Overview

TUSC2-nanoparticles (GXP-001) in Combination With Pembrolizumab in Previously Treated Non-small Lung Cancer

Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this randomized study is to determine the safety and efficacy of GPX-001 a.k.a REQORSA ( a TUSC2, tumor suppressor gene, encapsulated by non-viral lipid nanoparticles) in combination with pembrolizumab in patients with previously treated NSCLC. The study will be conducted in 2 phases, a Dose Escalation Phase (Phase 1) and an Expansion Phase (Phase 2). In Phase 1, patients will be enrolled in sequential cohorts treated with successively higher doses of GXP-001 in combination with pembrolizumab. In Phase 2, patients will be randomized to receive GXP-001 with pembrolizumab or docetaxel +/- ramucirumab (active comparator).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Genprex, Inc.
Treatments:
Docetaxel
Pembrolizumab
Ramucirumab