2023
Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma
Petrylak D, Eigl B, George S, Heath E, Hotte S, Chism D, Nabell L, Picus J, Cheng S, Appleman L, Sonpavde G, Morgans A, Pourhosseini P, Wu R, Standley L, Croitoru R, Yu E. Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma. Clinical Cancer Research 2023, 30: of1-of11. PMID: 37861407, PMCID: PMC10767306, DOI: 10.1158/1078-0432.ccr-22-3627.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaObjective response rateDose-limiting toxicityAntibody-drug conjugatesUrothelial carcinomaCommon treatment-emergent adverse eventsInvestigational antibody-drug conjugateTreatment-emergent adverse eventsI dose-escalation studyDose-expansion cohortsCheckpoint inhibitor therapyPhase II doseDose-escalation studyDose-proportional mannerMultiple-dose administrationBest overall responseMonomethyl auristatin ECytotoxic drug monomethyl auristatin EPrior chemotherapyAdverse eventsDose escalationInhibitor therapyPeripheral neuropathyOcular toxicityExpansion trial
2011
Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in taxane-refractory prostate cancer.
Petrylak D, Kantoff P, Rotshteyn Y, Israel R, Olson W, Ramakrishna T, Morris S. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in taxane-refractory prostate cancer. Journal Of Clinical Oncology 2011, 29: 158-158. DOI: 10.1200/jco.2011.29.7_suppl.158.Peer-Reviewed Original ResearchMonomethyl auristatin EFree MMAEProstate cancer cellsProstate cancerRefractory metastatic prostate cancerDose-proportional PKTaxane-containing regimenCommon laboratory abnormalitiesDose-proportional mannerPhase I trialCancer cellsClinical disease progressionMetastatic prostate cancerOngoing phase IEnzyme-linked immunosorbent assay (ELISA) methodPotential clinical utilityImmunosorbent assay (ELISA) methodECOG statusAdverse eventsEscalation studyLaboratory abnormalitiesI trialThird dosesAntibody therapyLiquid chromatography/mass spectrometry/mass spectrometry method