Genprex ( NASDAQ: GNPX ) said a Safety Review Committee (SRC) approved continuation to the third and final group in the dose escalation phase 1 part of a phase 1/2 trial.
The study, dubbed Acclaim-1, is evaluating Reqorsa in combination with in combination with AstraZeneca's Tagrisso (osimertinib) to treat patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso (osimertinib).
"The SRC's recommendation to increase the dosing of REQORSA is further confirmation of its favorable safety profile and it enables us to advance Acclaim-1 into the final cohort of the Phase 1 dose escalation portion of the study," said Genprex Chief Medical Officer Mark Berger.
The company noted that study, includes up to three sequential dose escalation groups which will treat people with Reqorsa intravenously on Day 1 in addition to osimertinib 80 mg fixed dose oral daily tablet during 21-day treatment cycles until disease progression or unacceptable toxicity.
The first group received Reqorsa IV infusion at 0.06 mg/kg, the second group received 0.09 mg/kg, and the third group will receive 0.12 mg/kg, according to the company.
Berger added that the company plans to complete enrollment of the final cohort in Q1 2023.
GNPX +2.34% to $1.17 premarket Dec. 14
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Genprex gets safety panel nod to proceed in lung cancer study of Reqorsa