NCT07043400|RecruitingPhase 3DMCFDA Drug

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

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

BeOne Medicines ClinicalTrials.gov

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2 other identifiers

BGB-A317-3162025-522862-58-00

Study Type

interventional

Target

351

Locations

15 countries

Sites

Timeline

RegisteredJun 2025

StartedAug 2025

CompletionApr 2028

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

351

participants targeted

Target at P50-P75 for phase_3

Timeline

24mo left

Started Aug 2025

Typical duration for phase_3

Geographic Reach

15 countries

85 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

Study Progress26%

Aug 2025Apr 2028

First Submitted

Initial submission to the registry

June 20, 2025

Completed

9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed

2 months until next milestone

Study Start

First participant enrolled

August 27, 2025

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2027

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

June 20, 2025

Last Update Submit

April 21, 2026

Conditions

Metastatic Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab
85 Days
Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab
21 Days

Secondary Outcomes (11)

Objective Response Rate (ORR)
Up to 2 years
Progression-Free Survival (PFS)
Up to 2 years
Duration of Response (DOR)
Up to 2 years
Disease Control Rate (DCR)
Up to 2 years
Overall Survival (OS)
Up to 2 years
+6 more secondary outcomes

Study Arms (2)

Arm A: Tislelizumab Subcutaneous + Chemotherapy

EXPERIMENTAL

Participants will receive tislelizumab 300 mg subcutaneous (SC) injection on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.

Drug: Subcutaneous TislelizumabDrug: CisplatinDrug: LeucovorinDrug: 5-fluorouracil (5-FU)Drug: OxaliplatinDrug: Capecitabine

Arm B: Tislelizumab Intravenous Infusion + Chemotherapy

ACTIVE COMPARATOR

Participants will receive tislelizumab 200 mg intravenous infusion (IV) on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.

Drug: Intravenous TislelizumabDrug: CisplatinDrug: LeucovorinDrug: 5-fluorouracil (5-FU)Drug: OxaliplatinDrug: Capecitabine