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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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This is a phase II, multicenter, open-label study to evaluate the antitumor activity, efficacy and safety of GEN-001 in combination with avelumab as a third line (3L) or greater line treatment which is not received the Standard of Care (SOC) for patients with PD-L1 positive advanced GC/Gastroesophageal Junction Adenocarcinoma who are not received cancer immunotherapy regimens as mono or combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEN-001 | Drug | The capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10^11 colony-forming units (CFU) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab | Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Assessed as per CTCAE v5.0 | 1 years |
| Incidence of Laboratory abnormalities | Assessed as per CTCAE v5.0 | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota | fecal samples will be collected for analysis | 1 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeeyun Lee | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Gyeonggi-do | South Korea | ||||
| Seoul National University Bundang Hospital |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000609138 | avelumab |
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| Avelumab | Drug | 800 mg given by intravenous (IV) infusion once every 2 weeks |
|
|
| Duration of response (DoR) | Assessed according to RECIST v1.1 | 1 years |
| Progression-free Survival (PFS) | Assessed according to RECIST v1.1 | 1 years |
| Overall Survival (OS) | 1 years |
| Gyeonggi-do |
| South Korea |
| Asan Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |