A phase I/II study of CR011-vcMMAE, an antibody-drug conjugate (ADC) targeting glycoprotein NMB (GPNMB) in patients (pts) with advanced melanoma
Hwu P, Sznol M, Pavlick A, Kluger H, Kim K, Boasberg P, Sanders D, Simantov R, Crowley E, Hamid O. A phase I/II study of CR011-vcMMAE, an antibody-drug conjugate (ADC) targeting glycoprotein NMB (GPNMB) in patients (pts) with advanced melanoma. Journal Of Clinical Oncology 2009, 27: 9032-9032. DOI: 10.1200/jco.2009.27.15_suppl.9032.Peer-Reviewed Original ResearchProgression-free survivalCR011-vcMMAEPartial responseAntibody-drug conjugatesGlycoprotein NMBMonomethylauristatin EAdvanced melanomaPhase I/II studyCommon grade 3/4 AEsMedian progression-free survivalLonger progression-free survivalUnconfirmed partial responseUnresectable stage IIIStage IV melanomaDuration of responseOverall responseHuman monoclonal antibodyPhase II dataCytotoxic regimenEligible ptsCommon AEsIntolerable toxicityPrimary endpointSecondary endpointsFree survivalPharmacokinetics (PK) of CR011-vcMMAE, an antibody-drug conjugate (ADC), in a phase (Ph) I study of patients (pts) with advanced melanoma
Sznol M, Hamid O, Hwu P, Kluger H, Hawthorne T, Crowley E, Simantov R, Pavlick A. Pharmacokinetics (PK) of CR011-vcMMAE, an antibody-drug conjugate (ADC), in a phase (Ph) I study of patients (pts) with advanced melanoma. Journal Of Clinical Oncology 2009, 27: 9063-9063. DOI: 10.1200/jco.2009.27.15_suppl.9063.Peer-Reviewed Original ResearchAntibody-drug conjugatesCR011-vcMMAETotal AbAdverse eventsMean maximum plasma concentrationNoncompartmental PK analysisCommon adverse eventsMaximum plasma concentrationEnzyme-linked immunosorbent assayQ3w scheduleQW scheduleII trialWeekly dosingAdvanced melanomaDose escalationDose scheduleCumulative dosesPK analysisPlasma concentrationsBreast cancerImmunosorbent assayPhase IPharmacokineticsPH IQ3w