A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination with Pembrolizumab versus Docetaxel with or without Ramucirumab in Patients with Previously Treated Non-Small Cell Lung Cancer (Acclaim 2)
The purpose of this randomized study is to determine the safety and efficacy of Reqorsa (quaratusugene ozeplasmid, formerly known as GPX-001), in combination with pembrolizumab in patients with previously treated NSCLC. Reqorsa consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene, and is the first systemic gene therapy.
Primary Objectives Phase 1: Identify maximum tolerated dose (MTD) of GPX-001 when given in combination with pembrolizumab and to evaluate the safety profile of this combination. Phase 2: Compare progression-free survival (PFS) of the GPX-001 plus pembrolizumab combination versus active comparator. Secondary Objectives Phase 2: Determine whether overall survival (OS) of GPX-001 in combination with pembrolizumab prolongs patient survival compared to active comparator. Evaluate the tolerability and toxicity of GPX-001 in combination with pembrolizumab.
Chemotherapy (NOS); Immunotherapy
GPX-001 (); IMC-1121B (Ramucirumab); Pembrolizumab (Keytruda); Ramucirumab (); Taxotere (docetaxel); docetaxel ()
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