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NCT05062980 · ClinicalTrials.gov registry record · Phase 1
Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer
A Phase 1 study, sponsored by Genprex.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT05062980 is a Phase 1 study that was terminated before completion, run by Genprex. The registered enrollment target is 5 participants.
The verdict
NCT05062980, a Phase 1 study, was terminated before completion, sponsored by Genprex.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of quaratusugene ozeplasmid (Reqorsa), in combination with pembrolizumab in patients with previously treated NSCLC. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene, and is a systemic gene therapy. The study will be conducted in 2 phases, a dose escalation phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2). In Phase 1, patients will be enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with pembrolizumab to determine the recommended Phase 2 dose (RP2D). Phase 2 will be comprised of a dose expansion portion and a randomized portion. In the dose expansion portion, patients will be enrolled and treated with quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab. In the randomized portion, patients will be randomized to receive either the investigational treatment of quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab or a control treatment of either docetaxel +/- ramucirumab or the investigator's treatment of choice. Due to slow enrollment, the Accliam-2 trial was closed in Phase 1 and Phase 2 was not conducted.
Interventions
- DRUG pembrolizumab
- BIOLOGICAL quaratusugene ozeplasmid
- DRUG docetaxel
- DRUG ramucirumab
- DRUG Investigator's Treatment of Choice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-03-30 |
| Est. Completion | 2025-02-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05062980
The ClinicalTrials.gov registry entry for NCT05062980 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genprex, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which pembrolizumab is the first listed.
NCT05062980 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05062980 about?
NCT05062980 is a clinical study titled "Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer". The purpose of this study is to determine the safety and efficacy of quaratusugene ozeplasmid (Reqorsa), in combination with pembrolizumab in patients with previously treated NSCLC. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor...
What is the current status of trial NCT05062980?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2022-03-30. Estimated completion is 2025-02-03.
What interventions are being tested in trial NCT05062980?
The interventions under investigation include: pembrolizumab (DRUG), quaratusugene ozeplasmid (BIOLOGICAL), docetaxel (DRUG), ramucirumab (DRUG), Investigator's Treatment of Choice (DRUG).
Who is sponsoring clinical trial NCT05062980?
This trial is sponsored by Genprex, which has 4 total clinical trials registered on ClinicalTrials.gov.
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