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Clinical Trial 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).

Clinical Trial Description

ONC-004 is a multi-center, open-label 2-arm study of GPX-001 in combination with pembrolizumab versus docetaxel +/- ramucirumab (active comparator) in previously treated NSCLC with any PD-L1 TPS and NOT considered refractory to pembrolizumab, as defined by having achieved at least a 3-month clinical benefit to previous pembrolizumab-containing treatment. The total duration of study for each patient will be dependent upon the safety, tolerability, and efficacy of the combination regimen of GPX-001 and pembrolizumab. The Phase 1 portion of the study will involve a 3+3 dose escalation schema of GPX-001 up to 0.12 mg/kg in combination with a fixed dose of pembrolizumab (200 mg) administered once via intravenous (IV) infusion during each 21-day treatment cycle. Three GPX-001 doses will be tested (0.06, 0.09 and 0.12 mg/kg administered on Day 1 of a 21-day treatment cycle). The Phase 2 portion of the study is a randomized, open-label 2-arm study of GPX-001 in combination with pembrolizumab versus docetaxel ± ramucirumab. In Phase 2, 126 patients will be randomized 2:1 to the combination versus active comparator treatment arms, respectively. The 84 patients randomized to the combination arm will receive GPX-001, at the RP2D identified in Phase 1, in combination with 200 mg pembrolizumab either during each 21-day cycle until disease progression or unacceptable toxicity as determined by the investigator. The 42 patients randomized to the active comparator arm will receive docetaxel at the FDA-approved dose of 75 mg/m2 every 21 days until disease progression or unacceptable toxicity as determined by the investigator. Investigators are permitted to administer docetaxel in combination with ramucirumab at their discretion. All patients will be assessed radiologically for tumor response until disease progression according to RECIST 1.1 criteria approximately every 6-8 weeks. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05062980
Study type Interventional
Source Genprex, Inc.
Contact Shannon Inman
Phone 1-877-774-GNPX
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date December 2021
Completion date December 2025

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