Combination of TST001, Nivolumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma

• Status: Not yet recruiting
• Trial end date: 2026-01-31

Summary

Gastric/GEJ adenocarcinomas are aggressive tumors with a high probability of death. Current treatment guidelines include two-drug cytotoxic chemotherapy with a fluoropyrimidine (mFOLFOX6: capecitabine or fluorouracil) and a platinum-based agent (CapOx: oxaliplatin or cisplatin). In addition, the FDA has recently approved nivolumab, a PD-1 checkpoint inhibitor, in combination with chemotherapy as first line treatment for advanced or metastatic gastric/GEJ cancer. TST001 is a recombinant humanized monoclonal antibody against Claudin (a tumor marker found in gastric/GEJ cancer. In this study, the combination therapy of chemotherapy or chemotherapy and nivolumab with and without TST001 (a novel recombinant humanized antibody) could provide additional benefits to the management of these tumors.

• Phase: Phase 3

Details

• Lead Sponsor: Suzhou Transcenta Therapeutics Co., Ltd.
• Treatments: Capecitabine; Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Nivolumab; Oxaliplatin