2021
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, Pook D, Appleman L, Waterhouse D, Horvath L, Edenfield W, Matsubara N, Danila D, Aggarwal R, Petrylak D, Sartor A, Sumey C, Adra N, Armstrong A, Cheng F, Stieglmaier J, Kouros-Mehr H, Dorff T. 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 2021, 39: tps183-tps183. DOI: 10.1200/jco.2021.39.6_suppl.tps183.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerFirst doseImmune therapyProstate cancerECOG performance status 0Prostate-specific antigen (PSA) responseCastration-resistant prostate cancerT cell-mediated lysisDose-expansion phasePerformance status 0Phase 2 doseObjective tumor responseT effector cellsASCO Annual MeetingTotal serum testosteroneLogistic regression modelsCell surface antigensTransmembrane epithelial antigenTumor cell responseCNS metastasisLeptomeningeal diseaseRECIST 1.1Status 0Taxane regimensHormonal therapy
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
LBA55 Initial results from TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients (Pts) with metastatic urothelial cancer (mUC) after failure of platinum-based regimens (PLT) or immunotherapy
Tagawa S, Balar A, Petrylak D, Grivas P, Agarwal N, Sternberg C, Hong Q, Gladden A, Kanwal C, Siemon-Hryczyk P, Goswami T, Itri L, Loriot Y. LBA55 Initial results from TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients (Pts) with metastatic urothelial cancer (mUC) after failure of platinum-based regimens (PLT) or immunotherapy. Annals Of Oncology 2019, 30: v890-v891. DOI: 10.1093/annonc/mdz394.049.Peer-Reviewed Original ResearchMetastatic urothelial cancerPlatinum-based regimensBristol-Myers SquibbSacituzumab govitecanCheckpoint inhibitorsTrial conductionScientific Advisory BoardSeattle GeneticsBavarian NordicEMD SeronoCohort 1Phase II open-label studyPhase I/II studyECOG performance status 0Boehringer IngelheimPre-planned interim analysisHigh unmet medical needClovis OncologyTreatment-related AEsAntitumor activityOpen-label studyPerformance status 0Significant clinical activitySingle-agent chemotherapyTreatment-related deaths