T-1101, oral powder for constitution (OPC), from Taivex has completed the phase I trial in Oct, 2019. Total 21 patients have received T-1101 (Tosylate) OPC treatment in 4 clinical trial centers.
According to the Phase clinical data, T-1101 has initially proved its safety and efficacy. Taivex will continue the development of T-1101 to further clinical trial with oral capsule form that is convenient to store and with good patient compliance for market.
T-1101 OPC clinical trial: T-1101 was initially formulated as an exploratory oral powder in bottles for constitution (OPC) and supplied for the treatment of patients with advanced refractory solid tumors in 2 open-label, phase 1 studies (TAI-001 & TAI-002). TAI-001 is the first-in-human, dose-escalation study which is standard 3+3 dose escalation design with QD in a 21-day cycle (14 consecutive days of treatment followed by 7 days or rest) for 2 cycles.
TAI-002 is the extension program and patients allowed to enter the extension study (TAI-002) should the investigator and/or sponsor expect the patient to continue to have an overall positive benefit/risk ratio from continuing treatment.