{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T00:47:05Z","timestamp":1785113225276,"version":"3.55.0"},"reference-count":44,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"32","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2014,11,10]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> The antibody-drug conjugate glembatumumab vedotin links a fully human immunoglobulin G2 monoclonal antibody against the melanoma-related glycoprotein NMB (gpNMB) to the potent cytotoxin monomethyl auristatin E. This study evaluated the safety and activity of glembatumumab vedotin in patients with advanced melanoma. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Patients received glembatumumab vedotin every 3 weeks (schedule 1) in a dose escalation and phase II expansion at the maximum-tolerated dose (MTD). Dosing during 2 of 3 weeks (schedule 2) and weekly (schedule 3) was also assessed. The primary end points were safety and pharmacokinetics. The secondary end points included antitumor activity, gpNMB expression, and immunogenicity. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> One hundred seventeen patients were treated using schedule 1 (n = 79), schedule 2 (n = 15), or schedule 3 (n = 23). The MTDs were 1.88, 1.5, and 1.0 mg\/kg for schedules 1, 2, and 3, respectively. Grade 3\/4 treatment-related toxicities that occurred in two or more patients included rash, neutropenia, fatigue, neuropathy, arthralgia, myalgia, and diarrhea. Three treatment-related deaths (resulting from pneumococcal sepsis, toxic epidermal necrolysis, and renal failure) occurred at doses exceeding the MTDs. In the schedule 1 phase II expansion cohort (n = 34), five patients (15%) had a partial response and eight patients (24%) had stable disease for \u2265 6 months. The objective response rate (ORR) was 2 of 6 (33%) for the schedule 2 MTD and 3 of 12 (25%) for the schedule 3 MTD. Rash was correlated with a greater ORR and improved progression-free survival. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Glembatumumab vedotin is active in advanced melanoma. The schedule 1 MTD (1.88 mg\/kg once every 3 weeks) was associated with a promising ORR and was generally well tolerated. More frequent dosing was potentially associated with a greater ORR but increased toxicity. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2013.54.8115","type":"journal-article","created":{"date-parts":[[2014,9,30]],"date-time":"2014-09-30T03:18:40Z","timestamp":1412047120000},"page":"3659-3666","source":"Crossref","is-referenced-by-count":85,"title":["Phase I\/II Study of the Antibody-Drug Conjugate Glembatumumab Vedotin in Patients With Advanced Melanoma"],"prefix":"10.1200","volume":"32","author":[{"given":"Patrick A.","family":"Ott","sequence":"first","affiliation":[{"name":"Patrick A. Ott and Anna C. Pavlick, New York University Cancer Institute, New York, NY; Omid Hamid and Peter D. Boasberg, The Angeles Clinic and Research Institute, Los Angeles, CA; Harriet Kluger and Mario Sznol, Yale Cancer Center, New Haven, CT; Kevin B. Kim and Patrick Hwu, University of Texas MD Anderson Cancer Center, Houston, TX; Ronit Simantov, Elizabeth Crowley, Jennifer A. 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