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.
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.
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.
Parallel
Subcutaneous Tislelizumab
DrugAdministered by subcutaneous injection
Intravenous Tislelizumab
DrugAdministered by intravenous infusion
Cisplatin
DrugAdministered by intravenous infusion
Leucovorin
DrugAdministered by intravenous infusion
5-fluorouracil (5-FU)
DrugAdministered by intravenous infusion
Oxaliplatin
DrugAdministered by intravenous infusion
Capecitabine
DrugAdministered orally
Model-Predicted Steady State Trough Concentration (Ctrough) of Tislelizumab
Model-Predicted Area under the Concentration-time Curve from Time Zero to 21 Days (AUC0-21d) after the First Dose of Tislelizumab
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Progression-Free Survival (PFS)
PFS is defined as the time from randomization date until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1
Duration of Response (DOR)
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as assessed by the investigator using RECIST v1.1
Disease Control Rate (DCR)
DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as assessed by the investigator using RECIST v1.1
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