{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:35:38Z","timestamp":1792787738047,"version":"4.5.0"},"reference-count":52,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Top-level Clinical Discipline Project of Shanghai Pudong","award":["No. PWYgf2021-07"],"award-info":[{"award-number":["No. PWYgf2021-07"]}]},{"name":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ther Adv Med Oncol"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Immune checkpoint inhibitor therapy has demonstrated impressive clinical benefits in multiple tumor types. TQB2450, a novel monoclonal antibody targeting programmed cell death ligand 1, has shown safety and efficacy in preclinical studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>This first-in-human study aimed to evaluate the safety\/tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of TQB2450 in patients with advanced malignant tumors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design and methods:<\/jats:title>\n                    <jats:p>In this phase I study, eligible patients with advanced malignant tumors received intravenous TQB2450 once every 3\u2009weeks. This study consisted of a 3\u2009+\u20093 dose-escalation phase (1\u201330\u2009mg\/kg) and a specific dose-expansion phase (1200\u2009mg). The primary endpoints were maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and safety. The secondary endpoints were PK, immunogenicity, and investigator-assessed response rate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Between April 2018 and February 2020, 40 patients were enrolled (22 in the dose-escalation phase and 18 in the dose-expansion phase). No DLT was reported and the MTD was not reached. Grade \u2a7e3 or worse treatment-related treatment-emergent adverse events (AEs) occurred in 11 (27.50%) patients, with the most frequent being aspartate aminotransferase increased (5.00%), leukopenia (5.00%), and anemia (5.00%). Treatment-related serious AEs were reported in six patients, the most common of which was decompensated liver function (5.00%). No treatment-related death was reported. The maximum serum concentration of TQB2450 increased in a dose-proportional manner. Treatment-induced anti-drug antibodies were detected in 31.58% (12\/38) of patients. The investigator assessed the objective response rate as 5.00% and the disease control rate was 52.50%, including 2 partial responses and 19 stable diseases. The median progression-free survival was 2.69 (95% confidence interval, 2.07\u20136.14)\u2009months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>TQB2450 has a manageable safety profile with favorable PK and immunogenicity and has shown early evidence of clinical activity in advanced malignant tumors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>ClinicalTrials.gov identifier:<\/jats:title>\n                    <jats:p>NCT03460457.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17588359231220516","type":"journal-article","created":{"date-parts":[[2024,1,6]],"date-time":"2024-01-06T04:04:21Z","timestamp":1704513861000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["TQB2450 in patients with advanced malignant tumors: results from a phase I dose-escalation and expansion study"],"prefix":"10.1177","volume":"16","author":[{"given":"Junli","family":"Xue","sequence":"first","affiliation":[{"name":"Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liqiong","family":"Xue","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenbo","family":"Tang","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoxiao","family":"Ge","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qun","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Peng","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China"},{"name":"Pyrotech (Beijing) Biotechnology Co., Ltd, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Congqi","family":"Dai","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, China"},{"name":"China Innovation Center of Roche, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1813-9815","authenticated-orcid":false,"given":"Ye","family":"Guo","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, No. 1800 Yuntai Road, Shanghai 200123, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, No. 1800 Yuntai Road, Shanghai 200123, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,1,6]]},"reference":[{"key":"bibr1-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1038\/s41423-020-0488-6"},{"key":"bibr2-17588359231220516","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21596"},{"key":"bibr3-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1038\/s41573-018-0006-z"},{"key":"bibr4-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1186\/s12929-019-0601-2"},{"key":"bibr5-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1038\/nri.2017.108"},{"key":"bibr6-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1186\/s40425-019-0768-9"},{"key":"bibr7-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1002\/jcp.27172"},{"key":"bibr8-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-pathol-042020-042741"},{"key":"bibr9-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-18-0367"},{"key":"bibr10-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2019.0393"},{"key":"bibr11-17588359231220516","doi-asserted-by":"publisher","DOI":"10.2217\/fon-2020-1222"},{"key":"bibr12-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-021-00574-0"},{"key":"bibr13-17588359231220516","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S267433"},{"key":"bibr14-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw217"},{"key":"bibr15-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1186\/s13045-019-0779-5"},{"key":"bibr16-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.TARG-17-A200"},{"key":"bibr17-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61602-X"},{"key":"bibr18-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1038\/s41416-022-02128-3"},{"key":"bibr19-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2018.36.4_suppl.92"},{"key":"bibr20-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1007\/s00262-021-03102-3"},{"key":"bibr21-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2015.33.15_suppl.3023"},{"key":"bibr22-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1016\/j.xcrm.2022.100689"},{"key":"bibr23-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1002\/hep.32548"},{"key":"bibr24-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2020.08.646"},{"key":"bibr25-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdz253.093"},{"key":"bibr26-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(17)30239-5"},{"key":"bibr27-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(19)30693-X"},{"key":"bibr28-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-22-1785"},{"key":"bibr29-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2023.41.4_suppl.377"},{"key":"bibr30-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1002\/cam4.3771"},{"key":"bibr31-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2022.40.16_suppl.e23559"},{"key":"bibr32-17588359231220516","volume":"16","author":"Han B","year":"2021","journal-title":"J Thorac Oncol"},{"key":"bibr33-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2018.3039"},{"key":"bibr34-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-016-0618-8"},{"key":"bibr35-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0782-5"},{"key":"bibr36-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0749-6"},{"key":"bibr37-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-022-01671-w"},{"key":"bibr38-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13127"},{"key":"bibr39-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1186\/s40425-019-0586-0"},{"key":"bibr40-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-015-9857-y"},{"key":"bibr41-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-014-9599-2"},{"key":"bibr42-17588359231220516","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2016.00021"},{"key":"bibr43-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-20-2821"},{"key":"bibr44-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-022-01287-7"},{"key":"bibr45-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdy432.006"},{"key":"bibr46-17588359231220516","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S162214"},{"key":"bibr47-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2015.33.15_suppl.8029"},{"key":"bibr48-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2015.33.15_suppl.8032"},{"key":"bibr49-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2016.11.240"},{"key":"bibr50-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2021.107870"},{"key":"bibr51-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1007\/s11899-020-00589-y"},{"key":"bibr52-17588359231220516","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2021004511"}],"container-title":["Therapeutic Advances in Medical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17588359231220516","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17588359231220516","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17588359231220516","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T22:29:26Z","timestamp":1777588166000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/17588359231220516"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1]]},"references-count":52,"alternative-id":["10.1177\/17588359231220516"],"URL":"https:\/\/doi.org\/10.1177\/17588359231220516","relation":{},"ISSN":["1758-8359","1758-8359"],"issn-type":[{"value":"1758-8359","type":"print"},{"value":"1758-8359","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1]]},"article-number":"17588359231220516"}}