Genprex has received approval from the Safety Review Committee (SRC) to advance the Phase I/II Acclaim-1 clinical trial of Reqorsa Immunogene Therapy (quaratusugene ozeplasmid), plus AstraZeneca’s Tagrisso (osimertinib), for treating late-stage, non-small cell lung cancer (NSCLC).
The approval comes after SRC reviewed the first cohort of subjects in the Phase I segment of the trial and recommended increasing the dose in the second cohort of the Phase I trial.
The open-label, multicentre trial is analysing Reqorsa plus Tagrisso in late-stage NSCLC patients with activating epidermal growth factor receptor (EGFR) mutations, whose disease has progressed following Tagrisso treatment.
It has up to three sequential dose escalation cohorts, in which patients will be given intravenous (IV) Reqorsa on day one, along with an 80mg osimertinib oral tablet daily during the 21-day treatment cycles until disease progression is stopped or unacceptable toxicity is reached.
The Phase I dose escalation trial is anticipated to enrol up to 18 subjects to detect the maximum tolerated dose of the combination therapy.
The Phase II segment is planned to have nearly 74 subjects who will be randomised in a 1:1 ratio to receive either Reqorsa and Tagrisso combination treatment or Tagrisso as a single agent.
Progression-free survival, defined as the time from randomisation to progression or morality, is the primary endpoint of this portion.
Genprex plans to conduct an interim assessment on reporting 25 events.
A lead drug candidate of the company, Reqorsa is a pan-kinase inhibitor. It consists of a tumour suppressor gene, TUSC2 gene, as the active ingredient.
Genprex chief medical officer Mark Berger said: “The SRC approval to advance Acclaim-1 to the higher dose in the second cohort of patients is an important milestone that further supports Reqorsa’s safety profile and brings us one step closer to bringing this potentially ground-breaking gene therapy approach to treating NSCLC to the patients who need it most.
“Enrollment in Acclaim-1 remains on track to complete the Phase 1 portion of the study by year end.”
In March this year, the company dosed the first subject in Phase I/II trial of Reqorsa plus Tagrisso for late-stage NSCLC.
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