Study of TST001 Monoclonal Antibody for Safety and Early Effectiveness in Advanced or Metastatic Solid Tumors Including Gastric and Biliary Cancers

What this Trial Is About

Researchers are evaluating TST001, a Claudin18.2 monoclonal antibody, in an open-label, multi-center Phase IIIa trial for adults with locally advanced or metastatic solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of TST001 alone and in combination with other therapies in cancers such as gastric, gastroesophageal junction, biliary tract, pancreatic, lung adenocarcinoma, and colorectal cancer. This trial is sponsored by Suzhou Transcenta Therapeutics Co., Ltd. The trial consists of two parts Part I involves dose escalation and expansion of TST001 as a mono-therapy administered intravenously every 2 or 3 weeks using a 33 design to determine the recommended dose. Part II evaluates TST001 in combination with other drugs like Oxaliplatin, Capecitabine, Paclitaxel, Gemcitabine, Cisplatin, and Nivolumab in similar dose escalation and expansion phases. Multiple cohorts target different cancer types and treatment histories, with about 320 to 540 participants expected in total. Participants will receive scheduled intravenous doses of TST001 or combination therapies, and researchers will monitor safety by tracking adverse events, dose-limiting toxicities, and lab tests up to 30 to 90 days after treatment. Pharmacokinetics and immune responses will be measured through blood samples. Tumor response, disease control, progression-free survival, and overall survival will be evaluated. The study includes follow-up for up to 30 days after the last dose and requires participants to meet specific health and lab criteria before enrollment.

A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors