IT-101 is a combination of Insert’s patented polymer technology, Cyclosert, and the anticancer compound camptothecin. According to the company, Cyclosert is the first nanoparticulate drug delivery platform to be designed de novo and synthesized specifically to overcome limitations in existing delivery technologies used for the systemic delivery of therapeutics.
The study is an open-label, dose-escalation phase I study in patients with inoperable or metastatic solid tumors and has been designed to evaluate the safety, tolerability and pharmacokinetics of IT-101. Insert expects that between 24 and 48 patients will be enrolled in the study during its course.
Animal studies using IT-101 showed excellent anticancer activity, including complete remission of certain kinds of lung cancer, among others. Furthermore, in these studies, treatment with IT-101 has resulted in protracted anti-tumor activities that are substantially more effective than irinotecan or camptothecin administered alone.