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Pasotuxizumab, a BiTE® immune therapy for castration-resistant prostate cancer: Phase I, dose-escalation study findings.
Hummel, Horst-Dieter; Kufer, Peter; Grüllich, Carsten; Seggewiss-Bernhardt, Ruth; Deschler-Baier, Barbara; Chatterjee, Manik; Goebeler, Maria-Elisabeth; Miller, Kurt; de Santis, Maria; Loidl, Wolfgang; Dittrich, Christian; Buck, Andreas; Lapa, Constantin; Thurner, Annette; Wittemer-Rump, Sabine; Koca, Gökben; Boix, Oliver; Döcke, Wolf-Dietrich; Finnern, Ricarda; Kusi, Helena; Ajavon-Hartmann, Antoinette; Stienen, Sabine; Sayehli, Cyrus Michael; Polat, Bülent; Bargou, Ralf C.
Afiliação
  • Hummel HD; Translational Oncology/Early Clinical Trial Unit (ECTU), Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, Oberdürrbacherstr. 6, 97080 Würzburg, Germany.
  • Kufer P; Research and Development, Amgen Research Munich GmbH, Staffelseestr. 2, 81477, Munich, Germany.
  • Grüllich C; Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Medical Center, Heidelberg, Germany; & Department of Oncology & Hematology, University Hospital Dresden, Haus 27, Fetscherstr. 74, 01307 Dresden, Germany.
  • Seggewiss-Bernhardt R; Translational Oncology/Early Clinical Trial Unit (ECTU), Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, Oberdürrbacherstr. 6, 97080 Würzburg, Germany.
  • Deschler-Baier B; Medizinische Klinik V, Sozialstiftung Bamberg, Buger Str. 80, 96049, Bamberg, Germany.
  • Chatterjee M; Translational Oncology, Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, Josef-Schneider-Str. 6, 97080 Würzburg, Germany.
  • Goebeler ME; Translational Oncology/Early Clinical Trial Unit (ECTU), Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, Oberdürrbacherstr. 6, 97080 Würzburg, Germany.
  • Miller K; Translational Oncology/Early Clinical Trial Unit (ECTU), Medizinische Klinik II, University Hospital Würzburg, Oberdürrbacherstr. 6, 97080 Würzburg, Germany.
  • de Santis M; Department of Urology, Charité Universitätsmedizin Berlin, Charitéplatz. 1, 10117, Berlin, Germany.
  • Loidl W; Department of Urology, Charité Universitätsmedizin Berlin, Charitéplatz. 1, 10117, Berlin, Germany.
  • Dittrich C; Department of Urology, Medical University Vienna, Währinger Gürtel 18-20; 1090 Vienna, Austria.
  • Buck A; Department of Urology, Ordensklinikum Linz GmbH Elisabethinen, Fadingerstr. 1, 4020, Linz, Austria.
  • Lapa C; Applied Cancer Research-Institution for Translational Research Vienna (ACR-ITR VIEnna) & Center for Oncology & Hematology, Kaiser Franz Josef-Spital, Bernardgasse 24/2, 1070, Vienna, Austria.
  • Thurner A; Department of Nuclear Medicine, University Hospital Würzburg, Oberdürrbacherstr. 6, D-97080, Würzburg, Germany.
  • Wittemer-Rump S; Department of Nuclear Medicine, University Hospital Würzburg, Oberdürrbacherstr. 6, D-97080, Würzburg, Germany.
  • Koca G; Nuclear Medicine, Medical Faculty, University of Augsburg, Stenglinstr. 2, 86156 Augsburg, Germany.
  • Boix O; Department of Diagnostic & Interventional Radiology, University Hospital Würzburg, Oberdürrbacherstr. 6, 97080, Würzburg, Germany.
  • Döcke WD; Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
  • Finnern R; Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
  • Kusi H; Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
  • Ajavon-Hartmann A; Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
  • Stienen S; Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
  • Sayehli CM; Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
  • Polat B; Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
  • Bargou RC; Research and Development, Amgen Research Munich GmbH, Staffelseestr. 2, 81477, Munich, Germany.
Immunotherapy ; 13(2): 125-141, 2021 02.
Article em En | MEDLINE | ID: mdl-33172323
Aim: We report results of a first-in-human study of pasotuxizumab, a PSMA bispecific T-cell engager (BiTE®) immune therapy mediating T-cell killing of tumor cells in patients with advanced castration-resistant prostate cancer. Patients & methods: We assessed once-daily subcutaneous (SC) pasotuxizumab. All SC patients developed antidrug antibodies; therefore, continuous intravenous (cIV) infusion was assessed. Results: A total of 47 patients received pasotuxizumab (SC: n = 31, 0.5-172 µg/d; cIV: n = 16, 5-80 µg/d). The SC maximum tolerated dose was 172.0 µg/d. A sponsor change stopped the cIV cohort early; maximum tolerated dose was not determined. PSA responders occurred (>50% PSA decline: SC, n = 9; cIV, n = 3), including two long-term responders. Conclusion: Data support pasotuxizumab safety in advanced castration-resistant prostate cancer and represent evidence of BiTE monotherapy efficacy in solid tumors. Clinical trial registration: NCT01723475 (ClinicalTrials.gov).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Anticorpos Biespecíficos / Neoplasias de Próstata Resistentes à Castração / Antineoplásicos Imunológicos Tipo de estudo: Diagnostic_studies Limite: Aged / Aged80 / Humans / Male / Middle aged Idioma: En Revista: Immunotherapy Assunto da revista: ALERGIA E IMUNOLOGIA / TERAPEUTICA Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Alemanha
Texto completo
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Anticorpos Biespecíficos / Neoplasias de Próstata Resistentes à Castração / Antineoplásicos Imunológicos Tipo de estudo: Diagnostic_studies Limite: Aged / Aged80 / Humans / Male / Middle aged Idioma: En Revista: Immunotherapy Assunto da revista: ALERGIA E IMUNOLOGIA / TERAPEUTICA Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Alemanha