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
← catalyst calendarNCT07043400 · readout in 436 d
Sponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
351estimated
Sites
95
Countries
Argentina, Austria, Brazil +13
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-27 | actual | When the study began enrolling |
| Primary completion | 2027-10-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-04-22 | estimated | The whole study's end, after follow-up |
| First posted | 2025-06-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Metastatic Gastric Adenocarcinoma
- Gastroesophageal Junction Adenocarcinoma
Interventions
- Drug: Subcutaneous Tislelizumab — also filed as BGB-A317
- Drug: Intravenous Tislelizumab — also filed as BGB-A317, TEVIMBRA®
- Drug: Cisplatin
- Drug: Leucovorin
- Drug: 5-fluorouracil (5-FU)
- Drug: Oxaliplatin
- Drug: Capecitabine
Primary outcomes
what the primary-completion date above is the date OFModel-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab
measured 85 Days
Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab
measured 21 Days
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