Transcenta Holding has received FDA clearance to proceed with the TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as a first-line treatment for patients with HER2-negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma.
Osemitamab (TST001) is a second-generation humanised antibody designed to target CLDN18.2 with improved binding affinity and enhanced antibody-dependant cellular cytotoxicity (ADCC). It has demonstrated anti-tumour activity in preclinical models with a wide range of CLDN18.2 expression levels.
The goal of this Phase III trial is to evaluate the efficacy and safety of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as a first-line treatment for HER2-negative G/GEJ adenocarcinoma. This combination therapy approach, specifically targeting CLDN18.2, has the potential to redefine the treatment approach for G/GEJ cancer.
Phase II clinical trials were conducted in both the U.S. and China to support the global Phase III trial application and the FDA End-of-Phase 2 (EOP2) meeting. These Phase II trials included various dosing cohorts of Osemitamab (TST001) in combination with chemotherapy or Nivolumab and chemotherapy to determine the optimal dose for the upcoming Phase III trial.
