Clinical trial • Phase II/III • Oncology

DATOPOTAMAB DERUXTECAN for Locally advanced or metastatic urothelial carcinoma

Phase II/III trial of DATOPOTAMAB DERUXTECAN for Locally advanced or metastatic urothelial carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Locally advanced or metastatic urothelial carcinoma
Trial Stage
Phase II/III
Drug Modality
ADC | Small molecule

Key dates

Initial CTIS Submission Date
25-06-2025
First CTIS Authorization Date
15-10-2025

Trial design

Randomised, open-label, gemcitabine plus cisplatin or carboplatin (gemcitabine [ribozar] up to 1000 mg/m2; cisplatin [cisplatin hikma] up to 70 mg/m2; carboplatin [carboplatin hikma] up to 750 mg) — schedule not specified in the ctis record.-controlled Phase II/III trial in Italy, Norway, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Gemcitabine plus Cisplatin or Carboplatin (Gemcitabine [Ribozar] up to 1000 mg/m2; Cisplatin [Cisplatin Hikma] up to 70 mg/m2; Carboplatin [Carboplatin Hikma] up to 750 mg) — schedule not specified in the CTIS record.
Target Sample Size
306

Eligibility

Recruits 306 Vulnerable population selected in the CTIS record. Inclusion criteria restrict to adults ("Adult ≥18 years at the time the ICF is signed."). Specific informed consent documents for pregnant participants/partners are included in the submission (documents titled for example 'L1_SIS and ICF Pregnant Partner', 'L1_DS1062-328_Pregnant Participant ICF' and country-specific ICFs). No assent procedures for minors are described..

Vulnerable Population
Vulnerable population selected in the CTIS record. Inclusion criteria restrict to adults ("Adult ≥18 years at the time the ICF is signed."). Specific informed consent documents for pregnant participants/partners are included in the submission (documents titled for example 'L1_SIS and ICF Pregnant Partner', 'L1_DS1062-328_Pregnant Participant ICF' and country-specific ICFs). No assent procedures for minors are described.

Inclusion criteria

  • {"criterion_text":"- Adult ≥18 years at the time the ICF is signed."}
  • {"criterion_text":"- Histologically or cytologically confirmed unresectable locally advanced or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra."}
  • {"criterion_text":"- Must provide tumor tissue sample from archival tissue or newly obtained pretreatment biopsy for exploratory biomarker testing."}
  • {"criterion_text":"- Participant must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator’s judgment."}
  • {"criterion_text":"- Must have experienced radiographic progression or relapse during or after 1L of enfortumab vedotin (EV) and pembrolizumab. Participant who discontinued EV and pembrolizumab in 1L due to toxicity are eligible if they have experienced disease progression following discontinuation."}
  • {"criterion_text":"- Measurable disease on CT/MRI per RECIST version 1.1 as assessed by investigator."}
  • {"criterion_text":"- ECOG PS of 0 or 1."}
  • {"criterion_text":"- Has required baseline laboratory data: adequate bone marrow function, adequate renal function, adequate hepatic function, and adequate blood clotting function."}

Exclusion criteria

  • {"criterion_text":"- Has had prior systemic therapy other than the combination of EV and pembrolizumab for la/mUC."}
  • {"criterion_text":"- Has had treatment with any of the following: History of an allogeneic bone marrow or solid organ transplant, concomitant treatment with any prohibited medications in the protocol, prior TROP2 directed ADC therapy."}
  • {"criterion_text":"- Uncontrolled or significant cardiovascular disease."}
  • {"criterion_text":"- Has a history of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening."}
  • {"criterion_text":"- Has clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses."}
  • {"criterion_text":"- Has toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline. Participants may be enrolled with chronic, stable Grade 2 toxicities which the investigator deems related to previous anticancer therapy."}
  • {"criterion_text":"- History of severe hypersensitivity to either the drug or inactive ingredients of Dato-DXd, platinum (i.e., both carboplatin and cisplatin), or gemcitabine."}
  • {"criterion_text":"- Has an uncontrolled infection requiring systemic therapy"}
  • {"criterion_text":"- Has clinically significant corneal disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Phase 2: ORR, assessed by investigator assessment using RECIST Version 1.1 criteria: defined as the proportion of participants with a BOR of confirmed CR or confirmed PR.","definition_or_measurement_approach":"Overall response rate (ORR) assessed by investigator using RECIST v1.1; defined as proportion of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR)."}
  • {"endpoint_text":"- Phase 3: PFS, determined by BICR assessment of tumor scans and using RECIST Version 1.1 criteria, defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"Progression-free survival (PFS) determined by Blinded Independent Central Review (BICR) using RECIST v1.1; time from randomization to first documented radiographic progression or death from any cause."}
  • {"endpoint_text":"- Phase 3: OS, defined as the time from randomization to death due to any cause.","definition_or_measurement_approach":"Overall survival (OS); time from randomization to death due to any cause."}

Secondary endpoints

  • {"endpoint_text":"- Phase 2: DoR, assessed by investigator assessment using RECIST Version 1.1 criteria, defined as the time from the date of first documentation of objective tumor response (confirmed CR or confirmed PR) to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first in responding participants.","definition_or_measurement_approach":"Duration of response (DoR) by investigator per RECIST v1.1; time from first documentation of objective response to radiographic progression or death."}
  • {"endpoint_text":"- Phase 2: PFS, determined by investigator assessment of tumor scans and using RECIST Version 1.1 criteria, defined as the time interval from the date of randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"PFS by investigator per RECIST v1.1; time from randomization to progression or death."}
  • {"endpoint_text":"- Phase 2: OS is defined as the time from randomization to death due to any cause.","definition_or_measurement_approach":"OS; time from randomization to death from any cause."}
  • {"endpoint_text":"- Phase 2: TTR, assessed by investigator assessment using RECIST Version 1.1 criteria, defined as the time from randomization to the date of the first documentation of objective tumor response (confirmed CR or confirmed PR) in responding participants.","definition_or_measurement_approach":"Time to response (TTR) by investigator per RECIST v1.1; time from randomization to first documentation of objective tumor response."}
  • {"endpoint_text":"- Phase 2: DCR, assessed by investigator assessment using RECIST Version 1.1 criteria, is defined as proportion of participants with a BOR of confirmed CR, confirmed PR, or SD.","definition_or_measurement_approach":"Disease control rate (DCR) by investigator per RECIST v1.1; proportion with BOR of confirmed CR, confirmed PR, or stable disease (SD)."}
  • {"endpoint_text":"- Phase 2: Incidence of TEAEs, SAEs, AESIs, deaths, and changes from baseline in vital signs, standard clinical laboratory parameters, ECG parameters, ECHO/MUGA scan findings, and ophthalmologic findings.","definition_or_measurement_approach":"Safety endpoints: incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), deaths, and changes in clinical/laboratory/ECG/ECHO/ophthalmologic parameters."}
  • {"endpoint_text":"- Phase 2: ADA incidence.","definition_or_measurement_approach":"Incidence of anti-drug antibodies (ADA)."}
  • {"endpoint_text":"- Phase 2: Characterize population PK of Dato-DXd and DXd and the relationship between exposure and efficacy and safety endpoints.","definition_or_measurement_approach":"Population pharmacokinetics (PK) characterization of Dato-DXd and DXd and exposure-response analyses."}
  • {"endpoint_text":"- Phase 3: PFS, determined by investigator assessment of tumor scans and using RECIST Version 1.1 criteria, is defined as the time interval from the date of randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"Investigator-assessed PFS by RECIST v1.1; time from randomization to progression or death."}
  • {"endpoint_text":"- Phase 3: ORR, assessed by BICR and investigator assessment using RECIST Version 1.1 criteria, is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR.","definition_or_measurement_approach":"ORR assessed by both BICR and investigator per RECIST v1.1; proportion with confirmed CR or PR."}
  • {"endpoint_text":"- Phase 3: DoR, assessed by BICR and investigator assessment using RECIST Version 1.1 criteria, is defined as the time from the date of first documentation of objective tumor response (confirmed CR or confirmed PR) to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first in responding participants.","definition_or_measurement_approach":"DoR by BICR and investigator per RECIST v1.1; time from first response to progression or death."}
  • {"endpoint_text":"- Phase 3: TTR, assessed by BICR and investigator assessment using RECIST Version 1.1 criteria, is defined as the time from randomization to the date of the first documentation of objective tumor response (confirmed CR or confirmed PR) in responding participants.","definition_or_measurement_approach":"TTR by BICR and investigator per RECIST v1.1; time from randomization to first response."}
  • {"endpoint_text":"- Phase 3: DCR, assessed by BICR and investigator assessment using RECIST Version 1.1 criteria, is defined as proportion of participants with a BOR of confirmed CR, confirmed PR, or SD.","definition_or_measurement_approach":"DCR by BICR and investigator per RECIST v1.1; proportion with CR, PR or SD."}
  • {"endpoint_text":"- Phase 3: Incidence of TEAEs, SAEs, AESIs, deaths, and changes from baseline in vital signs, standard clinical laboratory parameters, ECG parameters, ECHO/MUGA scan findings, and ophthalmologic findings.","definition_or_measurement_approach":"Safety endpoints as in Phase 2, assessed by BICR/investigator as appropriate."}
  • {"endpoint_text":"- Phase 3: ADA incidence.","definition_or_measurement_approach":"Incidence of anti-drug antibodies (ADA)."}
  • {"endpoint_text":"- Phase 3: TTCD, defined as time from the date of randomization to the date of confirmed deterioration, and mean change from baseline in the urinary symptoms subscale of the EORTC-QLQ-BLM30.","definition_or_measurement_approach":"Time to confirmed deterioration (TTCD) and mean change from baseline in urinary symptoms subscale of EORTC-QLQ-BLM30."}
  • {"endpoint_text":"- Phase 3: TTCD, defined as time from the date of randomization to the date of confirmed deterioration, and mean change from baseline in GHS/QoL, as measured by the GHS/QoL scale from EORTC-QLQ-C30.","definition_or_measurement_approach":"TTCD and mean change from baseline in global health status/quality of life (GHS/QoL) as measured by EORTC-QLQ-C30."}
  • {"endpoint_text":"- Phase 3: TTCD, defined as time from the date of randomization to the date of confirmed deterioration, and mean change from baseline in physical and role functioning, as measured by the physical functioning and role functioning domains from EORTC-QLQ-C30.","definition_or_measurement_approach":"TTCD and mean change from baseline in physical and role functioning domains of EORTC-QLQ-C30."}

Recruitment

Planned Sample Size
306
Recruitment Window Months
52
Consent Approach
Informed consent obtained from participants (adults ≥18 years) via country-specific ICFs (multiple 'L1_SIS and ICF' documents). Specific consent documents exist for pregnant participants and pregnant partners (documents titled e.g. 'L1_SIS and ICF Pregnant Partner', 'L1_DS1062-328_Pregnant Participant ICF'). ICFs and participant information materials are provided in multiple languages and country-specific versions (examples include English, Italian, Dutch, French, Spanish, German, Greek, Norwegian as evidenced by document manual versions and country associations). No assent for minors is described.

Methods

  • Physician referral letters (documents titled 'K2...Physician Referral Letter' available in country-specific versions) - channel: healthcare professionals; target audience: treating physicians to refer eligible patients; country-specific versions present for multiple Member States.
  • Dr-to-Patient letters (documents titled 'K2...Dr-to-Patient Letter') - channel: information sent via treating physicians to patients; target audience: potential participants; country-specific versions present.
  • Patient brochures / Patient Information Guide (documents titled 'K2...Patient Brochure' or 'L2_Other Subject Information Material_Patient Information Guide') - channel: printed/electronic patient-facing materials; target audience: potential participants; available country-specific translations.
  • Recruitment procedures documents (documents titled 'K1_Recruitment arrangements' or 'K1_Recruitment procedure') describing recruitment workflow at sites.

Geography

Total Number Of Sites
120
Total Number Of Participants
341

Italy

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
30
Number Of Sites
15
Number Of Participants
72

Sites

Site Name
Cliniche Gavazzeni S.p.A.
Department Name
Oncologia
Contact Person Name
Emilia Cocorocchio
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Oncologia Medica
Contact Person Name
Alessandra Mosca
Contact Person Email
alessandra.mosca@ircc.it
Site Name
Istituto Nazionale Tumori Regina Elena
Contact Person Name
Fabio Calabrò
Contact Person Email
fabio.calabro@ifo.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
UOS Trattamenti Innovativi
Contact Person Name
Rosa Tambaro
Contact Person Email
r.tambaro@istitutotumori.na.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
UOC Oncologia AOUI Verona
Contact Person Name
Andrea Zivi
Contact Person Email
andrea.zivi@aovr.veneto.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
UC Oncologia Medica 1
Contact Person Name
Giuseppe Procopio
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UC Oncologia Medica
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it
Site Name
Azienda Socio Sanitaria Territoriale Ovest Milanese
Department Name
UOC Oncologia
Contact Person Name
Andrea Luciani
Contact Person Email
andrea.luciani@asst-ovestmi.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
SCDU Oncologia Medica
Contact Person Name
Consuelo Buttigliero
Contact Person Email
consuelo.buttigliero@unito.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
UO Oncologia/Ematologia
Contact Person Name
Matteo Perrino
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Oncologia II
Contact Person Name
Luca Galli
Contact Person Email
lugal71@yahoo.it
Site Name
Azienda Sanitaria Locale Napoli 2 Nord
Department Name
UOC Oncologia
Contact Person Name
Gaetano Facchini
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
SC Oncologia Medica
Contact Person Name
Annalisa Guida
Contact Person Email
a.guida@aospterni.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Oncologia Medica 1
Contact Person Name
Giuseppe Fornarini
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
UOC Oncologia
Contact Person Name
Alfredo Berruti
Contact Person Email
alfredo.berruti@gmail.com

Norway

Earliest CTIS Part Ii Submission Date
26-09-2025
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
19
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Helse Stavanger HF
Department Name
Oncology
Contact Person Name
Maria Vigmostad
Contact Person Email
marvig@sus.no
Site Name
Sykehuset I Vestfold HF
Department Name
Oncology
Contact Person Name
Marius Taran
Contact Person Email
matara@siv.no
Site Name
Akershus University Hospital
Department Name
Oncology
Contact Person Name
Mohsan Syed
Contact Person Email
mohsan.ali.syed@ahus.no

Netherlands

Earliest CTIS Part Ii Submission Date
26-09-2025
Latest Decision Or Authorization Date
16-10-2025
Processing Time Days
20
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Medical Oncology
Principal Investigator Name
M.D. Franken
Principal Investigator Email
mira.franken@radboudumc.nl
Contact Person Name
M.D. Franken
Contact Person Email
mira.franken@radboudumc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Medical Oncology
Principal Investigator Name
Britt Suelmann
Principal Investigator Email
b.b.m.suelmann@umcutrecht.nl
Contact Person Name
Britt Suelmann
Contact Person Email
b.b.m.suelmann@umcutrecht.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Medical Oncology
Principal Investigator Name
Debbie Robbrecht
Principal Investigator Email
d.robbrecht@erasmusmc.nl
Contact Person Name
Debbie Robbrecht
Contact Person Email
d.robbrecht@erasmusmc.nl

Belgium

Earliest CTIS Part Ii Submission Date
19-01-2026
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
14
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
Az Maria Middelares Gent
Department Name
Medische Oncologie-Hematologie
Principal Investigator Name
Christof Vulsteke
Principal Investigator Email
christof.vulsteke@mijnziekenhuis.be
Contact Person Name
Christof Vulsteke
Site Name
Centre hospitalier universitaire de Liege
Department Name
Medische Oncologie
Principal Investigator Name
Pierre Freres
Principal Investigator Email
pfreres@chuliege.be
Contact Person Name
Pierre Freres
Contact Person Email
pfreres@chuliege.be
Site Name
UZ Leuven
Department Name
Medische Oncologie
Principal Investigator Name
Herlinde Dumez
Principal Investigator Email
herlinde.dumez@uzleuven.be
Contact Person Name
Herlinde Dumez
Contact Person Email
herlinde.dumez@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Medische Oncologie
Principal Investigator Name
Sylvie Rottey
Principal Investigator Email
sylvie.rottey@ugent.be
Contact Person Name
Sylvie Rottey
Contact Person Email
sylvie.rottey@ugent.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Medische Oncologie
Principal Investigator Name
Jan Van den Brande
Principal Investigator Email
jan.vandenbrande@uza.be
Contact Person Name
Jan Van den Brande
Contact Person Email
jan.vandenbrande@uza.be

Czechia

Earliest CTIS Part Ii Submission Date
23-01-2026
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
25
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Onkologická klinika 2.LF UK a FN Motol
Principal Investigator Name
Tomáš Büchler
Principal Investigator Email
tomas.buchler@fnmotol.cz
Contact Person Name
Tomáš Büchler
Contact Person Email
tomas.buchler@fnmotol.cz

Greece

Earliest CTIS Part Ii Submission Date
29-10-2025
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
75
Number Of Sites
10
Number Of Participants
5

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Propaedeutic Department of Internal Medicine
Principal Investigator Name
Aristotelis Bamias
Principal Investigator Email
abamias@med.uoa.gr
Contact Person Name
Aristotelis Bamias
Contact Person Email
abamias@med.uoa.gr
Site Name
Metropolitan Hospital
Department Name
2nd Oncology Clinic
Principal Investigator Name
Konstantinos Koutsoukos
Principal Investigator Email
koutsoukos.k@gmail.com
Contact Person Name
Konstantinos Koutsoukos
Contact Person Email
koutsoukos.k@gmail.com
Site Name
Saint Savvas Oncology Hospital
Department Name
2nd (B’) Department of Internal Medicine - Oncology
Principal Investigator Name
Dimitrios Tryfonopoulos
Principal Investigator Email
tryfonopoulos@hotmail.com
Contact Person Name
Dimitrios Tryfonopoulos
Contact Person Email
tryfonopoulos@hotmail.com
Site Name
Athens Medical Center S.A. (Thessaloniki)
Department Name
3rd Department of Oncology
Principal Investigator Name
Loukas Kontovinis
Principal Investigator Email
l.kontovinis@oncomedicare.com
Contact Person Name
Loukas Kontovinis
Contact Person Email
l.kontovinis@oncomedicare.com
Site Name
General University Hospital Of Larissa
Department Name
Department of Medical Oncology
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
thankotsakis@uth.gr
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@uth.gr
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
Department of Medical Oncology
Principal Investigator Name
Eleni Timotheadou
Principal Investigator Email
timotheadoue@gmail.com
Contact Person Name
Eleni Timotheadou
Contact Person Email
timotheadoue@gmail.com
Site Name
Athens Medical Center S.A. (Maroussi)
Department Name
Department of Medical Oncology
Principal Investigator Name
Marinos Tsiatas
Principal Investigator Email
tsiatas@hotmail.com
Contact Person Name
Marinos Tsiatas
Contact Person Email
tsiatas@hotmail.com
Site Name
General Hospital Of Athens Alexandra
Department Name
Department of Clinical Therapeutics
Principal Investigator Name
Michael Liontos
Principal Investigator Email
mliontos@gmail.com
Contact Person Name
Michael Liontos
Contact Person Email
mliontos@gmail.com
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology
Principal Investigator Name
Angelos Koutras
Principal Investigator Email
angkoutr@otenet.gr
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.gr
Site Name
Theageneio Cancer Hospital
Department Name
3rd Department of Clinical Oncology and Chemotherapy
Principal Investigator Name
Anastasios Boutis
Principal Investigator Email
alboutis@otenet.gr
Contact Person Name
Anastasios Boutis
Contact Person Email
alboutis@otenet.gr

France

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
30
Number Of Sites
33
Number Of Participants
153

Sites

Site Name
Capio La Croix Du Sud
Department Name
Oncology
Contact Person Name
Francesco Ricci
Contact Person Email
francesco.ricci@curie.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Medical Oncology
Principal Investigator Name
Loic Jaffrelot
Principal Investigator Email
Loic.jaffrelot@aphp.fr
Contact Person Name
Loic Jaffrelot
Contact Person Email
Loic.jaffrelot@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Medical Oncology
Principal Investigator Name
Denis Maillet
Principal Investigator Email
Denis.maillet@chu-lyon.fr
Contact Person Name
Denis Maillet
Contact Person Email
Denis.maillet@chu-lyon.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
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
Oncopole Claudius Regaud
Department Name
Medical Oncology
Principal Investigator Name
Damien Pouessel
Principal Investigator Email
Pouessel.damien@iuct-oncopole.fr
Contact Person Name
Damien Pouessel
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Principal Investigator Name
Ileana Corbeau
Principal Investigator Email
Ileana.corbeau@icm.unicancer.fr
Contact Person Name
Ileana Corbeau
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Medical Oncology
Principal Investigator Name
Sheik Emambux
Principal Investigator Email
Sheik.emambux@chu-poitiers.fr
Contact Person Name
Sheik Emambux
Contact Person Email
Sheik.emambux@chu-poitiers.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Medical Oncology
Principal Investigator Name
Marine Gross-Goupil
Principal Investigator Email
Marine.gross-goupil@chu-bordeaux.fr
Contact Person Name
Marine Gross-Goupil
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Heamato-oncology
Principal Investigator Name
Celine Bihan
Principal Investigator Email
Celine.bihan@ght85.fr
Contact Person Name
Celine Bihan
Contact Person Email
Celine.bihan@ght85.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Medical Oncology
Principal Investigator Name
Charlotte Joly
Principal Investigator Email
Charlotte.joly@aphp.fr
Contact Person Name
Charlotte Joly
Contact Person Email
Charlotte.joly@aphp.fr
Site Name
Clinique Victor Hugo
Department Name
Oncology – radiotherapy
Principal Investigator Name
Amandine Ruffier Loubiere
Principal Investigator Email
essaisruffier@ilcgroupe.fr
Contact Person Name
Amandine Ruffier Loubiere
Contact Person Email
essaisruffier@ilcgroupe.fr
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Oncology
Principal Investigator Name
Catherine Becht
Principal Investigator Email
becht@ccgm.fr
Contact Person Name
Catherine Becht
Contact Person Email
becht@ccgm.fr
Site Name
L'Hopital Prive Du Confluent
Department Name
Medical Oncology
Principal Investigator Name
Claude El Kouri
Principal Investigator Email
Claude.elkouri@groupeconfluent.fr
Contact Person Name
Claude El Kouri
Site Name
Assistance Publique Hopitaux De Paris (20 Rue Leblanc)
Department Name
Medical Oncology
Principal Investigator Name
Stephane Oudard
Principal Investigator Email
Stephane.oudard@aphp.fr
Contact Person Name
Stephane Oudard
Contact Person Email
Stephane.oudard@aphp.fr
Site Name
Institut Paoli Calmettes
Department Name
Medical Oncology
Principal Investigator Name
Gwenaëlle Gravis
Principal Investigator Email
gravisg@ipc.unicancer.fr
Contact Person Name
Gwenaëlle Gravis
Contact Person Email
gravisg@ipc.unicancer.fr
Site Name
Institut Bergonie
Department Name
Medical Oncology
Principal Investigator Name
Diego Teyssonneau
Principal Investigator Email
d.teyssonneau@bordeaux.unicancer.fr
Contact Person Name
Diego Teyssonneau
Site Name
Polyclinique De Blois
Department Name
Medical Oncology
Principal Investigator Name
Philippe Laplaige
Principal Investigator Email
Dr.laplaige@wanadoo.fr
Contact Person Name
Philippe Laplaige
Contact Person Email
Dr.laplaige@wanadoo.fr
Site Name
Clinique De L'Europe
Department Name
Medical Oncology
Principal Investigator Name
Faycal Hocine
Principal Investigator Email
Faycal.hocine@cthe-amiens.fr
Contact Person Name
Faycal Hocine
Contact Person Email
Faycal.hocine@cthe-amiens.fr
Site Name
Institut Godinot
Department Name
Oncology
Principal Investigator Name
Jean-Christophe Eymard
Principal Investigator Email
Jeanchristophe.eymard@reims.unicancer.fr
Contact Person Name
Jean-Christophe Eymard
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 Regional De Marseille
Department Name
Medical Oncology
Principal Investigator Name
Jean Laurent Deville
Principal Investigator Email
Jean-laurent.deville@ap-hm.fr
Contact Person Name
Jean Laurent Deville
Contact Person Email
Jean-laurent.deville@ap-hm.fr
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Oncology
Principal Investigator Name
Sophie Abadie-Lacourtoisie
Contact Person Name
Sophie Abadie-Lacourtoisie
Site Name
Institut De Cancerologie De L Ouest (Saint-Herblain)
Department Name
Medical Oncology
Principal Investigator Name
Frederic Rolland
Principal Investigator Email
Frederic.rolland@ico.unicancer.fr
Contact Person Name
Frederic Rolland
Site Name
Institut De Cancerologie De Lorraine
Department Name
Medical Oncology
Principal Investigator Name
Vincent Massard
Principal Investigator Email
v.massard@nancy.unicancer.fr
Contact Person Name
Vincent Massard
Contact Person Email
v.massard@nancy.unicancer.fr
Site Name
Centre Hospitalier Dr Jean Eric Techer
Department Name
Oncology
Principal Investigator Name
Nathalie Ibrahim
Principal Investigator Email
n.ibrahim@ch-calais.fr
Contact Person Name
Nathalie Ibrahim
Contact Person Email
n.ibrahim@ch-calais.fr
Site Name
Centre Leon Berard
Department Name
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
Site Name
Assistance Publique Hopitaux De Paris (1 Avenue Claude Vellefaux)
Department Name
Medical Oncology
Principal Investigator Name
Clement Dumont
Principal Investigator Email
Clement.dumont@aphp.fr
Contact Person Name
Clement Dumont
Contact Person Email
Clement.dumont@aphp.fr
Site Name
Centre Jean Perrin
Department Name
Oncology
Principal Investigator Name
Hakim Mahammedi
Principal Investigator Email
Hakim.mahammedi@clermont.unicancer.fr
Contact Person Name
Hakim Mahammedi
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Oncology
Principal Investigator Name
Pierre Cornillon
Principal Investigator Email
Pierre.cornillon@chu-st-etiennes.fr
Contact Person Name
Pierre Cornillon
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Medical Oncology
Principal Investigator Name
Nadine Houede
Principal Investigator Email
nadine.HOUEDE@chu-nimes.fr
Contact Person Name
Nadine Houede
Contact Person Email
nadine.HOUEDE@chu-nimes.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Medical oncology
Principal Investigator Name
Mathieu Laramas
Principal Investigator Email
MLaramas@chu-grenoble.fr
Contact Person Name
Mathieu Laramas
Contact Person Email
MLaramas@chu-grenoble.fr
Site Name
Centre Francois Baclesse
Department Name
Gynecology and Urology
Principal Investigator Name
Florence Joly
Principal Investigator Email
f.joly@baclesse.unicancer.fr
Contact Person Name
Florence Joly
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Principal Investigator Name
Yohann Loriot
Principal Investigator Email
Yohann.loriot@gustaveroussy.fr
Contact Person Name
Yohann Loriot
Contact Person Email
Yohann.loriot@gustaveroussy.fr

Germany

Earliest CTIS Part Ii Submission Date
19-08-2025
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
59
Number Of Sites
19
Number Of Participants
31

Sites

Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Universitätsklinik und Poliklinik für Urologie
Contact Person Name
Georgios Gakis
Contact Person Email
georgios.gakis@uk-halle.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Urologie und Kinderurologie
Contact Person Name
Matthias Saar
Contact Person Email
msaar@ukaachen.de
Site Name
Urologicum Dr. med. Ralf Eckert
Department Name
Urologicum Dr. med. Ralf Eckert
Contact Person Name
Ralf Eckert
Contact Person Email
R.Eckert@onlinemed.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Urologie
Contact Person Name
Arian Farid-Meck
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Urologische Klinik
Contact Person Name
Jens Bedke
Contact Person Email
j.bedke@klinikum-stuttgart.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Urologie
Contact Person Name
Christian Wuelfing
Contact Person Email
c.wuelfing@asklepios.com
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Klinik für Urologie
Contact Person Name
Florian Roghmann
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Department Name
Urologie
Principal Investigator Name
Tilman Todenhoefer
Principal Investigator Email
praxis@studienurologie.de
Contact Person Name
Tilman Todenhoefer
Contact Person Email
praxis@studienurologie.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Urologie
Principal Investigator Name
Christian Thomas
Contact Person Name
Christian Thomas
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik und Poliklinik für Urologie
Principal Investigator Name
Marc-Oliver Grimm
Principal Investigator Email
marc-oliver.grimm@med.uni-jena.de
Contact Person Name
Marc-Oliver Grimm
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Kiel)
Department Name
Klinik für Urologie und Kinderurologie
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 Ulm AöR
Department Name
Klinik für Urologie
Principal Investigator Name
Friedemann Zengerling
Principal Investigator Email
friedemann.zengerling@uniklinik-ulm.de
Contact Person Name
Friedemann Zengerling
Site Name
Staedtisches Klinikum Dresden
Department Name
4. Medizinische Klinik
Principal Investigator Name
Harald Schmalenberg
Principal Investigator Email
harald.schmalenberg@klinikum-dresden.de
Contact Person Name
Harald Schmalenberg
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
Department Name
Klinik für Urologie
Principal Investigator Name
Axel S. Merseburger
Principal Investigator Email
axel.merseburger@uksh.de
Contact Person Name
Axel S. Merseburger
Contact Person Email
axel.merseburger@uksh.de
Site Name
Heidelberg University (Mannheim)
Department Name
Klinik für Urologie und Urochirurgie
Principal Investigator Name
Frederik Wessels
Principal Investigator Email
frederik.wessels@medma.uni-heidelberg.de
Contact Person Name
Frederik Wessels
Site Name
Universitaetsklinikum Essen AöR
Department Name
Westdeutsches Tumorzentrum
Principal Investigator Name
Viktor Gruenwald
Principal Investigator Email
viktor.gruenwald@uk-essen.de
Contact Person Name
Viktor Gruenwald
Contact Person Email
viktor.gruenwald@uk-essen.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Klinik und Poliklinik für Urologie
Principal Investigator Name
Steffen Rausch
Principal Investigator Email
steffen.rausch@med.uni-tuebingen.de
Contact Person Name
Steffen Rausch
Site Name
LMU Klinikum Muenchen AöR
Department Name
Urologische Klinik und Poliklinik
Principal Investigator Name
Jozefina Casuscelli
Principal Investigator Email
jozefina.casuscelli@med.uni-muenchen.de
Contact Person Name
Jozefina Casuscelli
Site Name
Universitaetsklinikum Koeln AöR
Department Name
Klinik für Urologie
Principal Investigator Name
Axel Heidenreich
Principal Investigator Email
axel.heidenreich@uk-koeln.de
Contact Person Name
Axel Heidenreich
Contact Person Email
axel.heidenreich@uk-koeln.de

Austria

Earliest CTIS Part Ii Submission Date
23-09-2025
Latest Decision Or Authorization Date
20-10-2025
Processing Time Days
27
Number Of Sites
8
Number Of Participants
13

Sites

Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
1.Medizinische Abteilung
Principal Investigator Name
Dora Niedersüß-Beke
Contact Person Name
Dora Niedersüß-Beke
Site Name
Medical University Of Graz
Department Name
Department of Internal Medicine, Division of Oncology
Principal Investigator Name
Angelika Terbuch
Principal Investigator Email
Angelika.Terbuch@medunigraz.at
Contact Person Name
Angelika Terbuch
Contact Person Email
Angelika.Terbuch@medunigraz.at
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
IIIrd Medical Department with Hematology, Medical Oncology, Hemostaseology, Infectious Disease
Principal Investigator Name
Simon Gampenrieder
Principal Investigator Email
s.gampenrieder@salk.at
Contact Person Name
Simon Gampenrieder
Contact Person Email
s.gampenrieder@salk.at
Site Name
Universitaetsklinikum Krems
Department Name
Oncology and hematology
Principal Investigator Name
Sonia Vallet
Principal Investigator Email
Sonia.vallet@krems.lknoe.at
Contact Person Name
Sonia Vallet
Contact Person Email
Sonia.vallet@krems.lknoe.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Department of Urology
Principal Investigator Name
Renate Pichler
Principal Investigator Email
Renate.Pichler@i-med.ac.at
Contact Person Name
Renate Pichler
Contact Person Email
Renate.Pichler@i-med.ac.at
Site Name
Medical University Of Vienna
Department Name
Department of 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
Krankenhaus Der Barmherzigen Brueder Wien
Department Name
Internal Medicine II
Principal Investigator Name
Johannes Meran
Principal Investigator Email
johannes.meran@bbwien.at
Contact Person Name
Johannes Meran
Contact Person Email
johannes.meran@bbwien.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Department of Hematology, Stem Cell Therapy and Internal Oncology
Principal Investigator Name
Andreas Reichinger
Principal Investigator Email
Andreas.Reichinger@ordensklinikum.at
Contact Person Name
Andreas Reichinger

Denmark

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
5
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Rigshospitalet
Department Name
Department of Oncology
Principal Investigator Name
Helle Pappot
Principal Investigator Email
helle.pappot@regionh.dk
Contact Person Name
Helle Pappot
Contact Person Email
helle.pappot@regionh.dk
Site Name
Næstved Hospital
Department Name
Department of Oncology
Principal Investigator Name
Dorthe Yakymenko
Principal Investigator Email
doy@regionsjaelland.dk
Contact Person Name
Dorthe Yakymenko
Contact Person Email
doy@regionsjaelland.dk
Site Name
Region Midtjylland (Aarhus)
Department Name
Department of Oncology
Principal Investigator Name
Mads Agerbæk
Principal Investigator Email
mads.agerbaek@auh.rm.dk
Contact Person Name
Mads Agerbæk
Contact Person Email
mads.agerbaek@auh.rm.dk
Site Name
Aalborg University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Andreas Carus
Principal Investigator Email
andreascarus@rn.dk
Contact Person Name
Andreas Carus
Contact Person Email
andreascarus@rn.dk

Spain

Earliest CTIS Part Ii Submission Date
08-10-2025
Latest Decision Or Authorization Date
20-10-2025
Processing Time Days
12
Number Of Sites
19
Number Of Participants
28

Sites

Site Name
Hospital Universitario Virgen De Valme
Department Name
Oncology
Principal Investigator Name
Eva Fernandez Parra
Principal Investigator Email
evamfparra@yahoo.es
Contact Person Name
Eva Fernandez Parra
Contact Person Email
evamfparra@yahoo.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Principal Investigator Name
Jose Pablo Maroto Rey
Principal Investigator Email
jmaroto@santpau.cat
Contact Person Name
Jose Pablo Maroto Rey
Contact Person Email
jmaroto@santpau.cat
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Alvaro Montesa Pino
Principal Investigator Email
amontesa76@hotmail.com
Contact Person Name
Alvaro Montesa Pino
Contact Person Email
amontesa76@hotmail.com
Site Name
Hospital Universitario De Badajoz
Department Name
Oncology
Principal Investigator Name
Marta Gonzalez Cordero
Principal Investigator Email
martagcordero@gmail.com
Contact Person Name
Marta Gonzalez Cordero
Contact Person Email
martagcordero@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Jose Angel Arranz Arija
Principal Investigator Email
jarranza.oncomed@gmail.com
Contact Person Name
Jose Angel Arranz Arija
Contact Person Email
jarranza.oncomed@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Daniel Ernesto Castellano Gauna
Principal Investigator Email
cdanicas@hotmail.com
Contact Person Name
Daniel Ernesto Castellano Gauna
Contact Person Email
cdanicas@hotmail.com
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Principal Investigator Name
Alvaro Pinto Marin
Principal Investigator Email
alvaropintomarin@gmail.com
Contact Person Name
Alvaro Pinto Marin
Contact Person Email
alvaropintomarin@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
Maria Jose Mendez Vidal
Principal Investigator Email
mjosemv@yahoo.es
Contact Person Name
Maria Jose Mendez Vidal
Contact Person Email
mjosemv@yahoo.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Principal Investigator Name
Alberto Sanchez-Camacho Mejias
Principal Investigator Email
sanchezmejias@hotmail.es
Contact Person Name
Alberto Sanchez-Camacho Mejias
Contact Person Email
sanchezmejias@hotmail.es
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Oncology
Principal Investigator Name
Irene Ortiz Rubio
Principal Investigator Email
ireneortiz@iconcologia.net
Contact Person Name
Irene Ortiz Rubio
Contact Person Email
ireneortiz@iconcologia.net
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Principal Investigator Name
Regina Girones Sarrio
Principal Investigator Email
girones_reg@gva.es
Contact Person Name
Regina Girones Sarrio
Contact Person Email
girones_reg@gva.es
Site Name
Hospital Del Mar
Department Name
Oncology
Principal Investigator Name
Alejo Martin Rodriguez-Vida Rodriguez
Principal Investigator Email
arodriguezvida@parcdesalutmar.cat
Contact Person Name
Alejo Martin Rodriguez-Vida Rodriguez
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology
Principal Investigator Name
Elena Almagro Casado
Principal Investigator Email
elena.almagro@quironsalud.es
Contact Person Name
Elena Almagro Casado
Contact Person Email
elena.almagro@quironsalud.es
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Oncology
Principal Investigator Name
Nuria Sala Gonzalez
Principal Investigator Email
nsgonzalez@iconcologia.net
Contact Person Name
Nuria Sala Gonzalez
Contact Person Email
nsgonzalez@iconcologia.net
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Oscar Reig Torras
Principal Investigator Email
oreig@clinic.cat
Contact Person Name
Oscar Reig Torras
Contact Person Email
oreig@clinic.cat
Site Name
Hospital Quironsalud Barcelona
Department Name
Oncology
Principal Investigator Name
Fabricio Racca Bussano
Principal Investigator Email
fracca@nextoncology.eu
Contact Person Name
Fabricio Racca Bussano
Contact Person Email
fracca@nextoncology.eu
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Principal Investigator Name
Pablo Gajate Borau
Principal Investigator Email
pgajateborau@gmail.com
Contact Person Name
Pablo Gajate Borau
Contact Person Email
pgajateborau@gmail.com
Site Name
MD Anderson Cancer Center (Madrid)
Department Name
Oncology
Principal Investigator Name
Ana Lucrecia Ruiz Echevarria
Principal Investigator Email
alruiz@hospiten.es
Contact Person Name
Ana Lucrecia Ruiz Echevarria
Contact Person Email
alruiz@hospiten.es

Sponsor

Primary sponsor

Full Name
Daiichi Sankyo Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
IQVIA Limited
Responsibilities
Sponsor duties codes: 1, 11, 12, 13, 2, 5
Name
Syneos Health Inc.
Name
Suvoda LLC

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging, ILD adjudication committee, ePRO","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Japan","full_name":"Daiichi Sankyo Co. Ltd.","duties_or_roles":"Biomarker testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Sample management","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties codes: 1, 11, 12, 13, 2, 5","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long-term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Sample management","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Biostatistics","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Datopotamab deruxtecan
Active Substance
DATOPOTAMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Not authorised (product prodAuthStatus=1 in CTIS record)
Starting Dose
4 mg/kg
Dose Levels
4 mg/kg | 6 mg/kg
Maximum Dose
6 mg/kg (maxDailyDoseAmount 6 mg/kg as listed)
Dose Escalation Increase
4 mg/kg -> 6 mg/kg
Investigational Product Name
Ribozar (Gemcitabine)
Active Substance
GEMCITABINE
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (product prodAuthStatus=2 in CTIS record)
Starting Dose
Up to 1000 mg/m2
Dose Levels
Up to 1000 mg/m2
Maximum Dose
1000 mg/m2 (maxDailyDoseAmount as listed)
Investigational Product Name
Cisplatin Hikma
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (product prodAuthStatus=2 in CTIS record)
Starting Dose
Up to 70 mg/m2
Dose Levels
Up to 70 mg/m2
Maximum Dose
70 mg/m2 (maxDailyDoseAmount as listed)
Investigational Product Name
Carboplatin Hikma
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (product prodAuthStatus=2 in CTIS record)
Starting Dose
Up to 750 mg
Dose Levels
Up to 750 mg
Maximum Dose
750 mg (maxDailyDoseAmount as listed)
Combination Treatment
Yes

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