OCT Clinical announced the enrollment of the first patients in a phase III oncology clinical study. The sponsor is a global clinical-stage biopharmaceutical company with R&D and global clinical operations centers in China and the United States.
This is a Ph3 study in patients with recurrent or metastatic head and neck squamous cell carcinoma. The primary goal of the study is to assess the overall survival (OS) in patients with refractory, recurrent, or metastatic HNSCC.
The recruitment target set for OCT Clinical is 40 patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti-PD-1/anti-PD-L1 monotherapy, prior anti-PD-1/anti-PD-L1 therapy in combination with platinum-based therapy, or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post platinum-based therapy. Participants will be undergoing the treatment at 10 research sites.
“We are very happy that we came across OCT Clinical to take over the Eastern European part of our trials. We have been extremely impressed with the CRO’s portfolio and are counting on their professionalism and performance in helping out our patients”, — Sponsor’s Representative.
Within the project, the OCT Clinical team is responsible for feasibility analysis, logistics, medical monitoring, monitoring, project management, administrative support and accounting, quality assurance, regulatory and ethics submissions, site selection and management, training and translation.