{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T21:44:37Z","timestamp":1783633477715,"version":"3.55.0"},"reference-count":10,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,3,19]],"date-time":"2020-03-19T00:00:00Z","timestamp":1584576000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003988","name":"Japan Agency for Marine-Earth Science and Technology","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003988","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Inactivated hemagglutinating virus of Japan envelope (HVJ\u2010E) has an antitumor effect and tumor immunity. We undertook an open\u2010label, phase I, dose\u2010escalation study in patients with castration\u2010resistant prostate cancer (CRPC) to determine the safety and efficacy of intratumoral and s.c. injection of HVJ\u2010E (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 s.c. in two 28\u2010day treatment cycles. The primary end\u2010points were to evaluate the safety and tolerability of GEN0101 and determine its recommended dose. The secondary end\u2010points were to analyze the antitumor effect and tumor immunity. Three patients received 30\u00a0000 mNAU GEN0101 and 6 received 60\u00a0000 mNAU. There was no dose\u2010limiting toxicity, and the recommended dose of GEN0101 was defined as 60\u00a0000 mNAU. Radiographically, 1 patient had stable disease and 2 had progressive disease in the low\u2010dose group, whereas 5 patients had stable disease and 1 had progressive disease in the high\u2010dose group. Three patients in the high\u2010dose group showed reduction in lymph node metastasis. Prostate\u2010specific antigen increase rates in the high\u2010dose group were suppressed more than those in the low\u2010dose group. Natural killer cell activity was enhanced in 2 patients of the low\u2010dose group and in 5 patients in the high\u2010dose group. In conclusion, intratumoral and s.c. injections of GEN0101 were well\u2010tolerated and feasible to use. The study is registered with the UMIN Clinical Trials Registry (no. UMIN000017092).<\/jats:p>","DOI":"10.1111\/cas.14366","type":"journal-article","created":{"date-parts":[[2020,2,29]],"date-time":"2020-02-29T13:33:50Z","timestamp":1582983230000},"page":"1692-1698","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Intratumoral and s.c. injection of inactivated hemagglutinating virus of Japan envelope (GEN0101) in metastatic castration\u2010resistant prostate cancer"],"prefix":"10.1111","volume":"111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6774-7497","authenticated-orcid":false,"given":"Kazutoshi","family":"Fujita","sequence":"first","affiliation":[{"name":"Department of Urology Osaka University Graduate School of Medicine Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8681-1407","authenticated-orcid":false,"given":"Taigo","family":"Kato","sequence":"additional","affiliation":[{"name":"Department of Urology Osaka University Graduate School of Medicine Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Hatano","sequence":"additional","affiliation":[{"name":"Department of Urology Osaka University Graduate School of Medicine Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9369-4264","authenticated-orcid":false,"given":"Atsunari","family":"Kawashima","sequence":"additional","affiliation":[{"name":"Department of Urology Osaka University Graduate School of Medicine Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Ujike","sequence":"additional","affiliation":[{"name":"Department of Urology Osaka University Graduate School of Medicine Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Motohide","family":"Uemura","sequence":"additional","affiliation":[{"name":"Department of Urology Osaka University Graduate School of Medicine Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryoichi","family":"Imamura","sequence":"additional","affiliation":[{"name":"Department of Urology Osaka University Graduate School of Medicine Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Okihara","sequence":"additional","affiliation":[{"name":"Department of Urology Kyoto Prefectural University of Medicine Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osamu","family":"Ukimura","sequence":"additional","affiliation":[{"name":"Department of Urology Kyoto Prefectural University of Medicine Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsuneharu","family":"Miki","sequence":"additional","affiliation":[{"name":"Department of Urology Kyoto Prefectural University of Medicine Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshihiro","family":"Nakajima","sequence":"additional","affiliation":[{"name":"GenomIdea, Inc. 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