Trials / Completed
CompletedNCT05419362
GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer
A Phase II Study to Evaluate the Safety and the Efficacy of GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Genome & Company · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GEN-001 | The capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10\^11 colony-forming units (CFU) |
| DRUG | Avelumab | 800 mg given by intravenous (IV) infusion once every 2 weeks |
Timeline
- Start date
- 2022-04-07
- Primary completion
- 2024-08-26
- Completion
- 2024-08-26
- First posted
- 2022-06-15
- Last updated
- 2025-12-16
Locations
5 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05419362. Inclusion in this directory is not an endorsement.