drugset / Trial / NCT07043400
A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.
Timeline
- Start
- 2025-08-27
- Primary completion
- 2027-10-30
- Completion
- 2028-04-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Subcutaneous |
| Subject | Tislelizumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Background | Capecitabine | Small molecule | — | Oral |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | Oxaliplatin | Small molecule | — | Intravenous |
| Background | fluorouracil | Small molecule | — | Intravenous |