{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T04:58:46Z","timestamp":1790744326326,"version":"4.1.0"},"reference-count":33,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T00:00:00Z","timestamp":1790640000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T00:00:00Z","timestamp":1790640000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Nimotuzumab is an anti\u2010epidermal growth factor receptor antibody. This Phase I study evaluated the pharmacokinetics and safety of nimotuzumab plus irinotecan in Chinese patients with advanced solid tumors. At single ascending dosage (SAD) stage, four cohorts (100, 200, 400, and 600\u00a0mg) of patients received nimotuzumab intravenously on Day 1, alongside irinotecan 180\u00a0mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    on Day 8. Three weeks later, all patients in the four cohorts transferred to multiple ascending dosage (MAD) stage: nimotuzumab was administrated weekly for 6 weeks, alongside irinotecan (Days 1, 15, 29, 43, and 57, 180\u00a0mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    ). Primary objective was pharmacokinetics, safety and tolerability was also examined. From December 2012 to October 2014, in SAD and MAD stages, there were 28 and 39 patients with Stage IV solid tumors. The area under the concentration curve (AUC\n                    <jats:sub>0\u2013\u221e<\/jats:sub>\n                    ) for a single dose of nimotuzumab was 10.2 \u00b1 2.7 (100\u00a0mg), 37.6 \u00b1 10.0 (200\u00a0mg), 114.8 \u00b1 35.5 (400\u00a0mg), 197.6 \u00b1 32.0 (600\u00a0mg) (\u00d7100 h \u00b5g\/mL), and for multiple dose, it was 26.7 \u00b1 3.4 (100\u00a0mg), 87.1 \u00b1 12.0 (200\u00a0mg), 193.4 \u00b1 46.9 (400\u00a0mg) and 446.3 \u00b1 100.7 (600\u00a0mg) (\u00d7100 h \u00b5g\/mL). There was low incidence of rash and no dose\u2010limiting toxicities occurred. This study indicated that nimotuzumab at doses ranging from 100 to 600\u00a0mg exhibited a manageable and tolerable safety profile.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70108","type":"journal-article","created":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T04:25:26Z","timestamp":1790742326000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Phase I Study of Nimotuzumab Combined with Irinotecan in Chinese Patients with Advanced Solid Tumors"],"prefix":"10.1002","volume":"15","author":[{"given":"Zhichao","family":"Jiang","sequence":"first","affiliation":[{"name":"Medical Oncology Department 5 Cancer Hospital Chinese Academy of Medical Sciences  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen","family":"Zhang","sequence":"additional","affiliation":[{"name":"Medical Oncology Department 5 Cancer Hospital Chinese Academy of Medical Sciences  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunxia","family":"Du","sequence":"additional","affiliation":[{"name":"Medical Oncology Department 5 Cancer Hospital Chinese Academy of Medical Sciences  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongkun","family":"Sun","sequence":"additional","affiliation":[{"name":"Medical Oncology Department 5 Cancer Hospital Chinese Academy of Medical Sciences  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aiping","family":"Zhou","sequence":"additional","affiliation":[{"name":"Medical Oncology Department 5 Cancer Hospital Chinese Academy of Medical Sciences  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,29]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1016\/j.phrs.2013.11.002","article-title":"The ErbB\/HER family of 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