Inactivated hemagglutinating virus of Japan envelope (HVJ-E) have an anti-tumor effect and tumor immunity. We conducted an open-label, phase I, dose-escalation study in patients with castration-resistant prostate cancer (CRPC) to determine the safety and efficacy of intratumoral and subcutaneous injection of HVJ-E (GEN0101). Patients with CRPC, who were resistant to or unable to receive standard of care, were included. GEN0101 was injected directly into the prostate and subcutaneously in two 28-day treatment cycles. The primary end points were to evaluate safety and tolerability of GEN0101 and determine its recommended dose. The secondary end points were to analyze anti-tumor effect and tumor immunity. Three patients received 30,000 mNAU of GEN0101 while 6 received 60,000 mNAU. There was no dose-limiting toxicity, and the recommended dose of GEN0101 was defined to be 60,000 mNAU. Radiographically, one patient had stable disease and 2 had progressive disease in the low-dose group, whereas 5 patients had stable disease and one had progressive disease in the high-dose group. Three patients in the high-dose group showed reduction in lymph node metastasis. PSA increase rates in the high-dose group were suppressed more than those in the low-dose group. NK cell activity was enhanced in 2 patients of the low-dose group and in 5 patients in the high-dose group. In conclusions, intratumoral and subcutaneous injections of GEN0101 were well tolerated and feasible to use. The study is registered at UMIN Clinical Trials Registry, number UMIN000017092.This article is protected by copyright. All rights reserved.
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