Clinical trial • Phase II/III • Oncology

IZALONTAMAB BRENGITECAN for Metastatic urothelial cancer

Phase II/III trial of IZALONTAMAB BRENGITECAN for Metastatic urothelial cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic urothelial cancer
Trial Stage
Phase II/III
Drug Modality
ADC|Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
29-08-2025
First CTIS Authorization Date
19-12-2025

Trial design

Randomised, open-label, platinum-based chemotherapy (pbc) comparators listed: gemcitabine (product gemcitabine; max daily 1000 mg/m2; max total 6000 mg/m2; intravenous use), cisplatin (max daily 70 mg/m2; max total 420 mg/m2; intravenous use), carboplatin (product listed; intravenous use; dose not specified in part i data).-controlled, adaptive Phase II/III trial in Spain, Czechia, Austria and others.

Randomised
Yes
Open Label
Yes
Comparator
Platinum-based chemotherapy (PBC) comparators listed: GEMCITABINE (product gemcitabine; max daily 1000 mg/m2; max total 6000 mg/m2; intravenous use), CISPLATIN (max daily 70 mg/m2; max total 420 mg/m2; intravenous use), CARBOPLATIN (product listed; intravenous use; dose not specified in Part I data).
Adaptive
Yes
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
254

Eligibility

Recruits 254 No vulnerable population selected; participants are adults (no paediatric population indicated) and standard informed consent procedures apply (country-specific subject information and informed consent forms are provided)..

Vulnerable Population
No vulnerable population selected; participants are adults (no paediatric population indicated) and standard informed consent procedures apply (country-specific subject information and informed consent forms are provided).

Inclusion criteria

  • {"criterion_text":"- People with a metastatic urothelial cancer, confirmed by looking at tissue or cell samples, whose disease has worsened on or after an immunotherapy-based treatment.\n- To be eligible for this trial, patients must have not been treated previously with more than two types of systemic cancer treatment.\n- To be part of this study, the patient's cancer must have grown or come back after being treated with a type of medicine (also known as anti-PD-(L)1 therapy) that helps the body's immune system fight cancer. It could have been used alone or with other treatments, but patients must have had at least one other treatment in addition to the anti-PD-(L)1 therapy. However, if the patient only had this therapy for a type of bladder cancer that has not spread to other parts of the body, they can't be part of this study.\n- Also, if the patient had anti-PD-(L)1 therapy as part of their surgery preparation or recovery, they may be eligible to participate if certain other conditions are met.\n- The study also involves a treatment called PBC, which uses drugs called cisplatin or carboplatin. So, patients need to be able to take these drugs."}

Exclusion criteria

  • {"criterion_text":"- If patients have had a treatment with PBC before, they need to have stopped taking them for at least a year to be part of this study.\n- Patients who did not respond well to previous PBC treatments, meaning their cancer did not shrink or were stable for less than 6 months, can't join this study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Phase 2: Will be assessed by reviewing all available data, including efficacy, safety, tolerability, and pharmacokinetic data.\n- Phase 3: Efficacy will be evaluated by comparing progression-free survival (time from start of treatment until worsening of disease or death, whichever comes first) and overall survival (how long a patient lives) between iza-bren and PBC.","definition_or_measurement_approach":"Phase 2: Assessment by review of all available data including efficacy, safety, tolerability and pharmacokinetic data. Phase 3: Efficacy measured by progression-free survival (defined as time from start of treatment until worsening of disease or death, whichever comes first) and overall survival (time from randomisation/start of treatment until death from any cause); comparison between iza-bren and platinum-based chemotherapy (PBC)."}

Secondary endpoints

  • {"endpoint_text":"- Phase 2 and 3: Additional efficacy endpoints will be tested in both groups of patients, including what proportion of participants respond to treatment (objective response rate), how long until participants respond to treatment (time to response), how long a participants’ response to treatment lasts (duration of response), time without cancer growing (progression free survival) and how long patients survive (overall survival).\n- In Phase 3 only, the time it takes for participants to report a decline in their quality of life will be measured and compared.","definition_or_measurement_approach":"Phase 2 & 3 additional efficacy endpoints: objective response rate (proportion of participants with tumour response), time to response, duration of response, progression-free survival, overall survival. Phase 3 only: time to reported decline in quality of life (measured and compared between arms)."}

Recruitment

Planned Sample Size
254
Recruitment Window Months
47
Consent Approach
Informed consent obtained using subject information and informed consent forms (country-specific L1 SIS and ICF documents are provided). Separate forms/materials for pregnant participants and partners and optional future research are available in multiple countries; consent is via standard ICF process as per country-specific documentation.

Geography

Total Number Of Sites
66
Total Number Of Participants
207

Spain

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
91
Number Of Sites
11
Number Of Participants
44

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Jose Angel Arranz
Principal Investigator Email
xxxx@xxx.com
Contact Person Name
Jose Angel Arranz
Contact Person Email
xxxx@xxx.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Principal Investigator Name
Ignacio Duran
Principal Investigator Email
xxxxx@xxx.com
Contact Person Name
Ignacio Duran
Contact Person Email
xxxxx@xxx.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Principal Investigator Name
Jose Pablo Maroto
Principal Investigator Email
jmaroto@santpau.cat
Contact Person Name
Jose Pablo Maroto
Contact Person Email
jmaroto@santpau.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Begoña Perez
Principal Investigator Email
xxxx@xxx.com
Contact Person Name
Begoña Perez
Contact Person Email
xxxx@xxx.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Pablo Gajate
Principal Investigator Email
xxxxx@xxx.com
Contact Person Name
Pablo Gajate
Contact Person Email
xxxxx@xxx.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
MªJose Mendez
Principal Investigator Email
mj.mendez.sspa@juntadeandalucia.es
Contact Person Name
MªJose Mendez
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Castellano Daniel
Principal Investigator Email
xxxx@xxx.com
Contact Person Name
Castellano Daniel
Contact Person Email
xxxx@xxx.com
Site Name
Hospital Universitario De Badajoz
Department Name
Oncology
Principal Investigator Name
Marta Gonzalez
Principal Investigator Email
marta.gonzalezc@salud-juntaex.es
Contact Person Name
Marta Gonzalez
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Principal Investigator Name
Javier Puente
Principal Investigator Email
jpuente@salud.madrid.org
Contact Person Name
Javier Puente
Contact Person Email
jpuente@salud.madrid.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Rafael Morales
Principal Investigator Email
morales@vhio.net
Contact Person Name
Rafael Morales
Contact Person Email
morales@vhio.net
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Juan-Fita MªJose
Principal Investigator Email
mjjuan@fivo.org
Contact Person Name
Juan-Fita MªJose
Contact Person Email
mjjuan@fivo.org

Czechia

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
22
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Onkologicka klinika 2. LF UK a FN Motol
Principal Investigator Name
Tomas Buchler
Principal Investigator Email
tomas.buchler@fnmotol.cz
Contact Person Name
Tomas Buchler
Contact Person Email
tomas.buchler@fnmotol.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie
Principal Investigator Name
Jindrich Kopecky
Principal Investigator Email
jindrich.kopecky@fnhk.cz
Contact Person Name
Jindrich Kopecky
Contact Person Email
jindrich.kopecky@fnhk.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexni onkologicke pece
Principal Investigator Name
Alexandr Poprach
Principal Investigator Email
alexandr.poprach@mou.cz
Contact Person Name
Alexandr Poprach
Contact Person Email
alexandr.poprach@mou.cz

Austria

Earliest CTIS Part Ii Submission Date
14-11-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
38
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Medical University Of Vienna
Department Name
University Clinic for Urology
Principal Investigator Name
Kilian Gust
Principal Investigator Email
kilian.gust@meduniwien.ac.at
Contact Person Name
Kilian Gust
Contact Person Email
kilian.gust@meduniwien.ac.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
University Clinic for Urology
Principal Investigator Name
Renate Pichler
Principal Investigator Email
renate.pichler@tirol-kliniken.at
Contact Person Name
Renate Pichler
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
1. Medical Department, Center for Oncology and Hematology
Principal Investigator Name
Dora Niedersuess-Beke
Contact Person Name
Dora Niedersuess-Beke

France

Earliest CTIS Part Ii Submission Date
12-12-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
11
Number Of Sites
11
Number Of Participants
35

Sites

Site Name
Centre Jean Perrin
Department Name
Medical oncology
Principal Investigator Name
Hakim MAHAMMEDI
Principal Investigator Email
hakim.mahammedi@clermont.unicancer.fr
Contact Person Name
Hakim MAHAMMEDI
Site Name
Fondation Hopital Saint Joseph
Department Name
Oncology
Principal Investigator Name
Carole HELISSEY
Principal Investigator Email
chelissey@ghpsj.fr
Contact Person Name
Carole HELISSEY
Contact Person Email
chelissey@ghpsj.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Medical Oncology
Principal Investigator Name
Benjamin AUBERGER
Principal Investigator Email
benjamin.auberger@chu-brest.fr
Contact Person Name
Benjamin AUBERGER
Contact Person Email
benjamin.auberger@chu-brest.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Medical oncology
Principal Investigator Name
Constance THIBAULT
Principal Investigator Email
constance.thibault@aphp.fr
Contact Person Name
Constance THIBAULT
Contact Person Email
constance.thibault@aphp.fr
Site Name
Centre Antoine Lacassagne
Department Name
Medical oncology
Principal Investigator Name
Delphine BORCHIELLINI
Principal Investigator Email
delphine.borchiellini@nice.unicancer.fr
Contact Person Name
Delphine BORCHIELLINI
Site Name
Institut Gustave Roussy
Department Name
Department of Early Drug Development and Genitourinary Oncology Group
Principal Investigator Name
Yohan LORIOT
Principal Investigator Email
yohann.loriot@gustaveroussy.fr
Contact Person Name
Yohan LORIOT
Contact Person Email
yohann.loriot@gustaveroussy.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d'oncologie médicale
Principal Investigator Name
Marine GROSS-GOUPIL
Principal Investigator Email
marine.gross-goupil@chu-bordeaux.fr
Contact Person Name
Marine GROSS-GOUPIL
Site Name
Hospital Foch
Department Name
Medical oncology
Principal Investigator Name
Yann-Alexandre VANO
Principal Investigator Email
y.vano@hopital-foch.com
Contact Person Name
Yann-Alexandre VANO
Contact Person Email
y.vano@hopital-foch.com
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Medical Oncology
Principal Investigator Name
Philippe BARTHELEMY
Principal Investigator Email
p.barthelemy@icans.eu
Contact Person Name
Philippe BARTHELEMY
Contact Person Email
p.barthelemy@icans.eu
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Medical oncology
Principal Investigator Name
Frederic ROLLAND
Principal Investigator Email
frederic.rolland@ico.unicancer.fr
Contact Person Name
Frederic ROLLAND
Site Name
Centre Leon Berard
Department Name
Department of Medical Oncology
Principal Investigator Name
Aude FLECHON
Principal Investigator Email
aude.flechon@lyon.unicancer.fr
Contact Person Name
Aude FLECHON
Contact Person Email
aude.flechon@lyon.unicancer.fr

Italy

Earliest CTIS Part Ii Submission Date
10-12-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
13
Number Of Sites
9
Number Of Participants
28

Sites

Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
Dipartimento di Oncologia Medica
Principal Investigator Name
Sebastiano Buti
Principal Investigator Email
sbuti@ao.pr.it
Contact Person Name
Sebastiano Buti
Contact Person Email
sbuti@ao.pr.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncologia
Principal Investigator Name
Marco Maruzzo
Principal Investigator Email
marco.maruzzo@iov.veneto.it
Contact Person Name
Marco Maruzzo
Contact Person Email
marco.maruzzo@iov.veneto.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Unita' Operativa Oncologia Medica 1
Principal Investigator Name
Giuseppe Fornarini
Principal Investigator Email
Giuseppe.Fornarini@hsanmartino.it
Contact Person Name
Giuseppe Fornarini
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
UOC Oncologia Medica Universitaria
Principal Investigator Name
Rizzo Mimma
Principal Investigator Email
controlroom@policlinico.ba.it
Contact Person Name
Rizzo Mimma
Contact Person Email
controlroom@policlinico.ba.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
UOC Oncologia Medica
Principal Investigator Name
Luigi Formisano
Principal Investigator Email
Luigi.formisano1@unina.it
Contact Person Name
Luigi Formisano
Contact Person Email
Luigi.formisano1@unina.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento Oncologia Medica
Principal Investigator Name
Andrea Necchi
Principal Investigator Email
Necchi.andrea@hsr.it
Contact Person Name
Andrea Necchi
Contact Person Email
Necchi.andrea@hsr.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Dipartimento di Oncologia Medica
Principal Investigator Name
Patrizia Giannatempo
Principal Investigator Email
Patrizia.Giannatempo@istitutotumori.mi.it
Contact Person Name
Patrizia Giannatempo
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Dipartimento di Oncologia Medica 1
Principal Investigator Name
Fabio Calabro'
Principal Investigator Email
Fabio.calabro@ifo.it
Contact Person Name
Fabio Calabro'
Contact Person Email
Fabio.calabro@ifo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Oncologia Medica
Principal Investigator Name
Andrea Necchi
Principal Investigator Email
Necchi.andrea@hsr.it
Contact Person Name
Andrea Necchi
Contact Person Email
Necchi.andrea@hsr.it

Belgium

Earliest CTIS Part Ii Submission Date
13-11-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
39
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Ziekenhuis Aan De Stroom
Department Name
Oncology Centre
Principal Investigator Name
Tom Van den Mooter
Principal Investigator Email
tom.vandenmooter@zas.be
Contact Person Name
Tom Van den Mooter
Contact Person Email
tom.vandenmooter@zas.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Medical Oncology
Principal Investigator Name
Pierre Freres
Principal Investigator Email
pfreres@chuliege.be
Contact Person Name
Pierre Freres
Contact Person Email
pfreres@chuliege.be
Site Name
Az Maria Middelares Gent
Department Name
Medical Oncology & hematology
Principal Investigator Name
Christof Vulsteke
Principal Investigator Email
christof.vulsteke@mijnziekenhuis.be
Contact Person Name
Christof Vulsteke
Site Name
Universitair Ziekenhuis Gent
Department Name
Medical Oncology - Drug Research Unit
Principal Investigator Name
Sylvie Rottey
Principal Investigator Email
sylvie.rottey@ugent.be
Contact Person Name
Sylvie Rottey
Contact Person Email
sylvie.rottey@ugent.be

Ireland

Earliest CTIS Part Ii Submission Date
28-11-2025
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
42
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Cork University Hospital
Department Name
Medical Oncology
Principal Investigator Name
Richard Bambury
Principal Investigator Email
Richard.bambury@hse.ie
Contact Person Name
Richard Bambury
Contact Person Email
Richard.bambury@hse.ie
Site Name
Tallaght University Hospital
Department Name
Medical Oncology
Principal Investigator Name
Ray McDermott
Principal Investigator Email
ray.mcdermott@tuh.ie
Contact Person Name
Ray McDermott
Contact Person Email
ray.mcdermott@tuh.ie

Norway

Earliest CTIS Part Ii Submission Date
05-12-2025
Latest Decision Or Authorization Date
19-12-2025
Processing Time Days
14
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Akershus University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Khanh Minh Vu
Principal Investigator Email
khanh.Minh.Vu@ahus.no
Contact Person Name
Khanh Minh Vu
Contact Person Email
khanh.Minh.Vu@ahus.no
Site Name
Sykehuset Oestfold HF Kalnes
Department Name
Department of Oncology
Principal Investigator Name
Corina Emilia Idu
Principal Investigator Email
corina.emilia.idu@so-hf.no
Contact Person Name
Corina Emilia Idu
Contact Person Email
corina.emilia.idu@so-hf.no
Site Name
Sykehuset I Vestfold HF
Department Name
Clinical Trial Unit/Center for Cancer and blood diseases
Principal Investigator Name
Marius Taran
Principal Investigator Email
matara@siv.no
Contact Person Name
Marius Taran
Contact Person Email
matara@siv.no

Sweden

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
05-03-2026
Processing Time Days
100
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO Hematologi, Onkologi och Strålningsfysik, Jan Waldenströmsgata 18 205 02 Malmö
Principal Investigator Name
Olof Ståhl
Principal Investigator Email
olof.stahl@skane.se
Contact Person Name
Olof Ståhl
Contact Person Email
olof.stahl@skane.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Verksamhet Onkologi, Blå Stråket 2, 413 45 Göteborg
Principal Investigator Name
Emma Mangelus
Principal Investigator Email
emma.mangelus@vgregion.se
Contact Person Name
Emma Mangelus
Contact Person Email
emma.mangelus@vgregion.se
Site Name
Karolinska University Hospital
Department Name
Urologisk onkologi, Akademiska straket 13, 171 76 Stockholm
Principal Investigator Name
Anders Ullén
Principal Investigator Email
anders.ullen@regionstockholm.se
Contact Person Name
Anders Ullén

Romania

Earliest CTIS Part Ii Submission Date
11-09-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
119
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncology
Principal Investigator Name
Tudor Ciuleanu
Principal Investigator Email
office@iocn.ro
Contact Person Name
Tudor Ciuleanu
Contact Person Email
office@iocn.ro
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncology
Principal Investigator Name
Michael Schenker
Principal Investigator Email
mike_schenker@yahoo.com
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com
Site Name
Institutul Regional De Oncologie Iasi
Department Name
Oncology
Principal Investigator Name
Teodora-Alexa Stratulat
Principal Investigator Email
teodora_alexa@yahoo.com
Contact Person Name
Teodora-Alexa Stratulat
Contact Person Email
teodora_alexa@yahoo.com

Germany

Earliest CTIS Part Ii Submission Date
22-10-2025
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
133
Number Of Sites
14
Number Of Participants
37

Sites

Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Principal Investigator Name
Philipp Ivanyi
Principal Investigator Email
ivanyi.philipp@mh-hannover.de
Contact Person Name
Philipp Ivanyi
Contact Person Email
ivanyi.philipp@mh-hannover.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Urologische Klinik und Poliklinik
Principal Investigator Name
Margitta Retz
Principal Investigator Email
margitta.retz@tum.de
Contact Person Name
Margitta Retz
Contact Person Email
margitta.retz@tum.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Urologie, Campus Benjamin Franklin
Principal Investigator Name
Maria de Santis
Principal Investigator Email
maria.de-santis@charite.de
Contact Person Name
Maria de Santis
Contact Person Email
maria.de-santis@charite.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Campus Kiel, Klinik für Urologie
Principal Investigator Name
Severin Rodler
Principal Investigator Email
severin.rodler@uksh.de
Contact Person Name
Severin Rodler
Contact Person Email
severin.rodler@uksh.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Principal Investigator Name
Stefanie Zschaebitz
Principal Investigator Email
stefanie.zschaebitz@med.uni-heidelberg.de
Contact Person Name
Stefanie Zschaebitz
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Urologie und Kinderurologie
Principal Investigator Name
Friedemann Zengerling
Principal Investigator Email
friedemann.zengerling@uniklinik-ulm.de
Contact Person Name
Friedemann Zengerling
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum für Onkologie, II. Medizinische Klinik und Poliklinik
Principal Investigator Name
Gunhild von Amsberg
Principal Investigator Email
g.von-amsberg@uke.de
Contact Person Name
Gunhild von Amsberg
Contact Person Email
g.von-amsberg@uke.de
Site Name
Klinikum Nuernberg
Department Name
Ambulantes BehandlungsCentrum, Campus Nord
Principal Investigator Name
Marinela Augustin
Principal Investigator Email
marinela.augustin@klinikum-nuernberg.de
Contact Person Name
Marinela Augustin
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Klinik für Urologie
Principal Investigator Name
Florian Roghmann
Principal Investigator Email
florian.roghmann@elisabethgruppe.de
Contact Person Name
Florian Roghmann
Site Name
University Medical Center Regensburg AöR
Department Name
Klinik für Urologie
Principal Investigator Name
Marco Schnabel
Principal Investigator Email
mschnabel@csj.de
Contact Person Name
Marco Schnabel
Contact Person Email
mschnabel@csj.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Urologische Klinik und Poliklinik
Principal Investigator Name
Marc-Oliver Grimm
Principal Investigator Email
marc-oliver.grimm@med.uni-jena.de
Contact Person Name
Marc-Oliver Grimm
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Department Name
Studienpraxis Urologie
Principal Investigator Name
Tilman Todenhoefer
Principal Investigator Email
todenhoefer@studienurologie.de
Contact Person Name
Tilman Todenhoefer
Contact Person Email
todenhoefer@studienurologie.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Uroonkologischen Zentrum
Principal Investigator Name
Guenter Niegisch
Principal Investigator Email
guenter.niegisch@med.uni-duesseldorf.de
Contact Person Name
Guenter Niegisch

Sponsor

Primary sponsor

Full Name
Bristol-Myers Squibb Services Unlimited Company
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
PPD Development LP
Responsibilities
serology / endocrinology/ medical image analysis / review - X-ray, MRI, ultrasound, etc.
Name
Endpoint Clinical Inc.
Responsibilities
IVRS - treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment
Name
Clario
Responsibilities
Medical image analysis/ review - X-ray, MRI, ultrasound, etc.; Customer Care / Site Logistics / Training / Equipment Customization
Name
Accenture Services Pvt. Ltd.
Responsibilities
Pharmacovigilance duties: Medical review and Cases Data Entry
Name
Labcorp Central Laboratory Services LP
Responsibilities
Routine clinical pathology testing, clinical chemistry, clinical hematology, clinical microbiology, IHC Biomarker expression analysis (PD-L1), other APH
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Tumor blocks/slides storage, PGX spl, spl storage for vendors, IHC, Legacy LabCorp Central Lab; Routine clinical pathology testing, clinical chemistry, clinical hematology, clinical microbiology

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Routine clinical pathology testing, clinical chemistry, clinical hematology, clinical microbiology, IHC Biomarker expression analysis (PD-L1), other APH","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"serology / endocrinology/ medical image analysis / review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Services Pvt. Ltd.","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"SME"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS - treatment randomisation, Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Health care"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Tumor blocks/slides storage, PGX spl, spl storage for vendors, IHC, Legacy LabCorp Central Lab; Routine clinical pathology testing, clinical chemistry, clinical hematology, clinical microbiology","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.; Customer Care / Site Logistics / Training / Equipment Customization","organisation_type":"Health care"}

Investigational products

Investigational Product Name
BL-B01D1
Active Substance
IZALONTAMAB BRENGITECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Maximum Dose
70 mg/m2 (max daily); 420 mg/m2 (max total)
Investigational Product Name
GEMCITABINE
Active Substance
GEMCITABINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Maximum Dose
1000 mg/m2 (max daily); 6000 mg/m2 (max total)
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Investigational Product Name
PEGFILGRASTIM
Active Substance
PEGFILGRASTIM
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Combination Treatment
Yes

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