Handok submitted an IND (Investigational New Drug) application for a domestic Phase 2/3 clinical trial for HDB001A, used in the treatment of people with biliary tract cancer, to the Ministry of Food, Drug, and Safety (MFDS) on March 20, 2023.

Handok is currently collaborating with United States-based biotech Compass Therapeutics on the development of HDB001A for biliary tract cancer. With this IND filing, the global Phase 2/3 clinical trial with Compass Therapeutics will be initiated in Korea, which will provide additional data on the efficacy and safety of HDB001A in a larger number of biliary tract cancer patients following the ongoing Phase 2 clinical trial in Korea. The global Phase 2/3 study of HDB001A, to be conducted at more than 20 sites across the world, including South Korea, will be a randomized, controlled trial of HDB001A “in combination with paclitaxel” versus “independent administration of paclitaxel” in adult patients with unresectable advanced, metastatic, or recurrent biliary tract cancer who have already undergone one prior systemic chemotherapy regimen.