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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 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 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04601402
The ClinicalTrials.gov registry entry for NCT04601402 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Genome & Company, which has 1 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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