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.
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions! Learn More!