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
2020
Phase I study of AMG 509, a STEAP1 x CD3 T cell-recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC).
Kelly W, Danila D, Edenfield W, Aggarwal R, Petrylak D, Sartor A, Sumey C, Dorff T, Yu E, Adra N, Waterhouse D, Armstrong A, Horvath L, Pook D, Appleman L, Lau A, Salvati M, Kouros-Mehr H. Phase I study of AMG 509, a STEAP1 x CD3 T cell-recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2020, 38: tps5589-tps5589. DOI: 10.1200/jco.2020.38.15_suppl.tps5589.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerFirst doseImmune therapyProstate cancerECOG performance status 0Prostate-specific antigen (PSA) responseCastration-resistant prostate cancerT cell-mediated lysisPhase IDose-expansion phasePerformance status 0Objective tumor responsePhase II doseT effector cellsTotal serum testosteroneLogistic regression modelsCell surface antigensTransmembrane epithelial antigenTumor cell responseCNS metastasisLeptomeningeal diseaseRECIST 1.1Status 0Taxane regimensHormonal therapy
1999
Phase I trial of docetaxel with estramustine in androgen-independent prostate cancer.
Petrylak D, Macarthur R, O'Connor J, Shelton G, Judge T, Balog J, Pfaff C, Bagiella E, Heitjan D, Fine R, Zuech N, Sawczuk I, Benson M, Olsson C. Phase I trial of docetaxel with estramustine in androgen-independent prostate cancer. Journal Of Clinical Oncology 1999, 17: 958-67. PMID: 10071290, DOI: 10.1200/jco.1999.17.3.958.Peer-Reviewed Original ResearchConceptsAndrogen-independent prostate cancerEPT patientsProstate cancerMPT patientsProgressive metastatic androgen-independent prostate cancerMetastatic androgen-independent prostate cancerDose-limiting myelosuppressionGrade 3/4 granulocytopeniaPSA response ratePhase II doseDoses of docetaxelPhase I trialPharmacokinetics of docetaxelBone painMeasurable diseaseOral estramustinePo tidPain medicationPartial responseSerum PSAI trialNarcotic analgesicsTime of entryPatientsDay 1