Locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
Conditions
Brief summary
Model-predicted trough serum concentration (Ctrough) at steady-state (predose C5D1) and model-predicted AUC0-21d of Cycle 1
Detailed description
Overall response rate (ORR), progression-free survival (PFS), duration of response (DOR), and disease control rate (DCR) each assessed by investigator per RECIST v1.1, and overall survival (OS), Adverse events (AE) and serious adverse events (SAE) as characterized by type, frequency, severity (NCI-CTCAE v5.0), timing, seriousness, and relationship to study treatment, Model-predicted and observed Cycle 1 Ctrough, observed Cycle 1 AUC, and model-predicted AUC at steady-state (AUCss), Percentage of patients with antidrug antibodies (ADAs) to tislelizumab after subcutaneous (SC) or intravenous (IV) administration
Interventions
DRUGTislelizumab 300 mg solution for injection
Sponsors
BeOne Medicines AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Model-predicted trough serum concentration (Ctrough) at steady-state (predose C5D1) and model-predicted AUC0-21d of Cycle 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR), progression-free survival (PFS), duration of response (DOR), and disease control rate (DCR) each assessed by investigator per RECIST v1.1, and overall survival (OS), Adverse events (AE) and serious adverse events (SAE) as characterized by type, frequency, severity (NCI-CTCAE v5.0), timing, seriousness, and relationship to study treatment, Model-predicted and observed Cycle 1 Ctrough, observed Cycle 1 AUC, and model-predicted AUC at steady-state (AUCss), Percentage of patients with antidrug antibodies (ADAs) to tislelizumab after subcutaneous (SC) or intravenous (IV) administration | — |
Countries
Austria, Czechia, France, Italy, Poland, Spain
Outcome results
None listed