Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05419362 | GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer | PHASE2 | COMPLETED | 42 | — | — | Apr 7, 2022 | Aug 26, 2024 | Dec 16, 2025 | 5 | South Korea |
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
| Arm | Type | Description |
|---|---|---|
| GEN-001 with avelumab | EXPERIMENTAL | 42 patients in total with metastatic GC/Gastroesophageal Junction Adenocarcinoma who have progressed after 2 prior systemic treatments and confirmed PD-L1 positive expression will be enrolled in this study. |
| Name | Type | Description |
|---|---|---|
| GEN-001 | DRUG | The capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10\^11 colony-forming units (CFU) |
| Avelumab | DRUG | 800 mg given by intravenous (IV) infusion once every 2 weeks |
Inclusion Criteria: * Histologically confirmed unresectable, recurrent, locally advanced or metastatic GC/Gastroesophageal Junction Adenocarcinoma * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have adequate organ functions as defined in the protocol * Negative childbear...