PMID- 33172323
OWN - NLM
STAT- MEDLINE
DCOM- 20220209
LR  - 20240229
IS  - 1750-7448 (Electronic)
IS  - 1750-743X (Linking)
VI  - 13
IP  - 2
DP  - 2021 Feb
TI  - Pasotuxizumab, a BiTE((R)) immune therapy for castration-resistant prostate cancer: 
      Phase I, dose-escalation study findings.
PG  - 125-141
LID - 10.2217/imt-2020-0256 [doi]
AB  - Aim: We report results of a first-in-human study of pasotuxizumab, a PSMA 
      bispecific T-cell engager (BiTE((R))) 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 mug/d; cIV: n = 16, 5-80 mug/d). The SC maximum 
      tolerated dose was 172.0 mug/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).
FAU - Hummel, Horst-Dieter
AU  - Hummel HD
AD  - Translational Oncology/Early Clinical Trial Unit (ECTU), Comprehensive Cancer 
      Center Mainfranken, University Hospital Wurzburg, Oberdurrbacherstr. 6, 97080 
      Wurzburg, Germany.
FAU - Kufer, Peter
AU  - Kufer P
AD  - Research and Development, Amgen Research Munich GmbH, Staffelseestr. 2, 81477, 
      Munich, Germany.
FAU - Grullich, Carsten
AU  - Grullich C
AD  - 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.
FAU - Seggewiss-Bernhardt, Ruth
AU  - Seggewiss-Bernhardt R
AD  - Translational Oncology/Early Clinical Trial Unit (ECTU), Comprehensive Cancer 
      Center Mainfranken, University Hospital Wurzburg, Oberdurrbacherstr. 6, 97080 
      Wurzburg, Germany.
AD  - Medizinische Klinik V, Sozialstiftung Bamberg, Buger Str. 80, 96049, Bamberg, 
      Germany.
FAU - Deschler-Baier, Barbara
AU  - Deschler-Baier B
AD  - Translational Oncology, Comprehensive Cancer Center Mainfranken, University 
      Hospital Wurzburg, Josef-Schneider-Str. 6, 97080 Wurzburg, Germany.
FAU - Chatterjee, Manik
AU  - Chatterjee M
AUID- ORCID: 0000-0001-7854-5543
AD  - Translational Oncology/Early Clinical Trial Unit (ECTU), Comprehensive Cancer 
      Center Mainfranken, University Hospital Wurzburg, Oberdurrbacherstr. 6, 97080 
      Wurzburg, Germany.
FAU - Goebeler, Maria-Elisabeth
AU  - Goebeler ME
AD  - Translational Oncology/Early Clinical Trial Unit (ECTU), Medizinische Klinik II, 
      University Hospital Wurzburg, Oberdurrbacherstr. 6, 97080 Wurzburg, Germany.
FAU - Miller, Kurt
AU  - Miller K
AD  - Department of Urology, Charite Universitatsmedizin Berlin, Chariteplatz. 1, 
      10117, Berlin, Germany.
FAU - de Santis, Maria
AU  - de Santis M
AD  - Department of Urology, Charite Universitatsmedizin Berlin, Chariteplatz. 1, 
      10117, Berlin, Germany.
AD  - Department of Urology, Medical University Vienna, Wahringer Gurtel 18-20; 1090 
      Vienna, Austria.
FAU - Loidl, Wolfgang
AU  - Loidl W
AD  - Department of Urology, Ordensklinikum Linz GmbH Elisabethinen, Fadingerstr. 1, 
      4020, Linz, Austria.
FAU - Dittrich, Christian
AU  - Dittrich C
AD  - 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.
FAU - Buck, Andreas
AU  - Buck A
AUID- ORCID: 0000-0002-6447-0613
AD  - Department of Nuclear Medicine, University Hospital Wurzburg, Oberdurrbacherstr. 
      6, D-97080, Wurzburg, Germany.
FAU - Lapa, Constantin
AU  - Lapa C
AD  - Department of Nuclear Medicine, University Hospital Wurzburg, Oberdurrbacherstr. 
      6, D-97080, Wurzburg, Germany.
AD  - Nuclear Medicine, Medical Faculty, University of Augsburg, Stenglinstr. 2, 86156 
      Augsburg, Germany.
FAU - Thurner, Annette
AU  - Thurner A
AD  - Department of Diagnostic & Interventional Radiology, University Hospital 
      Wurzburg, Oberdurrbacherstr. 6, 97080, Wurzburg, Germany.
FAU - Wittemer-Rump, Sabine
AU  - Wittemer-Rump S
AD  - Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
FAU - Koca, Gokben
AU  - Koca G
AD  - Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
FAU - Boix, Oliver
AU  - Boix O
AUID- ORCID: 0000-0003-3704-0877
AD  - Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
FAU - Docke, Wolf-Dietrich
AU  - Docke WD
AD  - Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
FAU - Finnern, Ricarda
AU  - Finnern R
AD  - Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
FAU - Kusi, Helena
AU  - Kusi H
AD  - Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
FAU - Ajavon-Hartmann, Antoinette
AU  - Ajavon-Hartmann A
AD  - Bayer AG, SBU Oncology, Pharmaceuticals, 13353, Berlin, Germany.
FAU - Stienen, Sabine
AU  - Stienen S
AD  - Research and Development, Amgen Research Munich GmbH, Staffelseestr. 2, 81477, 
      Munich, Germany.
FAU - Sayehli, Cyrus Michael
AU  - Sayehli CM
AD  - Translational Oncology/Early Clinical Trial Unit (ECTU), Medizinische Klinik II, 
      University Hospital Wurzburg, Oberdurrbacherstr. 6, 97080 Wurzburg, Germany.
FAU - Polat, Bulent
AU  - Polat B
AUID- ORCID: 0000-0003-4677-424X
AD  - Department of Radiation Oncology, University Hospital Wurzburg, 
      Josef-Schneider-Str. 11, 97080, Wurzburg, Germany.
FAU - Bargou, Ralf C
AU  - Bargou RC
AUID- ORCID: 0000-0002-1221-7421
AD  - Translational Oncology, Comprehensive Cancer Center Mainfranken, University 
      Hospital Wurzburg, Josef-Schneider-Str. 6, 97080 Wurzburg, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT01723475
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20201110
PL  - England
TA  - Immunotherapy
JT  - Immunotherapy
JID - 101485158
RN  - 0 (Antibodies, Bispecific)
RN  - 0 (Antigens, Surface)
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (CD3 Complex)
RN  - EC 3.4.17.21 (FOLH1 protein, human)
RN  - EC 3.4.17.21 (Glutamate Carboxypeptidase II)
RN  - 0 (Pasotuxizumab)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Antibodies, Bispecific/immunology/pharmacokinetics/therapeutic use
MH  - Antigens, Surface/immunology
MH  - *Antineoplastic Agents, Immunological/immunology/pharmacokinetics/therapeutic use
MH  - Biomarkers, Tumor/blood
MH  - CD3 Complex/immunology
MH  - Glutamate Carboxypeptidase II/immunology
MH  - Immunotherapy
MH  - Infusions, Intravenous
MH  - Injections, Subcutaneous
MH  - Maximum Tolerated Dose
MH  - *Prostatic Neoplasms, Castration-Resistant/blood/immunology/pathology/therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - AMG 212
OT  - BAY 2010112
OT  - PSMA
OT  - bispecific T-cell engager (BiTE(R)) immune therapy
OT  - pasotuxizumab
OT  - prostate cancer
EDAT- 2020/11/12 06:00
MHDA- 2022/02/09 06:00
CRDT- 2020/11/11 05:34
PHST- 2020/11/12 06:00 [pubmed]
PHST- 2022/02/09 06:00 [medline]
PHST- 2020/11/11 05:34 [entrez]
AID - 10.2217/imt-2020-0256 [doi]
PST - ppublish
SO  - Immunotherapy. 2021 Feb;13(2):125-141. doi: 10.2217/imt-2020-0256. Epub 2020 Nov 
      10.