Pharma Focus Asia

Transcenta Holding Receives FDA Clearance to Proceed with Global Phase III Trial of Osemitamab

Wednesday, October 04, 2023

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.

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