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Gianluca","nameType":"Personal","givenName":"Gianluca","familyName":"Spitaleri","affiliation":[],"nameIdentifiers":[]},{"name":"Masini, Cristina","nameType":"Personal","givenName":"Cristina","familyName":"Masini","affiliation":[],"nameIdentifiers":[]},{"name":"Pierantoni, Chiara","nameType":"Personal","givenName":"Chiara","familyName":"Pierantoni","affiliation":[],"nameIdentifiers":[]},{"name":"Reinerio González-Iglesias","affiliation":[],"nameIdentifiers":[]},{"name":"Zigon, Giulia","nameType":"Personal","givenName":"Giulia","familyName":"Zigon","affiliation":[],"nameIdentifiers":[]},{"name":"Annaelisa Tasciotti","affiliation":[],"nameIdentifiers":[]},{"name":"Giovannoni, Leonardo","nameType":"Personal","givenName":"Leonardo","familyName":"Giovannoni","affiliation":[],"nameIdentifiers":[]},{"name":"Lovato, Valeria","nameType":"Personal","givenName":"Valeria","familyName":"Lovato","affiliation":[],"nameIdentifiers":[]},{"name":"Elia, Giuliano","nameType":"Personal","givenName":"Giuliano","familyName":"Elia","affiliation":[],"nameIdentifiers":[]},{"name":"Menssen, Hans D","nameType":"Personal","givenName":"Hans D","familyName":"Menssen","affiliation":[],"nameIdentifiers":[]},{"name":"Neri, Dario","nameType":"Personal","givenName":"Dario","familyName":"Neri","affiliation":[],"nameIdentifiers":[]},{"name":"Cascinu, Stefano","nameType":"Personal","givenName":"Stefano","familyName":"Cascinu","affiliation":[],"nameIdentifiers":[]},{"name":"Conte, Pier Franco","nameType":"Personal","givenName":"Pier Franco","familyName":"Conte","affiliation":[],"nameIdentifiers":[]},{"name":"Braud, Filippo De","nameType":"Personal","givenName":"Filippo De","familyName":"Braud","affiliation":[],"nameIdentifiers":[]}],"titles":[{"title":"The tumor-targeting immunocytokine F16-IL2 in combination with doxorubicin: dose escalation in patients with advanced solid tumors and expansion into patients with metastatic breast cancer"}],"publisher":"Taylor \u0026 Francis","container":{},"publicationYear":2015,"subjects":[{"subject":"60506 Virology","subjectScheme":"FOR"},{"subject":"FOS: Biological sciences","schemeUri":"http://www.oecd.org/science/inno/38235147.pdf","subjectScheme":"Fields of Science and Technology (FOS)"},{"subject":"FOS: Biological sciences","subjectScheme":"Fields of Science and Technology (FOS)"},{"subject":"110309 Infectious Diseases","subjectScheme":"FOR"},{"subject":"FOS: Health sciences","schemeUri":"http://www.oecd.org/science/inno/38235147.pdf","subjectScheme":"Fields of Science and Technology (FOS)"},{"subject":"FOS: Health sciences","subjectScheme":"Fields of Science and Technology (FOS)"},{"subject":"Hematology"},{"subject":"Cancer"},{"subject":"Biological Sciences"},{"subject":"Immunology"},{"subject":"FOS: Clinical medicine","schemeUri":"http://www.oecd.org/science/inno/38235147.pdf","subjectScheme":"Fields of Science and Technology (FOS)"},{"subject":"FOS: Clinical medicine","subjectScheme":"Fields of Science and Technology (FOS)"},{"subject":"Chemistry"},{"subject":"Pharmacology"},{"subject":"Medicine"},{"subject":"Biochemistry"}],"contributors":[],"dates":[{"date":"2015-10-08","dateType":"Created"},{"date":"2016-01-19","dateType":"Updated"},{"date":"2015","dateType":"Issued"}],"language":null,"types":{"ris":"DATA","bibtex":"misc","citeproc":"dataset","schemaOrg":"Dataset","resourceType":"Dataset","resourceTypeGeneral":"Dataset"},"relatedIdentifiers":[{"relationType":"IsSupplementTo","relatedIdentifier":"10.4161/19336918.2014.983785","relatedIdentifierType":"DOI"},{"relationType":"IsPreviousVersionOf","relatedIdentifier":"10.6084/m9.figshare.1285024","relatedIdentifierType":"DOI"}],"relatedItems":[],"sizes":["44052850 Bytes"],"formats":[],"version":null,"rightsList":[{"rights":"Creative Commons Attribution 4.0 International","rightsUri":"https://creativecommons.org/licenses/by/4.0/legalcode","schemeUri":"https://spdx.org/licenses/","rightsIdentifier":"cc-by-4.0","rightsIdentifierScheme":"SPDX"}],"descriptions":[{"description":"A phase Ib/II trial was performed to evaluate safety, tolerability, recommended dose (RD) and efficacy of F16-IL2, a recombinant antibody-cytokine fusion protein, in combination with doxorubicin in patients with solid tumors (phase Ib) and metastatic breast cancer (phase II). Six patient cohorts with progressive solid tumors (n = 19) received escalating doses of F16-IL2 [5–25 Million International Units (MIU) of IL2 equivalent dose] in combination with escalating doses of doxorubicin (0–25 mg/m\u003csup\u003e2\u003c/sup\u003e) on day 1, 8 and 15 every 4 weeks. Subsequently, patients with metastatic breast cancer (n = 10) received the drug combination at the RD. Clinical data and laboratory findings were analyzed for safety, tolerability, and activity. F16-IL2 could be administered up to 25 MIU, in combination with the RD of doxorubicin (25 mg/m\u003csup\u003e2\u003c/sup\u003e). No human anti-fusion protein antibodies (HAFA) response was detected. Pharmacokinetics of F16-IL2 was dose-dependent over the tested range, with half-lives of ca. 13 and ca. 8 hours for cohorts dosed at lower and higher levels, respectively. Toxicities were controllable and reversible, with no combination treatment-related death. After 8 weeks, 57% and 67% disease control rates were observed for Phase I and II, respectively (decreasing to 43% and 33% after 12 weeks), considering 14 and 9 patients evaluable for efficacy. One patient experienced a long lasting partial response (45 weeks), still on-going at exit of study. F16-IL2 can be safely and repeatedly administered at the RD of 25 MIU in combination with 25 mg/m\u003csup\u003e2\u003c/sup\u003e doxorubicin; its safety and activity are currently being investigated in combination with other chemotherapeutics, in order to establish optimal therapy settings.","descriptionType":"Abstract"}],"geoLocations":[],"fundingReferences":[],"xml":"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