Phase IbII Study of Neoadjuvant Zolbetuximab With Docetaxel, Oxaliplatin, and S-1 Chemotherapy in Adults With Locally Advanced Gastric Cancer

What this Trial Is About

Gastric cancer remains a leading cause of cancer-related death worldwide, with many patients experiencing recurrence after surgery. Researchers are investigating the effectiveness and safety of adding zolbetuximab, a monoclonal antibody targeting Claudin 18.2, to chemotherapy as a neoadjuvant treatment for patients with locally advanced gastric cancer LAGC. Claudin 18.2 is overexpressed in a significant portion of these tumors, making it a promising target for therapy. This Phase IbII open-label study evaluates zolbetuximab combined with docetaxel, oxaliplatin, and S-1 chemotherapy given before surgery. Patients receive three cycles of this neoadjuvant treatment every three weeks, followed by surgical removal of the stomach tumor and lymph node dissection. After surgery, patients receive adjuvant therapy with S-1 and zolbetuximab for up to 12 months to further treat the cancer. Participants will undergo regular assessments including surgery outcomes, tumor response, and survival measures. The main outcomes include the rate of complete tumor removal R0 resection and determination of the recommended dose of zolbetuximab. Safety will also be monitored throughout the study. The total participation time includes pre-surgery treatment, surgery, and up to a year of post-surgery therapy, with follow-up evaluations to assess treatment effects and patient health.

A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer