2010
A Phase I Safety and Pharmacokinetic Study of the Death Receptor 5 Agonistic Antibody PRO95780 in Patients with Advanced Malignancies
Camidge DR, Herbst RS, Gordon MS, Eckhardt SG, Kurzrock R, Durbin B, Ing J, Tohnya TM, Sager J, Ashkenazi A, Bray G, Mendelson D. A Phase I Safety and Pharmacokinetic Study of the Death Receptor 5 Agonistic Antibody PRO95780 in Patients with Advanced Malignancies. Clinical Cancer Research 2010, 16: 1256-1263. PMID: 20145186, DOI: 10.1158/1078-0432.ccr-09-1267.Peer-Reviewed Original ResearchConceptsAdvanced malignanciesGrade 3 transaminase elevationHuman IgG1 monoclonal antibodyPhase I safetyDose-escalation designDose-dependent increaseDeath receptor 5Different tumor typesIgG1 monoclonal antibodyCohort expansionTransaminase elevationI safetyMost patientsObjective responseTrough concentrationsAdverse eventsEscalation designMultiple dosesMinor responseEfficacious concentrationsOvarian cancerEvidence of activityPharmacokinetic analysisReceptor 5Human studies
2007
A phase I safety and pharmacokinetic study of apomab, a human DR5 agonist antibody, in patients with advanced cancer
Camidge D, Herbst R, Gordon M, Eckhardt S, Kurzroc R, Durbin B, Ing J, Ling J, Sager J, Mendelson D. A phase I safety and pharmacokinetic study of apomab, a human DR5 agonist antibody, in patients with advanced cancer. Journal Of Clinical Oncology 2007, 25: 3582-3582. DOI: 10.1200/jco.2007.25.18_suppl.3582.Peer-Reviewed Original ResearchTreatment-refractory solid tumorsPhase I safetyColorectal cancer patientsPre-clinical dataEvidence of benefitDR5 agonist antibodyAnti-cancer efficacyIgG1 monoclonal antibodyAsymptomatic transaminitisCohort expansionECOG PSHAHA responseUnacceptable toxicityI safetyObjective responseSymptomatic improvementAdvanced cancerCancer patientsMinor responseReceptor agonistTarget lesionsApomabDisease progressionEfficacy dataPreclinical models
2006
A phase I safety and pharmacokinetic (PK) study of recombinant Apo2L/TRAIL, an apoptosis-inducing protein in patients with advanced cancer
Herbst R, Mendolson D, Ebbinghaus S, Gordon M, O’Dwyer P, Lieberman G, Ing J, Kurzrock R, Novotny W, Eckhardt G. A phase I safety and pharmacokinetic (PK) study of recombinant Apo2L/TRAIL, an apoptosis-inducing protein in patients with advanced cancer. Journal Of Clinical Oncology 2006, 24: 3013-3013. DOI: 10.1200/jco.2006.24.18_suppl.3013.Peer-Reviewed Original ResearchAdvanced solid tumorsLiver metastasesSolid tumorsHematologic malignanciesApo2L/TRAILRecombinant human Apo2L/TRAILPost-baseline tumour assessmentPhase I safetyObjective partial responseFurther dose optimizationAttributable toxicityStable diseaseAdult patientsI safetyPartial responseAdvanced cancerCommon diagnosisRandomized trialsStandard treatmentReceptor agonistOvarian cancerPreclinical modelsSafety dataTumor assessmentMost normal cells