Following IND approval by the US FDA in Mid-January, 2021, Taivex submitted the Phase I clinical trial application to the Taiwan FDA later on January 29 and received approval on April 12. The anticipated initiation of the Phase I trial remains by middle of 2021.
T-1201 Phase I trial is a multi-centered study in Taiwan, will enroll advanced solid tumor subject. The objective of this study was to determine the maximum tolerable dose in human and the preliminary effect.