Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GEN-001 · 2 trials · 6 indications
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Assessed as per CTCAE v5.0
Assessed as per CTCAE v5.0
To evaluate the safety and tolerability of GEN-001 in combination with avelumab
Confirmed OR per RECIST v1.1 by the Investigator
| 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...
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GEN-001 is an investigational live biotherapeutic product being studied in oncology. It is being evaluated in combination with avelumab for patients with solid tumors who have progressed on anti-PD-(L)1 therapy, and for patients with PD-L1 positive gastric cancer and gastroesophageal junction adenocarcinoma.
GEN-001 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The drug is a small molecule modality in the oncology therapeutic area.
GEN-001 is in Phase 2 clinical development. It has completed a Phase 1 trial and a Phase 2 trial, both of which are listed as completed. The drug remains investigational and has not been approved.
GEN-001 has been studied in two completed trials. NCT04601402 was a Phase 1 study of GEN-001 with avelumab in solid tumors, non small cell lung cancer, squamous cell carcinoma of the head and neck, and urothelial carcinoma. NCT05419362 was a Phase 2 study in gastric cancer and gastroesophageal junction adenocarcinoma.
Yes, GEN-001 is being studied in biomarker-selected patients. The Phase 2 trial NCT05419362 enrolled patients with PD-L1 positive gastric cancer, indicating that biomarker selection is part of the development strategy.
GEN-001 has completed two clinical trials with a total enrollment of 42 patients across both studies. The Phase 1 trial enrolled 11 patients, and the Phase 2 trial enrolled 42 patients. Both trials were uncontrolled and not randomized or double-blinded.