{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T13:11:40Z","timestamp":1787317900072,"version":"build-2736575974"},"reference-count":16,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100018537","name":"national science and technology major project","doi-asserted-by":"publisher","award":["2020ZX09201-013"],"award-info":[{"award-number":["2020ZX09201-013"]}],"id":[{"id":"10.13039\/501100018537","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"national natural science foundation of china","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Shanghai Municipal Science and Technology Commission Guidance Shanghai Municipal Science and Technology Commission Guidance","award":["18411967800"],"award-info":[{"award-number":["18411967800"]}]},{"DOI":"10.13039\/501100008750","name":"shanghai hospital development center","doi-asserted-by":"publisher","award":["SHDC12018X03"],"award-info":[{"award-number":["SHDC12018X03"]}],"id":[{"id":"10.13039\/501100008750","id-type":"DOI","asserted-by":"publisher"}]},{"name":"CSCO-ROCHE Cancer Research Fund 2019","award":["Y-2019Roche-171"],"award-info":[{"award-number":["Y-2019Roche-171"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ther Adv Med Oncol"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Pucotenlimab is a humanized immunoglobulin G4 (IgG4) anti programmed cell death protein 1 (anti-PD-1) monoclonal antibody (mAb) with a S228P hinge mutation and an engineered Fc domain. Preclinical data suggests that pucotenlimab exerts antitumor effects. In this phase I study, which was prospectively registered on www.chinadrugtrials.org.cn (CTR20180125), the safety, maximum tolerated dose, preliminary antitumor activity, pharmacokinetics, and immunogenicity of pucotenlimab were evaluated in patients with advanced solid tumors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Patients with advanced solid tumors refractory to standard therapies were recruited. In a 3+3 dose escalation study, 13 patients received pucotenlimab intravenously every 3\u2009weeks (Q3W) until disease progression or unacceptable toxicity occurred at doses of 1\u2009mg\/kg, 3\u2009mg\/kg, 10\u2009mg\/kg, and 200\u2009mg. 17 additional patients were assigned in the expansion period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>A total of 30 patients were enrolled. No dose-limiting toxicity was observed. The maximum tolerated dose was not reached. The most common treatment-related adverse events of any grade were proteinuria (40%), fatigue (36.7%), weight loss (26.7%), fever (26.7%), increased aspartate aminotransferase (26.7%), rash (23.3%), and anorexia (20.0%). Partial responses occurred in five patients, with an objective response rate of 16.7%. Pharmacokinetics analysis showed rapid absorption followed by slow terminal elimination, with a mean half-life of 17.1\u201323.5\u2009days across all dose groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Pucotenlimab had an acceptable toxicity profile at doses up to 10\u2009mg\/kg and the maximum tolerated dose was not reached. Based on the pharmacokinetics, efficacy, and safety profile, 3\u2009mg\/kg Q3W or 200\u2009mg Q3W are optimal for further drug development.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17588359211020528","type":"journal-article","created":{"date-parts":[[2021,5,31]],"date-time":"2021-05-31T03:12:56Z","timestamp":1622430776000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":14,"title":["Phase I study of pucotenlimab (HX008), an anti-PD-1 antibody, for patients with advanced solid tumors"],"prefix":"10.1177","volume":"13","author":[{"given":"Rujiao","family":"Liu","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, P.R. China"},{"name":"Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, P.R., China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenhua","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, P.R. China"},{"name":"Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, P.R., China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanchun","family":"Meng","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, P.R. China"},{"name":"Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, P.R., China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuiping","family":"Gao","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, P.R. China"},{"name":"Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, P.R., China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, 200032, P.R. China"},{"name":"Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xichun","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, 200032, P.R. China"},{"name":"Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2021,5,31]]},"reference":[{"key":"bibr1-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1007\/s00262-004-0593-x"},{"key":"bibr2-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.27.2146"},{"key":"bibr3-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1186\/s12943-018-0928-4"},{"key":"bibr4-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1158\/2326-6066.CIR-16-0365"},{"key":"bibr5-17588359211020528","first-page":"727","volume":"10","author":"Han Y","year":"2020","journal-title":"Am J Cancer Res"},{"key":"bibr6-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1200694"},{"key":"bibr7-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.59.4358"},{"key":"bibr8-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-14-2607"},{"key":"bibr9-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-016-0347-6"},{"key":"bibr10-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharmthera.2018.09.008"},{"key":"bibr11-17588359211020528","first-page":"1724751","volume":"12","author":"Zhang J","year":"2020","journal-title":"InMabs"},{"key":"bibr12-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1186\/s40425-015-0078-9"},{"key":"bibr13-17588359211020528","doi-asserted-by":"publisher","DOI":"10.2217\/fon.15.52"},{"key":"bibr14-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.26.7609"},{"key":"bibr15-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1500596"},{"key":"bibr16-17588359211020528","doi-asserted-by":"publisher","DOI":"10.1126\/science.aaa1348"}],"container-title":["Therapeutic Advances in Medical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17588359211020528","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17588359211020528","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17588359211020528","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T22:26:01Z","timestamp":1777587961000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/17588359211020528"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1]]},"references-count":16,"alternative-id":["10.1177\/17588359211020528"],"URL":"https:\/\/doi.org\/10.1177\/17588359211020528","relation":{},"ISSN":["1758-8359","1758-8359"],"issn-type":[{"value":"1758-8359","type":"print"},{"value":"1758-8359","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,1]]},"article-number":"17588359211020528"}}