Calendario›GNPX›quaratusugene ozeplasmid · Acclaim-2

quaratusugene ozeplasmid · Acclaim-2

Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer

Ensayo de Genprex, Inc. en Cancer de pulmon no microcitico.

Más ensayos de: Cáncer de pulmón no microcítico.

Fase

Fase 1

Estado

Interrumpido

Participantes

5

previstos

Centros

6

Fin del objetivo primario

feb 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2022.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Enrollment was slow, due to competition with the many other clinical trials for the same patient population, which led to the decision to end enrollment in the trial.».

Qué mide

Recommended Phase 2 Dose (RP2D) - Phase 1 (First 21-days at each dose level) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de GNPX

Todos los de GNPX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05062980), actualizada en may 2026.