Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
notable Trial sites expanded: 86 -> 93 locations 2026-05-30
notable Trial sites expanded: 82 -> 85 locations 2026-04-23
notable Trial sites expanded: 78 -> 82 locations 2026-04-17
Trial Details
NCT Number NCT07043400
Lead Sponsor BeOne Medicines
Conditions Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Enrollment 351 participants
Start Date 2025-08-27
Primary Completion 2027-10-30 (estimated)
Study Completion 2028-04-22 (estimated)
Updated on ClinicalTrials.gov 2026-08-07