with head and neck cancer and involved several investigational sites in Russia. The trial successfully achieved the recruitment target of 100 screened and randomized subjects.
The aim of this trial was to investigate the tolerability, pharmacokinetics and pharmacodynamics of the study drug, as well as to evaluate its therapeutic efficacy and safety as compared to its reference product in patients with recurrent or metastatic squamous head and neck cancer. The investigational drug is a biosimilar monoclonal antibody product.
Currently cleaning and statistical analysis of the research data are underway.
OCT’s expertise in oncology clinical studies includes more than 50 trials of various phases. Our long-term and successful collaboration with local sites allows us to achieve high enrollment rates and high quality of clinical trials.