Transcenta Holding Limited (HKG: 6628), a China-based biopharmaceutical company, has announced the completion of enrollment in two patient cohorts for its Phase II study of osemitamab (TST001), a CLDN18.2-targeted monoclonal antibody. The study, known as Transtar-102 (NCT04495296), focuses on patients with CLDN18.2 expressing gastric/gastro-esophageal junction (G/GEJ) adenocarcinoma in China. A pivotal Phase III study is anticipated to start later this year.
Transtar-102 Study Details and Enrollment
The Transtar-102 study is an ongoing Phase I/II, open-label, multi-cohort, multi-center clinical trial in China designed to evaluate the safety, tolerability, and efficacy of osemitamab (TST001) as a single agent or in combination with other treatments for various indications. Cohort G has enrolled a total of 82 patients with 1L non-resectable locally advanced or metastatic G/GEJ adenocarcinoma, with different levels of CLDN18.2 expression. They are treated with osemitamab (TST001) at doses of 3 or 6 mg/kg Q3W in combination with nivolumab plus CAPOX. Preliminary data indicate no unexpected safety findings, though efficacy data is not yet mature. Cohort C, which evaluates osemitamab (TST001) in combination with CAPOX as a 1L treatment for non-resectable locally advanced and metastatic G/GEJ cancer, completed enrollment by the end of 2022.
Osemitamab’s (TST001) Mechanism of Action and Previous Designations
Osemitamab (TST001) is a high-affinity humanized monoclonal antibody against CLDN18.2, with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities. It has demonstrated potent anti-tumor activities in tumor xenograft models. The drug has previously received orphan drug designations (ODDs) for use in gastric cancer/GEJ and pancreatic cancer in the United States, highlighting its potential as a treatment for these conditions.-Fineline Info & Tech
