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
2013
Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane.
Petrylak D, Kantoff P, Mega A, Vogelzang N, Stephenson J, Fleming M, Stambler N, Petrini M, Blattman S, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane. Journal Of Clinical Oncology 2013, 31: 5018-5018. DOI: 10.1200/jco.2013.31.15_suppl.5018.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenProgressive metastatic castration-resistant prostate cancerMonomethyl auristatin ELiver function testsFree MMAEPhase 1 dose-escalation studyCastration-resistant prostate cancerTaxane-containing chemotherapyAntitumor activityDose-escalation studyPhase 2 trialPhase I trialCancer cellsProstate cancer cellsSpecific membrane antigenECOG statusLFT abnormalitiesPrior docetaxelAdverse eventsEscalation studyI trialPeripheral neuropathyAntibody therapyFunction testsPhase Ib extension study of eribulin mesylate in combination with carboplatin in patients with chemotherapy-naive advanced non-small cell lung cancer (NSCLC).
Raftopoulos H, Aisner J, Kumar K, Goel S, Dittrich C, Jain M, Gopalakrishna P, Salazar P, Jones B, Petrylak D. Phase Ib extension study of eribulin mesylate in combination with carboplatin in patients with chemotherapy-naive advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: e19145-e19145. DOI: 10.1200/jco.2013.31.15_suppl.e19145.Peer-Reviewed Original ResearchAdvanced non-small cell lung cancerNon-small cell lung cancerDisease control rateProgression-free survivalDuration of responseChemo-naïve patientsAdverse eventsOverall survivalEribulin mesylateDay 1Platinum-based doublet chemotherapyOverall objective response rateCarboplatin AUC 6Combination of eribulinCommon adverse eventsObjective response rateUnexpected safety findingsDose-escalation studyCell lung cancerLung cancer cell linesAUC 6Doublet chemotherapyFebrile neutropeniaMeasurable diseaseCancer cell linesProstate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane.
Petrylak D, Kantoff P, Mega A, Vogelzang N, Stephenson J, Fleming M, Stambler N, Petrini M, Huang K, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane. Journal Of Clinical Oncology 2013, 31: 119-119. DOI: 10.1200/jco.2013.31.6_suppl.119.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenMonomethyl auristatin EFree MMAEProstate cancer cellsProgressive metastatic castration-resistant prostate cancerDose levelsPhase 1 dose-escalation studyLiver function test elevationsCastration-resistant prostate cancerTaxane-containing chemotherapyAntitumor activityDose-escalation studyPhase 2 trialPhase I trialCancer cellsClinical disease progressionHighest dose levelSpecific membrane antigenECOG statusLFT abnormalitiesPrior docetaxelAdverse eventsEscalation studyI trial
2012
Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane.
Mega A, Petrylak D, Kantoff P, Stephenson J, Vogelzang N, Dreicer R, Shore N, Stambler N, Carpenito J, D'Ambrosio P, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane. Journal Of Clinical Oncology 2012, 30: 4662-4662. DOI: 10.1200/jco.2012.30.15_suppl.4662.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerMonomethyl auristatin EHighest dose levelFree MMAEProstate cancer cellsDose levelsAdverse eventsProgressive metastatic castration-resistant prostate cancerPhase 1 dose-escalation studyCastration-resistant prostate cancerTumor cellsHigh-dose cohortTaxane-containing chemotherapyAntitumor activityCommon laboratory abnormalitiesDose-escalation studyLiver function testsPhase I trialCancer cellsClinical disease progressionDose cohortsECOG statusEscalation studyLaboratory abnormalitiesDose escalationProstate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in men with prostate cancer previously treated with taxane.
Petrylak D, Kantoff P, Mega A, Dreicer R, Frank R, Shore N, Morris S, Olson W, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in men with prostate cancer previously treated with taxane. Journal Of Clinical Oncology 2012, 30: 107-107. DOI: 10.1200/jco.2012.30.5_suppl.107.Peer-Reviewed Original ResearchMonomethyl auristatin EFree MMAEProstate cancer cellsAdverse eventsProstate cancerMetastatic castration-resistant prostate cancerPhase 1 dose-escalation studyCastration-resistant prostate cancerTumor cellsHigh-dose cohortTaxane-containing regimenAntitumor activityCommon laboratory abnormalitiesDose-escalation studyPhase I trialCancer cellsClinical disease progressionHighest dose levelBone painDose cohortsECOG statusEscalation studyLaboratory abnormalitiesI trialThird doses