{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T13:47:21Z","timestamp":1793713641882,"version":"4.6.1"},"reference-count":38,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2021,11,29]],"date-time":"2021-11-29T00:00:00Z","timestamp":1638144000000},"content-version":"vor","delay-in-days":783,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Lessons Learned<\/jats:title>\n                  <jats:p>Concurrent ETBX-011, ETBX-051, and ETBX-061 can be safely administered to patients with advanced cancer. All patients developed CD4+ and\/or CD8+ T-cell responses after vaccination to at least one tumor-associated antigen (TAA) encoded by the vaccine; 5\/6 patients (83%) developed MUC1-specific T cells, 4\/6 (67%) developed CEA-specific T cells, and 3\/6 (50%) developed brachyury-specific T cells. The presence of adenovirus 5-neutralizing antibodies did not prevent the generation of TAA-specific T cells.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>A novel adenovirus-based vaccine targeting three human tumor-associated antigens\u2014CEA, MUC1, and brachyury\u2014has demonstrated antitumor cytolytic T-cell responses in preclinical animal models of cancer.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This open-label, phase I trial evaluated concurrent administration of three therapeutic vaccines (ETBX-011 = CEA, ETBX-061 = MUC1 and ETBX-051 = brachyury). All three vaccines used the same modified adenovirus 5 (Ad5) vector backbone and were administered at a single dose level (DL) of 5 \u00d7\u20091011 viral particles (VP) per vector. The vaccine regimen consisting of all three vaccines was given every 3\u2009weeks for three doses then every 8\u2009weeks for up to 1 year. Clinical and immune responses were evaluated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Ten patients enrolled on trial (DL1 = 6 with 4 in the DL1 expansion cohort). All treatment-related adverse events were temporary, self-limiting, grade 1\/2 and included injection site reactions and flu-like symptoms. Antigen-specific T cells to MUC1, CEA, and\/or brachyury were generated in all patients. There was no evidence of antigenic competition. The administration of the vaccine regimen produced stable disease as the best clinical response.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Concurrent ETBX-011, ETBX-051, and ETBX-061 can be safely administered to patients with advanced cancer. Further studies of the vaccine regimen in combination with other agents, including immune checkpoint blockade, are planned.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1634\/theoncologist.2019-0608","type":"journal-article","created":{"date-parts":[[2019,10,8]],"date-time":"2019-10-08T18:04:08Z","timestamp":1570557848000},"page":"479-e899","source":"Crossref","is-referenced-by-count":56,"title":["A Phase I Trial Using a Multitargeted Recombinant Adenovirus 5 (CEA\/MUC1\/Brachyury)-Based Immunotherapy Vaccine Regimen in Patients with Advanced Cancer"],"prefix":"10.1093","volume":"25","author":[{"given":"Margaret E.","family":"Gatti-Mays","sequence":"first","affiliation":[{"name":"Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason 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