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 cellsApo2L/TRAIL pharmacokinetics in a phase 1a trial in advanced cancer and lymphoma
Ling J, Herbst R, Mendelson D, Eckhardt S, O’Dwyer P, Ebbinghaus S, Osborne R, Cheu M, Lieberman G, Lum B. Apo2L/TRAIL pharmacokinetics in a phase 1a trial in advanced cancer and lymphoma. Journal Of Clinical Oncology 2006, 24: 3047-3047. DOI: 10.1200/jco.2006.24.18_suppl.3047.Peer-Reviewed Original ResearchApo2L/TRAILCohort 1PK dataSerum concentrationsCohort 2Preclinical modelsRecombinant human Apo2L/TRAILPhase 1a studyPhase 1a trialMild liver dysfunctionNon-compartmental analysisTumor xenograft modelSensitive ELISA assayLiver dysfunctionLiver metastasesPK assessmentAdvanced cancerHepatic metastasesIV infusionNonclinical modelsHematologic cancersXenograft modelClinical developmentDay 1Dose levels
2002
Phase I study of recombinant human endostatin in patients with advanced solid tumors.
Herbst RS, Hess KR, Tran HT, Tseng JE, Mullani NA, Charnsangavej C, Madden T, Davis DW, McConkey DJ, O’Reilly M, Ellis LM, Pluda J, Hong WK, Abbruzzese JL. Phase I study of recombinant human endostatin in patients with advanced solid tumors. Journal Of Clinical Oncology 2002, 20: 3792-803. PMID: 12228199, DOI: 10.1200/jco.2002.11.061.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAngiogenesis InhibitorsCollagenCollagen Type XVIIIEndostatinsEndothelial Growth FactorsE-SelectinFemaleFibroblast Growth Factor 2Hematologic DiseasesHumansImmunoglobulinsInfusions, IntravenousLymphokinesMagnetic Resonance ImagingMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPeptide FragmentsRecombinant ProteinsTime FactorsTissue DistributionVascular Cell Adhesion Molecule-1Vascular Endothelial Growth Factor AVascular Endothelial Growth FactorsConceptsRh-EndoConcentration-time curveRecombinant human endostatinSerum markersPreclinical modelsSolid tumorsHuman endostatinDose-limiting toxic effectAntitumor activityTwo-compartmental open modelAdvanced solid tumorsPhase I trialCentral line accessDose-finding trialMinor antitumor activityI trialIntravenous bolusSerum biomarkersSerum antibodiesPharmacokinetic dispositionAllergic reactionsPatientsPharmacokinetic profileDose levelsPhase I