{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T02:06:41Z","timestamp":1792634801991,"version":"4.5.0"},"reference-count":27,"publisher":"American Association for the Advancement of Science (AAAS)","issue":"8","license":[{"start":{"date-parts":[[2020,6,26]],"date-time":"2020-06-26T00:00:00Z","timestamp":1593129600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100012166","name":"National Key R&D Program of China","doi-asserted-by":"crossref","award":["2018YFC1313300"],"award-info":[{"award-number":["2018YFC1313300"]}],"id":[{"id":"10.13039\/501100012166","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81930065"],"award-info":[{"award-number":["81930065"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003453","name":"Natural Science Foundation of Guangdong Province","doi-asserted-by":"publisher","award":["2014A030312015"],"award-info":[{"award-number":["2014A030312015"]}],"id":[{"id":"10.13039\/501100003453","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Commun"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p xml:lang=\"en\">Several programmed cell death ligand 1 (PD\u2010L1)\/programmed cell death protein 1 (PD\u20101) antibodies have been approved for cancer treatment worldwide. Their pharmacokinetic and pharmacodynamic characteristics have been reported mainly in western countries, but related data in Chinese patients are limited. This study was conducted to investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of an anti\u2010PD\u20101 antibody, toripalimab, in Chinese patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p xml:lang=\"en\">A single\u2010center phase I study was conducted in Sun Yat\u2010sen University Cancer Center. Eligible patients were adults with histologically confirmed, treatment\u2010refractory, advanced, solitary malignant tumors. Toripalimab was intravenously infused every 2\u00a0weeks in dose\u2010escalating cohorts at 0.3\u00a0mg\/kg, 1\u00a0mg\/kg, 3\u00a0mg\/kg, 10\u00a0mg\/kg, and 240\u00a0mg. The study followed standard 3 + 3 design.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      Between 15\n                      <jats:sup>th<\/jats:sup>\n                      March 2016 and 27\n                      <jats:sup>th<\/jats:sup>\n                      September 2016, 25 patients were enrolled, of whom 3 (12.0%), 7 (28.0%), 6 (24.0%), 6 (24.0%), 3 (12.0%) received 0.3\u00a0mg\/kg, 1\u00a0mg\/kg, 3\u00a0mg\/kg, 10\u00a0mg\/kg, and 240\u00a0mg toripalimab, respectively. After a median follow\u2010up time of 5.0\u00a0months (range: 1.5\u201019.8\u00a0months), we observed that the commonest treatment\u2010related adverse events (TRAEs) were fatigue (64.0%) and rash (24.0%). No grade 3 or higher TRAEs were observed. No dose\u2010limiting toxicity, treatment\u2010related serious adverse events (SAEs), or treatment\u2010related death occurred. Objective response rate was 12.5%. The half\u2010life of toripalimab was 150\u2010222 h after a single dose infusion. Most patients, including those from the 0.3\u00a0mg\/kg group, maintained complete PD\u20101 receptor occupancy (&gt;\u00a080%) on activated T cells since receiving the first dose of toripalimab.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p xml:lang=\"en\">Toripalimab is a promising anti\u2010PD\u20101 antibody, which was well tolerated and demonstrated anti\u2010tumor activity in treatment\u2010refractory advanced solitary malignant tumors. Further exploration in various tumors and combination therapies is warranted.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cac2.12068","type":"journal-article","created":{"date-parts":[[2020,6,27]],"date-time":"2020-06-27T04:46:54Z","timestamp":1593233214000},"page":"345-354","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":51,"title":["A phase I study of toripalimab, an anti\u2010PD\u20101 antibody, in patients with refractory malignant solid tumors"],"prefix":"10.34133","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9284-3237","authenticated-orcid":false,"given":"Xiao\u2010Li","family":"Wei","sequence":"first","affiliation":[{"name":"Sun Yat\u2010sen University Cancer Center","place":["Guangzhou, P. R. 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