Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma
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 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 18.2 (a tumor marker found in gastric/GEJ cancer. In this study, the combination therapy of chemotherapy or chemotherapy and pembrolizumab with and without TST001 could provide additional benefits to the management of these tumors.
Timeline
- Start
- 2026-06-30
- Primary completion
- 2029-10-01
- Completion
- 2030-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Osemitamab | Monoclonal antibody | — | Intravenous |
| Comparator | Capecitabine | Small molecule | — | — |
| Comparator | Leucovorin | Small molecule | — | — |
| Comparator | Oxaliplatin | Small molecule | — | — |
| Comparator | Pembrolizumab | Monoclonal antibody | — | — |
| Comparator | fluorouracil | Small molecule | — | — |