08:00 AM EDT, 03/21/2024 (MT Newswires) -- Theratechnologies Inc. ( THTX ) on Thursday said it is moving to the next dose level in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer. The study's Medical Review Committee (MRC) has deemed the dose level in the first cohort of patients safe and has approved initiation of the next cohort with a higher dose, in accordance with the updated dose optimization protocol. Study centers are now actively recruiting patients for the second cohort, with one patient already enrolled and treated with the higher dose.
Part 3 of the Phase 1 study is intended to assess the optimal dose and schedule of sudocetaxel zendusortide, which is being administered on three consecutive weeks followed by one week of rest on Days 1, 8, and 15 of each 28-day cycle. The dose for the initial six patients was 1.75 mg/kg/dose and the dose for the next cohort of patients is 2.50 mg/kg/dose.
Theratechnologies ( THTX ) completed enrollment of the first cohort of six patients in Part 3 of the Phase 1 trial in February 2024, and dosed the first patient in October 2023.