A Study to Investigate Tislelizumab Administered as Sub C Injection Versus IV BGB A317-316
Research type
Research Study
Full title
A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
IRAS ID
1012522
Contact name
Camilla Massoudi
Contact email
Sponsor organisation
BeOne Medicines I GmbH
Eudract number
2025-522862-58
Clinicaltrials.gov Identifier
Research summary
This is a randomized, open-label, Phase 3 study designed to demonstrate the noninferiority of drug exposure following treatment with tislelizumab administered as subcutaneous injection (SC) versus intravenous (IV) infusion for locally advanced unresectable or metastatic gastric or Gastroesophageal Junction adenocarcinoma. Approximately 351 participants are planned to be recruited; eligible participants will be randomised in a 2:1 ratio to receive either tislelizumab SC injection plus chemotherapy (Arm A) or tislelizumab IV infusion plus chemotherapy (Arm B). The enrolled participants will be stratified based on various factors at randomisation including PD-L1 expression, presence of peritoneal metastasis and Investigator’s choice of chemotherapy (oxaliplatin + 5-FU +leucovorin versus oxaliplatin + capecitabine versus cisplatin +5-FU). Participants will be treated initially for 12 to 24 weeks, after which maintenance tislelizumab SC/IV plus optional capecitabine or 5-FU at the dose per local standard of practice.
Tislelizumab given in combination with chemotherapy is well tolerated and the safety profile is consistent with that of other PD-1 inhibitors given in combination with chemotherapy.
SC delivery is a valuable alternative to IV administration across many disease areas. SC administration has been proven to be effective, safe, well tolerated, generally preferred by patients and healthcare professionals, as well as reduced drug delivery-related costs and resource use. A SC concentrated formulation of tislelizumab will improve treatment options, add more flexibility for combination treatments, and reduce burden and increase efficiency for patients and practitioners. It also may become a valuable option for patients with fluid restrictions or difficult venous access.
The maximum length of receiving study drug(s) for a participant is up to 2 years, with the total duration of this study is estimated to be approximately 3 years.REC name
Wales REC 1
REC reference
25/WA/0217
Date of REC Opinion
5 Sep 2025
REC opinion
Further Information Favourable Opinion