Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 1 study, sponsored by Genprex.
NCT05062980 is a Phase 1 study that was terminated before completion, run by Genprex. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
RP2D which will be the MTD or if the MTD is not defined by the safety data, the RP2D will be determined based on an integrated assessment of all available clinical safety, PK, and preliminary efficacy data.
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 |
Why NCT05062980 stopped before completion
NCT05062980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which pembrolizumab is the first listed.
NCT05062980 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05062980's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI