{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,11]],"date-time":"2026-04-11T01:32:12Z","timestamp":1775871132830,"version":"3.50.1"},"reference-count":26,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2024,8,28]],"date-time":"2024-08-28T00:00:00Z","timestamp":1724803200000},"content-version":"vor","delay-in-days":240,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","award":["NCI P30 CA006973"],"award-info":[{"award-number":["NCI P30 CA006973"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Lisavanbulin (BAL101553) is a small, lipophilic, oral microtubule destabilizer with promising antitumoral activity observed in preclinical glioblastoma (GBM) models.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This multicenter phase 1 study sought to determine the MTD of oral Lisavanbulin in combination with standard RT (60 Gy\/30 fractions) but without temozolomide in patients with newly diagnosed MGMT promoter unmethylated GBM (uGBM). Dose escalation followed a modified 3\u2005+\u20053 design. Secondary objectives included estimation of OS and PFS and pharmacokinetic analysis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Twenty-six patients with uGBM (median age, 63 years, 42.3% male, 61.5% with gross total resection, median Karnofsky performance status 80) were enrolled; 2 tumors had an IDH1 mutation. Predefined dose levels of Lisavanbulin, administered daily concomitantly with RT, were: 4\u00a0mg (5 pts), 6\u00a0mg (5 pts), 8\u00a0mg (7 pts), 12\u00a0mg (5 pts), and 15\u00a0mg (4 pts). The initial starting dose was 8\u00a0mg. Due to grade 4 aseptic meningoencephalitis in the first patient, the dose was decreased to 4\u00a0mg. Dose escalation resumed and continued to 15\u00a0mg with dose-limiting toxicities of grade 2 confusion and memory impairment observed at 12\u00a0mg. Avanbulin exposures increased in a relatively dose-proportional manner with increasing oral dose of Lisavanbulin from 4 to 15\u00a0mg.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Lisavanbulin in combination with RT was considered safe up to the highest predefined oral dose level of 15\u00a0mg daily.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/noajnl\/vdae150","type":"journal-article","created":{"date-parts":[[2024,8,28]],"date-time":"2024-08-28T08:00:07Z","timestamp":1724832007000},"source":"Crossref","is-referenced-by-count":1,"title":["Lisavanbulin (BAL101553), a novel microtubule inhibitor, plus radiation in patients with newly diagnosed, MGMT promoter unmethylated glioblastoma"],"prefix":"10.1093","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3285-3484","authenticated-orcid":false,"given":"Matthias","family":"Holdhoff","sequence":"first","affiliation":[{"name":"The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins , Baltimore, Maryland ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaobu","family":"Ye","sequence":"additional","affiliation":[{"name":"The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins , Baltimore, Maryland ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roy E","family":"Strowd","sequence":"additional","affiliation":[{"name":"Wake Forest University School of Medicine , Winston-Salem, North Carolina ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Burt","family":"Nabors","sequence":"additional","affiliation":[{"name":"University of Alabama , Birmingham, Alabama 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