NEW YORK – Genprex on Tuesday said it has begun recruiting non-small cell lung cancer patients with EGFR-mutated tumors into a Phase I/II clinical trial where they will receive its investigational drug quaratusugene ozeplasmid (Reqorsa) in combination with osimertinib (AstraZeneca's Tagrisso).
The Acclaim-1 trial will enroll approximately 100 late-stage NSCLC patients with EGFR mutations who have previously progressed on osimertinib and evaluate the activity of quaratusugene ozeplasmid and osimertinib across 10 sites. The US Food and Drug Administration granted fast-track designation to quaratusugene ozeplasmid for this indication in January.
In the Phase I portion of the study, researchers will identify the maximum tolerated dose and measure patients' progression-free survival on the combination regimen. In the Phase II portion, they will evaluate overall response rate, overall survival, duration of treatment, and adverse events.
Last month, Genprex announced a research program in which it would evaluate quaratusugene ozeplasmid in combination with other treatments in lung cancer patients. Acclaim-1 is one study within this program. Acclaim-2 is evaluating Genprex's investigational drug with the checkpoint inhibitor pembrolizumab (Merck's Keytruda) in NSCLC patients with PD-L1 expression in 1 percent to 49 percent of tumor cells and who have low expression status.
Genprex is also studying quaratusugene ozeplasmid with erlotinib (Genentech's Tarceva) in a Phase II trial in stage IV lung cancer patients with and without EFGR mutations.