{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T15:35:16Z","timestamp":1786980916118,"version":"build-2736575974"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2016,3,9]],"date-time":"2016-03-09T00:00:00Z","timestamp":1457481600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2016,3,9]],"date-time":"2016-03-09T00:00:00Z","timestamp":1457481600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Invest New Drugs"],"published-print":{"date-parts":[[2016,6]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:p>\n                    <jats:italic>Background<\/jats:italic>\n                    IMGN901 is a CD56-targeting antibody-drug conjugate designed for tumor-selective delivery of the cytotoxic maytansinoid DM1. This phase 1 study investigated the safety, tolerability, pharmacokinetics, and preliminary activity of IMGN901 in patients with CD56-expressing solid tumors.\n                    <jats:italic>Methods<\/jats:italic>\n                    Patients were enrolled in cohorts of escalating IMGN901 doses, administered intravenously, on 3 consecutive days every 21\u00a0days. A dose-expansion phase accrued patients with small cell lung cancer (SCLC), Merkel cell carcinoma (MCC), or ovarian cancer.\n                    <jats:italic>Results<\/jats:italic>\n                    Fifty-two patients were treated at doses escalating from 4 to 94\u00a0mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    \/day. The maximum tolerated dose (MTD) was determined to be 75\u00a0mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    . Dose-limiting toxicities included fatigue, neuropathy, headache or meningitis-like symptoms, chest pain, dyspnea, and myalgias. In the dose-expansion phase (\n                    <jats:italic>n<\/jats:italic>\n                    \u00a0=\u00a045), seven patients received 75\u00a0mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    and 38 received 60\u00a0mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    for up to 21\u00a0cycles. The recommended phase 2 dose (RP2D) was established at 60\u00a0mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    during dose expansion. Overall, treatment-emergent adverse events (TEAEs) were experienced by 96.9\u00a0% of all patients, the majority of which were Grade 1 or 2. The most commonly reported Grade 3 or 4 TEAEs were hyponatremia and dyspnea (each 8.2\u00a0%). Responses included 1 complete response (CR), 1 clinical CR, and 1 unconfirmed partial response (PR) in MCC; and 1 unconfirmed PR in SCLC. Stable disease was seen for 25\u00a0% of all evaluable patients who received doses \u226560\u00a0mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    .\n                    <jats:italic>Conclusions<\/jats:italic>\n                    The RP2D for IMGN901 of 60\u00a0mg\/m\n                    <jats:sup>2<\/jats:sup>\n                    administered for 3 consecutive days every 3\u00a0weeks was associated with an acceptable tolerability profile. Objective responses were observed in patients with advanced CD56+ cancers.\n                  <\/jats:p>","DOI":"10.1007\/s10637-016-0336-9","type":"journal-article","created":{"date-parts":[[2016,3,8]],"date-time":"2016-03-08T23:41:34Z","timestamp":1457480494000},"page":"290-299","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":58,"title":["Phase I study of IMGN901, a CD56-targeting antibody-drug conjugate, in patients with CD56-positive solid tumors"],"prefix":"10.1007","volume":"34","author":[{"given":"Manisha H.","family":"Shah","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Lorigan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary E. 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FVF acknowledges support from ImmunoGen, Inc. KNM has been a member of the Speakers Bureau for Genentech\/Roche and a consultant\/advisory board member of Genentech, ImmunoGen Inc., Advaxis, and Astra Zeneca. The remaining authors declare no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Written informed consent was obtained from all participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}