Phase 3 Study of Subcutaneous vs. Intravenous Tislelizumab Plus Chemotherapy in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- Trial ID
- 2025-522862-58-00
- Protocol
- BGB-A317-316
- Sponsor
- BeOne Medicines AG
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to demonstrate the pharmacokinetic noninferiority of tislelizumab administered via subcutaneous injection compared to intravenous infusion in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. 6
The secondary objectives include:
- Evaluation of efficacy (5)
- Assessment of the safety and tolerability profile (4)
- Comparison of pharmacokinetics between administration routes (6)
- Comparison of immunogenicity (4)
Participants
This study involves a total of 288 patients diagnosed with gastric or gastroesophageal junction adenocarcinoma that is either locally advanced unresectable or metastatic. The study population includes both males and females within specific age ranges. Eligible participants must have a histologically confirmed diagnosis and have received no prior systemic therapy for their condition. Additional requirements include the presence of at least one measurable or nonmeasurable lesion per RECIST v1.1 and the ability to provide tumor tissues for biomarker assessment. Participants must possess an Eastern Cooperative Oncology Group performance status of 1 or less and demonstrate adequate organ function. Requirements regarding birth control methods are specified for both women of childbearing potential and non-sterile males.
Plans and Procedures
This Phase 3, multi-center, randomized, open-label clinical study is designed to evaluate the pharmacokinetics of tislelizumab administered via subcutaneous injection compared to intravenous infusion plus chemotherapy. The investigation focuses on patients with gastric or gastroesophageal junction adenocarcinoma that is locally advanced unresectable or metastatic. The primary objective is to demonstrate noninferiority regarding the model-predicted trough serum concentration and the area under the curve. Secondary endpoints include overall response rate, progression-free survival, duration of response, disease control rate, and overall survival. Safety will be assessed through the monitoring of adverse events and the presence of antidrug antibodies. The study protocol involves a screening period to confirm histologically confirmed disease, ECOG performance status, and adequate organ function. Participants will undergo treatment and subsequent follow-up assessments to monitor clinical outcomes and safety profiles.
Treatment
The experimental treatment consists of tislelizumab 300 mg provided as a solution for injection. This medication is administered via subcutaneous injection.
The comparator treatment is Tevimbra, which is a 100 mg concentrate for solution for infusion. This substance is administered through intravenous administration at a dose of 200 mg.
Efficacy
The primary efficacy assessment focuses on pharmacokinetic noninferiority. The primary endpoints consist of the model-predicted trough serum concentration (Ctrough) at steady-state and the model-predicted AUC0-21d of Cycle 1.
Secondary efficacy parameters include:
- Overall response rate (ORR), progression-free survival (PFS), duration of response (DOR), and disease control rate (DCR), which are evaluated by the investigator using RECIST v1.1.
- Overall survival (OS).
- Model-predicted and observed Cycle 1 Ctrough, observed Cycle 1 AUC, and model-predicted AUC at steady-state (AUCss).
- The percentage of patients developing antidrug antibodies (ADAs) following subcutaneous or intravenous administration.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma.
- No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
- At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.
- Must be able to provide tumor tissues for biomarker assessment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.
- Adequate organ function.
- Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and ≥ 120 days after the last dose of tislelizumab.
- Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab.
Exclusion Criteria
- Squamous cell or undifferentiated or other histological type gastric cancer (GC).
- Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before randomization.
- Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Austria | Recruiting | 01 Dec 2025 | 6 |
 Czechia | Recruiting | 01 Dec 2025 | 12 |
 France | Recruiting | 01 Dec 2025 | 12 |
 Italy | Recruiting | 01 Dec 2025 | 12 |
 Poland | Not Yet Recruiting | 01 Dec 2025 | 10 |
 Spain | Recruiting | 01 Dec 2025 | 11 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Tevimbra 100 mg concentrate for solution for infusion | Comparator | CONCENTRATE FOR SOLUTION FOR INFUSION | INTRAVENOUS ADMINISTRATION | 200 | 24 | PRD11015696 |
Tislelizumab 300 mg solution for injection | Test | SOLUTION FOR INJECTION | SUBCUTANEOUS INJECTION | 300 | 24 | PRD11844150 |