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NCT04601402 · ClinicalTrials.gov registry record · Phase 1
GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy
A Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, sponsored by Genome & Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 3
- Study locations
NCT04601402: Completed Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, sponsored by Genome & Company.
NCT04601402 is a Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor that has completed, run by Genome & Company. The registered enrollment target is 11 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04601402, a Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, has completed, sponsored by Genome & Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination), when administered as combined with avelumab.
Primary Outcome
Assessed as per CTCAE v5.0
Conditions Studied
Interventions
- DRUG Avelumab
- DRUG GEN-001
Study Locations (3)
Connecticut
- Yale Cancer Center - New Haven
Georgia
- Emory University Winship Cancer Institute - Atlanta
Oregon
- Oregon Health & Science University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2023-01-11 |
| Phase | Phase 1 |
What the finished NCT04601402 record still lists
NCT04601402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Avelumab is the first listed.
NCT04601402 reports a single indexed study location in Connecticut, Georgia, Oregon.
Frequently Asked Questions
What is clinical trial NCT04601402 about?
NCT04601402 is a clinical study titled "GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy". This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved t...
What is the current status of trial NCT04601402?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2020-10-26. Estimated completion is 2023-01-11.
What conditions does trial NCT04601402 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Solid Tumor, Urothelial Carcinoma, Squamous Cell Carcinoma of Head and Neck.
What interventions are being tested in trial NCT04601402?
The interventions under investigation include: Avelumab (DRUG), GEN-001 (DRUG).
Who is sponsoring clinical trial NCT04601402?
This trial is sponsored by Genome & Company, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04601402 being conducted?
This trial has 3 study locations across Connecticut, Georgia, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04601402's enrollment target sits among peer trials
11 444th of 454 higher than 10 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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