KaliVir Immunotherapeutics has concluded the first cohort in the Phase I/Ib STEALTH-001 trial evaluating VET3-TGI for individuals with incurable, advanced solid tumours.
The Data Safety Committee was responsible for monitoring the overall risk-benefit and safety of the therapy in the study.
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After the first cohort dosing in the trial’s dose escalation part, the committee granted approval for the trial to continue.
This dose escalation and expansion study is now moving forward with the dosing of subsequent intratumoural (IT) and intravenous (IV) infusion cohorts.
It is designed to assess the oncolytic immunotherapy VET3-TGI both as a single agent and in conjunction with a checkpoint inhibitor in those with pathologically confirmed, unresectable or metastatic solid tumours.
The trial’s dose escalation phase is structured into four groups, with the first two determining the highest tolerated doses of the therapy when administered intratumourally and intravenously.
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By GlobalDataThe third and fourth groups will explore the combination therapy with pembrolizumab.
These groups are said to start at the highest tolerated doses identified in the third and fourth groups.
Upon establishing the highest tolerated doses in the groups, the dose may be expanded to include up to 15 additional subjects to further assess VET3-TGI’s efficacy. The trial has seven locations across the US.
KaliVir Immunotherapeutics chief medical officer James Burke said: “The safety profile demonstrated in our initial first-in- human cohort is critical as it opens up expanded dosing in both the study’s IV infusion and IT injection arms which will continue in parallel on study STEALTH-001.
“We are excited to assess not only the safety of VET3-TGI but further investigate both proof of concept and anti-tumour activity moving forward.”
According to the company, the therapy selectively destroys tumour cells while simultaneously expressing a payload of immuno-stimulatory transgene, which comprises interleukin-12 and a transforming growth factor beta (TGFbeta) inhibitor.
