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
2012
Activity of cabozantinib (XL184) in metastatic NSCLC: Results from a phase II randomized discontinuation trial (RDT).
Hellerstedt B, Edelman G, Vogelzang N, Kluger H, Yasenchak C, Shen X, Ramies D, Gordon M, Lara P. Activity of cabozantinib (XL184) in metastatic NSCLC: Results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2012, 30: 7514-7514. DOI: 10.1200/jco.2012.30.15_suppl.7514.Peer-Reviewed Original ResearchObjective tumor regressionMedian PFSTumor regressionWk 12Median age 67 yearsOverall disease control ratePost-baseline tumour assessmentPrior exposureActivity of cabozantinibDisease control rateGrade 3/4 AEsGrade 5 AEsMedian prior linesAge 67 yearsStudy days 1Dysregulation of METMET upregulationNSCLC ptsPrior EGFRPrior erlotinibRECIST responseTherapy 50Eligible patientsMeasurable diseaseMetastatic NSCLCActivity of cabozantinib (XL184) in metastatic melanoma: Results from a phase II randomized discontinuation trial (RDT).
Gordon M, Kluger H, Shapiro G, Kurzrock R, Edelman G, Samuel T, Moussa A, Ramies D, Laird A, Schimmoller F, Shen X, Daud A. Activity of cabozantinib (XL184) in metastatic melanoma: Results from a phase II randomized discontinuation trial (RDT). Journal Of Clinical Oncology 2012, 30: 8531-8531. DOI: 10.1200/jco.2012.30.15_suppl.8531.Peer-Reviewed Original ResearchProgression-free survivalMedian progression-free survivalObjective tumor regressionTumor regressionPost-baseline tumour assessmentMedian age 66 yearsActivity of cabozantinibGrade 3/4 AEsGrade 5 AEsMedian prior linesOpen-label leadAge 66 yearsStudy days 1BRAF mutation statusMeasurable diseaseDiverticular perforationEligible patientsPrimary endpointFree survivalPain reliefPrior linesMonth 6VEGFR-TKIDiscontinuation trialSafety profile