2015
First-in-human multicenter phase I study of BMS-936561 (MDX-1203), an antibody-drug conjugate targeting CD70
Owonikoko TK, Hussain A, Stadler WM, Smith DC, Kluger H, Molina AM, Gulati P, Shah A, Ahlers CM, Cardarelli PM, Cohen LJ. First-in-human multicenter phase I study of BMS-936561 (MDX-1203), an antibody-drug conjugate targeting CD70. Cancer Chemotherapy And Pharmacology 2015, 77: 155-162. PMID: 26576779, DOI: 10.1007/s00280-015-2909-2.Peer-Reviewed Original ResearchConceptsAdverse eventsECOG performance status 0Active drug levelsGrade 3 hypersensitivityMulticenter phase IPerformance status 0Prior chemotherapy regimensFrequent adverse eventsDose-proportional increaseAdvanced ccRCCEligible patientsStatus 0Chemotherapy regimensDisease stabilizationExpansion cohortDose escalationMedian agePK analysisDrug levelsPharmacokinetic samplesB-NHLTitration designHigh doseDose levelsPatients
2009
Pharmacokinetics (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