This is a single-site, single-blind, placebo-controlled, randomized study assessing the safety, tolerability and pharmacodynamics of the study drug affecting the intensity of the immune response of tumor cells in patients with colon cancer. The study drug contains a newly developed innovative molecule. This phase II clinical trial is a pilot study both in Russia and in all over the world.
One of important aspects of tumor pathogenesis is a low immune response in tumor and in surrounding intact cells. The study drug is a specific agent which stimulates the immune response mechanism. It has demonstrated antitumor effects inhibiting the growth and progression of tumors of similar types but different anatomic locations. Current pre-clinical data suggest that the drug may be most effective in patients with colorectal cancer, as it may increase tumor resectability and decrease the risk of dissemination of tumor cells in patients undergoing surgery.
For this study, more than 30 subjects are expected to be enrolled who will receive different doses of the study drug. The study period will last approximately 1.5 months. The main part of the study will be followed by a subsequent part which will last approximately 12 months. During this period the subjects will have CT and MRI examinations.
OCT will provide the following scope of services for this project: project management, clinical monitoring, data management, statistical analysis and final report preparation. OCT has a strong clinical oncology experience, as well as in-depth expertise in clinical trials of various phases and therapeutic areas. Our long-term collaboration with various investigational sites allows us to successfully conduct and complete clinical trials.