MSI-H/dMMR Gastric cancer, MSI-H/dMMR Gastroesophageal-junction Cancer
Conditions
Brief summary
Phase 1b and Phase 2: Incidence of dose-limiting toxicities (DLTs)., Phase 1b and Phase 2: Frequency and severity of adverse events (AEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)., Phase 1b and Phase 2: Incidence of AEs leading to dose interruption, modification, delays and permanent treatment discontinuation., Phase 1b and Phase 2: Change from baseline to the end of the study in safety laboratory values and vital signs., Phase 2: Objective response (OR) per investigator assessment using RECIST v1.1.
Detailed description
Phase 1b: Objective response (OR), duration of response (DoR), progression-free survival (PFS), and disease control (DC) according to RECIST v1.1 and iRECIST as assessed by investigator., Phase 1b and Phase 2: Overall survival (OS) per investigator assessment., Phase 1b and Phase 2: Serum concentrations of S095029, Phase 1b and Phase 2: Concentration of potential antibodies directed against S095029., Phase 2: DoR, PFS, and DC according to RECIST v1.1 as assessed by investigator., Phase 2: OR, DoR, PFS, and DC according to iRECIST criteria as per investigator assessment.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1b and Phase 2: Incidence of dose-limiting toxicities (DLTs)., Phase 1b and Phase 2: Frequency and severity of adverse events (AEs) and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)., Phase 1b and Phase 2: Incidence of AEs leading to dose interruption, modification, delays and permanent treatment discontinuation., Phase 1b and Phase 2: Change from baseline to the end of the study in safety laboratory values and vital signs., Phase 2: Objective response (OR) per investigator assessment using RECIST v1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1b: Objective response (OR), duration of response (DoR), progression-free survival (PFS), and disease control (DC) according to RECIST v1.1 and iRECIST as assessed by investigator., Phase 1b and Phase 2: Overall survival (OS) per investigator assessment., Phase 1b and Phase 2: Serum concentrations of S095029, Phase 1b and Phase 2: Concentration of potential antibodies directed against S095029., Phase 2: DoR, PFS, and DC according to RECIST v1.1 as assessed by investigator., Phase 2: OR, DoR, PFS, and DC according to iRECIST criteria as per investigator assessment. | — |
Countries
Austria, Belgium, Denmark, France, Hungary, Italy, Spain