{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T22:14:04Z","timestamp":1793830444456,"version":"4.6.1"},"reference-count":24,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,9,18]],"date-time":"2023-09-18T00:00:00Z","timestamp":1694995200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,9,18]],"date-time":"2023-09-18T00:00:00Z","timestamp":1694995200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100014382","name":"Ipsen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100014382","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008375","name":"University of Basel","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100008375","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Nucl Med Mol Imaging"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>We present the results of an open-label, phase I\/II study evaluating the safety and efficacy of the novel somatostatin receptor (SSTR) antagonist [<jats:sup>177<\/jats:sup>Lu]Lu-satoreotide tetraxetan in 40 patients with previously treated, progressive neuroendocrine tumours (NETs), in which dosimetry was used to guide maximum administered activity.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This study was conducted in two parts. Part A consisted of 15 patients who completed three cycles of [<jats:sup>177<\/jats:sup>Lu]Lu-satoreotide tetraxetan at a fixed administered activity and peptide amount per cycle (4.5\u00a0GBq\/300\u00a0\u00b5g). Part B, which included 25 patients who received one to five cycles of [<jats:sup>177<\/jats:sup>Lu]Lu-satoreotide tetraxetan, evaluated different administered activities (4.5 or 6.0\u00a0GBq\/cycle) and peptide amounts (300, 700, or 1300\u00a0\u03bcg\/cycle), limited to a cumulative absorbed radiation dose of 23\u00a0Gy to the kidneys and 1.5\u00a0Gy to the bone marrow.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Median cumulative administered activity of [<jats:sup>177<\/jats:sup>Lu]Lu-satoreotide tetraxetan was 13.0\u00a0GBq over three cycles (13.1\u00a0GBq in part A and 12.9\u00a0GBq in part B). Overall, 17 (42.5%) patients experienced grade\u2009\u2265\u20093 treatment\u2011related adverse events; the most common were lymphopenia, thrombocytopenia, and neutropenia. No grade 3\/4 nephrotoxicity was observed. Two patients developed myeloid neoplasms considered treatment related by the investigator. Disease control rate for part A and part B was 94.7% (95% confidence interval [CI]: 82.3\u201399.4), and overall response rate was 21.1% (95% CI: 9.6\u201337.3).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>[<jats:sup>177<\/jats:sup>Lu]Lu-satoreotide tetraxetan, administered at a median cumulative activity of 13.0\u00a0GBq over three cycles, has an acceptable safety profile with a promising clinical response in patients with progressive, SSTR-positive NETs. A 5-year long-term follow-up study is ongoing.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov, NCT02592707. Registered October 30, 2015.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00259-023-06383-1","type":"journal-article","created":{"date-parts":[[2023,9,18]],"date-time":"2023-09-18T09:01:52Z","timestamp":1695027712000},"page":"183-195","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":58,"title":["A phase I\/II study of the safety and efficacy of [177Lu]Lu-satoreotide tetraxetan in advanced somatostatin receptor-positive neuroendocrine tumours"],"prefix":"10.1007","volume":"51","author":[{"given":"Damian","family":"Wild","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henning","family":"Gr\u00f8nb\u00e6k","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaunak","family":"Navalkissoor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Haug","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillaume P.","family":"Nicolas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben","family":"Pais","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Ansquer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Mathieu","family":"Beauregard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"McEwan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Lassmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniele","family":"Pennestri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magali","family":"Volteau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nat P.","family":"Lenzo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodney J.","family":"Hicks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,9,18]]},"reference":[{"key":"6383_CR1","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1056\/NEJMoa1607427","volume":"376","author":"J Strosberg","year":"2017","unstructured":"Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, et al. 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DW: received personal fees from Ipsen and grants from Siemens Healthineers. HG: received research grants from Abbvie, Intercept, ARLA Food for Health, and ADS AIPHIA Development Services AG; received consulting fees from Ipsen, NOVO, and Pfizer; lectures for AstraZeneca and EISAI; and serves on the Data Monitoring Committee at IQVIA. CA: received personal and consulting fees from Novartis\/AAA. SN and JMB: received honoraria and\/or consulting fees from Ipsen and Novartis\/AAA. BP and AM: received consulting fees from Ariceum and were employed by Ipsen at the time of study initiation and conduct. ML: received research grants from Ipsen, NordicNanovector, Novartis, and PentixaPharm. DP and MV: employees of Ipsen. RJH: shares in Telix Pharmaceuticals. No other conflicts of interest exist.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}