Pasotuxizumab, a BiTE® immune therapy for castration-resistant prostate cancer: phase I, dose-escalation study findings
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) pasotuxi...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
February 2021
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| In: |
Immunotherapy
Year: 2021, Jahrgang: 13, Heft: 2, Pages: 125-141 |
| ISSN: | 1750-7448 |
| DOI: | 10.2217/imt-2020-0256 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: https://doi.org/10.2217/imt-2020-0256 Verlag, kostenfrei, Volltext: https://www.futuremedicine.com/doi/10.2217/imt-2020-0256 |
| Verfasserangaben: | Horst-Dieter Hummel, Peter Kufer, Carsten Grüllich, Ruth Seggewiss-Bernhardt, Barbara Deschler-Baier, Manik Chatterjee, Maria-Elisabeth Goebeler, Kurt Miller, Maria de Santis, Wolfgang Loidl, Christian Dittrich, Andreas Buck, Constantin Lapa, Annette Thurner, Sabine Wittemer-Rump, Gökben Koca, Oliver Boix, Wolf-Dietrich Döcke, Ricarda Finnern, Helena Kusi, Antoinette Ajavon-Hartmann, Sabine Stienen, Cyrus Michael Sayehli, Bülent Polat & Ralf C Bargou |
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| 245 | 1 | 0 | |a Pasotuxizumab, a BiTE® immune therapy for castration-resistant prostate cancer |b phase I, dose-escalation study findings |c Horst-Dieter Hummel, Peter Kufer, Carsten Grüllich, Ruth Seggewiss-Bernhardt, Barbara Deschler-Baier, Manik Chatterjee, Maria-Elisabeth Goebeler, Kurt Miller, Maria de Santis, Wolfgang Loidl, Christian Dittrich, Andreas Buck, Constantin Lapa, Annette Thurner, Sabine Wittemer-Rump, Gökben Koca, Oliver Boix, Wolf-Dietrich Döcke, Ricarda Finnern, Helena Kusi, Antoinette Ajavon-Hartmann, Sabine Stienen, Cyrus Michael Sayehli, Bülent Polat & Ralf C Bargou |
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| 520 | |a 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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