{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T16:48:31Z","timestamp":1785775711154,"version":"3.56.0"},"reference-count":25,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T00:00:00Z","timestamp":1779840000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T00:00:00Z","timestamp":1779840000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2026,8]]},"abstract":"ABSTRACT<\/jats:title>\n \n The dose escalation part of the first\u2010in\u2010human study of E7130 in patients with advanced solid tumors determined the Recommended Phase 2 Dose (RP2D) of E7130 (480\u2009\u03bcg\/m\n 2<\/jats:sup>\n Q3W). The dose expansion part (presented here) examined safety\/preliminary efficacy in patients with squamous cell carcinoma of the head and neck (SCCHN) and urothelial carcinoma (UC). Patients\u2009\u2265\u200920\u2009years of age with previously treated SCCHN\/UC were treated at the RP2D. The primary objective was to characterize tolerability\/safety. Secondary objectives included preliminary efficacy (including objective response rate [ORR], progression\u2010free survival [PFS], and duration of response [DOR] by investigator per Response Evaluation Criteria In Solid Tumors version 1.1 [RECIST v1.1] and overall survival [OS]). Treatment\u2010emergent adverse events (TEAEs) were recorded. In patients with SCCHN, tissue biomarker analyses were performed. Kaplan\u2013Meier method was used to estimate PFS, DOR, and OS. The Greenwood formula and log\u2013log transformation were used to estimate 95% CIs. Eight patients (SCCHN,\n n<\/jats:italic>\n \u2009=\u20092; UC,\n n<\/jats:italic>\n \u2009=\u20096) were treated with the RP2D; 10 additional patients (SCCHN,\n n<\/jats:italic>\n \u2009=\u20097; UC,\n n<\/jats:italic>\n \u2009=\u20093) were treated at a reduced dose (410\u2009\u03bcg\/m\n 2<\/jats:sup>\n Q3W). All patients had \u2265\u20091 TEAE; 66.7% had serious TEAEs. Patients with UC treated at the RP2D had an ORR of 66.7%; no other responses were observed. Median PFS\/OS in patients with SCCHN treated at 480\u2009\u03bcg\/m\n 2<\/jats:sup>\n were 2.8\/7.7\u2009months and at 410\u2009\u03bcg\/m\n 2<\/jats:sup>\n were 3.5\/5.0\u2009months. Median PFS\/OS in patients with UC treated at 480\u2009\u03bcg\/m\n 2<\/jats:sup>\n were 6.6\/10.7\u2009months and at 410\u2009\u03bcg\/m\n 2<\/jats:sup>\n were 2.6\/11.9\u2009months. Biomarker analyses indicated tumor microenvironment amelioration. Further evaluation is needed to optimize efficacy and safety of E7130 in patients with SCCHN and UC.\n <\/jats:p>\n \n Trial Registration:<\/jats:bold>\n ClinicalTrials.gov<\/jats:ext-link>\n identifier: NCT03444701\n <\/jats:p>","DOI":"10.1111\/cas.70420","type":"journal-article","created":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T02:25:47Z","timestamp":1779935147000},"page":"2247-2258","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["First\u2010In\u2010Human Study: Dose Expansion of\n E7130<\/scp>\n in Urothelial Carcinoma and Squamous Cell Carcinoma of the Head and Neck"],"prefix":"10.1111","volume":"117","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9203-4245","authenticated-orcid":false,"given":"Nobuaki","family":"Matsubara","sequence":"first","affiliation":[{"name":"Department of Medical Oncology National Cancer Center Hospital East Kashiwa Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0179-3789","authenticated-orcid":false,"given":"Ken","family":"Saijo","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Tohoku University Hospital Sendai Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Shimizu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Hokkaido University Hospital Sapporo Hokkaido Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6639-9753","authenticated-orcid":false,"given":"Susumu","family":"Okano","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Medical Oncology National Cancer Center Hospital East Kashiwa Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Nakano","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Nishio","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology Nagoya University Hospital Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoyuki","family":"Otsuka","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Osaka International Cancer Institute Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirofumi","family":"Kuno","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Radiology National Cancer Center Hospital East Kashiwa Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuma","family":"Miura","sequence":"additional","affiliation":[{"name":"Japan and Asia Clinical Development Department Eisai Co. 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Ibaraki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abraham","family":"Apfel","sequence":"additional","affiliation":[{"name":"Clinical Data Science Eisai Inc. Nutley New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuanqing","family":"Ye","sequence":"additional","affiliation":[{"name":"Clinical Data Science Eisai Inc. 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