GCT has been awarded a new Phase I clinical trial in patients with breast cancer. It aims to prove the safety, tolerance and pharmacokinetics of the Investigated Medical Product (IMP) using the dose escalation method. The study will be conducted in Russia with enrolling 60 patients who suffer from palindromic or refractory metastatic breast cancer. The project is sponsored by a Russian biotechnology start-up company specializing in oncology research.
The clinical trial is now in the active start-up process, and the regulatory submission is expected in early September. Global Clinical Trials is currently in the process of performing medical and regulatory review of documents prior to the RA submission. GCT monitors will soon be performing Pre-Study site visits (PSVs).