2021
First-in-human, phase I study of PF-06753512, a vaccine-based immunotherapy regimen (PrCa VBIR), in biochemical relapse (BCR) and metastatic castration-resistant prostate cancer (mCRPC).
Autio K, Higano C, Nordquist L, Appleman L, Zhang T, Zhu X, Babiker H, Vogelzang N, Prasad S, Schweizer M, Billotte S, Binder J, Cavazos N, Li R, Chan K, Cho H, Dermyer M, Hollingsworth R, Kern K, Petrylak D. First-in-human, phase I study of PF-06753512, a vaccine-based immunotherapy regimen (PrCa VBIR), in biochemical relapse (BCR) and metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2021, 39: 2612-2612. DOI: 10.1200/jco.2021.39.15_suppl.2612.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreatment-related adverse eventsImmune checkpoint inhibitorsBiochemical relapseImmune responseCastration-resistant prostate cancerPhase INovel hormone therapyAntitumor activityManageable safety profileObjective tumor responsePD-1 antibodyAntigen-specific immunityProstate-specific membrane antigenAndrogen-sensitive diseaseReplication-deficient adenoviral vectorAnti-tumor activityStem cell antigenPC-associated antigensNoticeable antitumor activityAntibody tremelimumabExpansion doseCheckpoint inhibitorsImmunotherapy regimenAdverse events
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
2019
Mature results from EV-101: A phase I study of enfortumab vedotin in patients with metastatic urothelial cancer (mUC).
Rosenberg J, Sridhar S, Zhang J, Smith D, Ruether J, Flaig T, Baranda J, Lang J, Plimack E, Sangha R, Heath E, Merchan J, Quinn D, Srinivas S, Milowsky M, Wu C, Gartner E, Melhem-Bertrandt A, Petrylak D. Mature results from EV-101: A phase I study of enfortumab vedotin in patients with metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2019, 37: 377-377. DOI: 10.1200/jco.2019.37.7_suppl.377.Peer-Reviewed Original ResearchMetastatic urothelial cancerTreatment-related AEsLiver metastasesMedian followUrothelial cancerPrimary tumor siteUnmet medical needMedian PFSPrior chemotherapyMonotherapy studiesMedian durationPoor prognosisCombination therapyPlatinum chemotherapyMature resultsDay 1Nectin-4Medical needTumor siteSecondary objectivePhase IAntitumor activityEncouraging responseSurvival dataChemotherapy
2017
A phase I study of enfortumab vedotin (ASG-22CE; ASG-22ME): Updated analysis of patients with metastatic urothelial cancer.
Petrylak D, Perez R, Zhang J, Smith D, Ruether J, Sridhar S, Sangha R, Lang J, Heath E, Merchan J, Gartner E, Chu R, Anand B, Doñate F, Jackson L, Adams J, Melhem-Bertrandt A, Rosenberg J. A phase I study of enfortumab vedotin (ASG-22CE; ASG-22ME): Updated analysis of patients with metastatic urothelial cancer. Journal Of Clinical Oncology 2017, 35: 106-106. DOI: 10.1200/jco.2017.35.15_suppl.106.Peer-Reviewed Original ResearchTreatment-related adverse eventsMetastatic urothelial cancerOverall response rateNectin-4 expressionUrothelial cancerAntitumor activityMost treatment-related adverse eventsImmune checkpoint inhibitor therapyMedian progression-free survivalPhase IPrior chemotherapy regimenTreatment-related deathsCheckpoint inhibitor therapyMedian treatment durationFavorable tolerability profilePost-baseline assessmentProgression-free survivalUrinary tract infectionAnalysis of patientsMonomethyl auristatin EDifferent dose levelsArchival tumor specimensAntibody-drug conjugatesEvaluable ptsPrior therapy
2016
788P Interim analysis of a phase I dose escalation trial of ASG-22CE (ASG-22ME; enfortumab vedotin), an antibody drug conjugate (ADC), in patients (Pts) with metastatic urothelial cancer (mUC)
Rosenberg J, Heath E, Perez R, Merchan J, Lang J, Ruether D, Petrylak D, Sangha R, Smith D, Sridhar S, Gartner E, Vincent M, Chu R, Anand B, Donate F, Melhem-Bertrandt A, Zhang J. 788P Interim analysis of a phase I dose escalation trial of ASG-22CE (ASG-22ME; enfortumab vedotin), an antibody drug conjugate (ADC), in patients (Pts) with metastatic urothelial cancer (mUC). Annals Of Oncology 2016, 27: vi273. DOI: 10.1093/annonc/mdw373.16.Peer-Reviewed Original Research780PD Interim analysis of a phase I dose escalation trial of the antibody drug conjugate (ADC) AGS15E (ASG-15ME) in patients (Pts) with metastatic urothelial cancer (mUC)
Petrylak D, Heath E, Sonpavde G, George S, Morgans A, Eigl B, Picus J, Cheng S, Hotte S, Gartner E, Vincent M, Chu R, Anand B, Morrison K, Jackson L, Melhem-Bertrandt A, Yu E. 780PD Interim analysis of a phase I dose escalation trial of the antibody drug conjugate (ADC) AGS15E (ASG-15ME) in patients (Pts) with metastatic urothelial cancer (mUC). Annals Of Oncology 2016, 27: vi269. DOI: 10.1093/annonc/mdw373.08.Peer-Reviewed Original ResearchAnti-tumor activity, safety and pharmacokinetics (PK) of AGS15E (ASG-15ME) in a phase I dose escalation trial in patients (Pts) with metastatic urothelial cancer (mUC).
Petrylak D, Heath E, Sonpavde G, George S, Morgans A, Eigl B, Picus J, Cheng S, Hotte S, Gartner E, Vincent M, Chu R, Anand B, Morrison K, Jackson L, Reyno L, Yu E. Anti-tumor activity, safety and pharmacokinetics (PK) of AGS15E (ASG-15ME) in a phase I dose escalation trial in patients (Pts) with metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2016, 34: 4532-4532. DOI: 10.1200/jco.2016.34.15_suppl.4532.Peer-Reviewed Original ResearchAnti-tumor activity, safety and pharmacokinetics (PK) of ASG-22CE (ASG-22ME; enfortumab vedotin) in a phase I dose escalation trial in patients (Pts) with metastatic urothelial cancer (mUC).
Rosenberg J, Heath E, Van Veldhuizen P, Merchan J, Lang J, Ruether J, Petrylak D, Sangha R, Smith D, Sridhar S, Gartner E, Vincent M, Chu R, Anand B, Donate F, Jackson L, Reyno L, Zhang J. Anti-tumor activity, safety and pharmacokinetics (PK) of ASG-22CE (ASG-22ME; enfortumab vedotin) in a phase I dose escalation trial in patients (Pts) with metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2016, 34: 4533-4533. DOI: 10.1200/jco.2016.34.15_suppl.4533.Peer-Reviewed Original Research
2009
Final results of a phase I study of oral belinostat (PXD101) in patients with lymphoma
Zain J, Foss F, Kelly W, DeBono J, Petrylak D, Narwal A, Neylon E, Blumenschein G, Lassen U, O'Connor O. Final results of a phase I study of oral belinostat (PXD101) in patients with lymphoma. Journal Of Clinical Oncology 2009, 27: 8580-8580. DOI: 10.1200/jco.2009.27.15_suppl.8580.Peer-Reviewed Original ResearchNon-Hodgkin lymphomaHodgkin's diseaseDose escalationTumor shrinkageSolid tumorsIntra-patient dose escalationRefractory non-Hodgkin lymphomaPhase IAcceptable organ functionEarly tumor shrinkageMedian age 51Frequent adverse eventsPossible dose escalationMantle cell lymphomaHistone deacetylase inhibitorsEvaluable diseaseLeg DVTPrior regimensQ3w scheduleStable diseaseAdverse eventsDaily doseSafety profileCohort C.Preclinical activity
2008
404 POSTER A phase I study of oral administration of the histone deacetylase (HDAC) inhibitor belinostat in patients (pts) with advanced solid tumors
Kelly W, Petrylak D, Blumenschein G, Lassen U, Jensen P, DeBono J. 404 POSTER A phase I study of oral administration of the histone deacetylase (HDAC) inhibitor belinostat in patients (pts) with advanced solid tumors. European Journal Of Cancer Supplements 2008, 6: 127. DOI: 10.1016/s1359-6349(08)72338-3.Peer-Reviewed Original ResearchLONG TERM CLINICAL OUTCOME OF A PHASE I TRIAL OF INTRAVESICAL DOCETAXEL IN THE MANAGEMENT OF SUPERFICIAL BLADDER CANCER REFRACTORY TO STANDARD INTRAVESICAL THERAPY
Laudano M, Murphy A, Petrylak D, Desai M, Benson M, McKiernan J. LONG TERM CLINICAL OUTCOME OF A PHASE I TRIAL OF INTRAVESICAL DOCETAXEL IN THE MANAGEMENT OF SUPERFICIAL BLADDER CANCER REFRACTORY TO STANDARD INTRAVESICAL THERAPY. Journal Of Urology 2008, 179: 121. DOI: 10.1016/s0022-5347(08)60345-6.Peer-Reviewed Original Research
2006
139 POSTER Phase I dose escalation safety/tolerance study of PPl-2458 in subjects with Non-Hodgkin's lymphoma or solid tumors
Stiede K, Eder J, Anthony S, Conkling P, Fayad L, Petrylak D, Sausville E, Verschraegen C, Bhat G. 139 POSTER Phase I dose escalation safety/tolerance study of PPl-2458 in subjects with Non-Hodgkin's lymphoma or solid tumors. European Journal Of Cancer Supplements 2006, 4: 45. DOI: 10.1016/s1359-6349(06)70145-8.Peer-Reviewed Original Research