The study will determine the recommended dose of the combination treatment for participants with HER2 positive endometrial cancer. Credit: fizkes/Shutterstock.

ImmunityBio has announced the launch of the Phase I/II QUILT 502 clinical trial of ANKTIVA (nogapendekin alfa inbakicept-pmln), plus the investigational AdHER2DC vaccine, as a potential therapy for patients with HER2-expressing endometrial cancer.

Sponsored by the National Cancer Institute, part of the National Institutes of Health, the trial will investigate the safety and preliminary clinical efficacy of the combination therapy, which also includes pembrolizumab and lenvatinib, before proceeding to a larger study.

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Its aim is to explore the long-term effectiveness of ANKTIVA in replacing the short-term activity of checkpoint inhibitor immunotherapies.

The open-label, two-arm study will first determine the recommended dose of pembrolizumab, lenvatinib, ANKTIVA, and AdHER2DC for participants with HER2 positive endometrial cancer.

The subsequent Phase II portion will assess the efficacy of the combination regimen, measured by the proportion of subjects without disease progression at six months.

This study aims to enrol a total of 60 subjects and is anticipated to conclude in 2026.

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ANKTIVA is the company’s IL-15 superagonist immune enhancer and recently received Food and Drug Administration (FDA) approval for BCG-unresponsive non-muscle invasive bladder cancer CIS, with or without papillary tumours.

The AdHER2DC vaccine specifically targets the HER2 protein, which is overexpressed in 30% of endometrial cancer patients and more than 50% of high-risk subtypes.

ImmunityBio has a partnership in place with the NCI to study ANKTIVA in Lynch syndrome cases.

ImmunityBio executive chairman and global chief scientific and medical officer Patrick Soon-Shiong said: “We are pleased to partner with the NCI on this important cancer control study involving ANKTIVA, which has demonstrated in clinical trials that activation of memory T-cells may help deliver long-duration response well beyond that of checkpoint inhibitors alone.

“We are hopeful that the AdHER2DC investigational vaccine plus ANKTIVA will ‘rescue’ the checkpoint inhibitor pembrolizumab and kinase inhibitor lenvatinib and lead to an improved response compared with the current standard of care in this high risk population.”