Oncoral is currently being evaluated in an ongoing investigator sponsored Phase I trial at Herlev Hospital, Denmark. The study is a dose-escalating safety, tolerability and pharmacokinetics study of orally administered Oncoral in adult patients with advanced solid tumors. The objectives of the study are to determine the safety, tolerability and maximum tolerated dose of Oncoral given as single agent and when administered in combination with the oral chemotherapeutic drug capecitabine. Additional objectives are to determine any objective tumor response or stable disease, and to describe the pharmacokinetics of Oncoral given as single agent. The first patient was enrolled in July, 2015, and a total of 25 patients have been enrolled in the part of the study with Oncoral given as single agent. The second part of the study with Oncoral given in combination with capecitabine was initiated in June 2017 and is expected to include 12 additional patients. The study is expected to be completed in 2018.
The clinical development strategy for Oncoral is to obtain Phase II data and then to partner for the further development to market. The plan is to design and conduct a Phase II study on Oncoral in combination with capecitabine and a selected targeted anti-cancer agent, in irinotecan naive, HER2 negative patients with un-resectable or metastatic gastric cancer. The choice of targeted agent will be decided based on interactions with clinical advisors and regulatory authorities. Preliminary plans for the Phase II study involve a dose-escalation part with Oncoral, capecitabine and the selected targeted agent in order to determine safety and tolerability and define doses for the extension part of the Phase II study. The extension part of the study aims at establishing proof of clinical concept based on relevant safety and efficacy parameters. Results from the ongoing investigator sponsored Phase I study (when completed) will be considered when designing the Phase II study.