Clinical trial • Phase I • Oncology

Clinical trial in Clear cell renal cell carcinoma

Phase I trial for Clear cell renal cell carcinoma. 142 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Clear cell renal cell carcinoma
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
26-08-2024
First CTIS Authorization Date
18-12-2024

Trial design

Phase I trial across 17 sites in Belgium, France, Spain.

Target Sample Size
142

Eligibility

Recruits 142 Vulnerable population selected; no details on consent or assent provided..

Vulnerable Population
Vulnerable population selected; no details on consent or assent provided.

Recruitment

Planned Sample Size
142
Recruitment Window Months
27

Geography

Total Number Of Sites
17
Total Number Of Participants
48

Belgium

Earliest CTIS Part Ii Submission Date
15-11-2024
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
311
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Principal Investigator Name
Emmanuel Seront
Principal Investigator Email
Emmanuel.seront@saintluc.uclouvain.be
Contact Person Name
Emmanuel Seront
Site Name
UZ Leuven
Department Name
Oncology
Principal Investigator Name
Benoit Beuselinck
Principal Investigator Email
Benoit.beuselinck@uzleuven.be
Contact Person Name
Benoit Beuselinck
Contact Person Email
Benoit.beuselinck@uzleuven.be
Site Name
Antwerp University Hospital
Department Name
Oncology
Principal Investigator Name
Annelies Verbiest
Principal Investigator Email
Annelies.verbiest@uza.be
Contact Person Name
Annelies Verbiest
Contact Person Email
Annelies.verbiest@uza.be
Site Name
Az Maria Middelares Gent
Department Name
Oncology
Principal Investigator Name
Christof Vulsteke
Principal Investigator Email
Christof.vulsteke@mijnziekenhuis.be
Contact Person Name
Christof Vulsteke

France

Earliest CTIS Part Ii Submission Date
19-11-2024
Latest Decision Or Authorization Date
23-09-2025
Processing Time Days
308
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Principal Investigator Name
Laurence ALBIGES
Principal Investigator Email
laurence.albiges@gustaveroussy.fr
Contact Person Name
Laurence ALBIGES
Site Name
Institut Paoli Calmettes
Department Name
Medical Oncology
Principal Investigator Name
Gwenaelle GRAVIS
Principal Investigator Email
gravisg@ipc.unicancer.fr
Contact Person Name
Gwenaelle GRAVIS
Contact Person Email
gravisg@ipc.unicancer.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
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Principal Investigator Name
Frederic ROLLAND
Principal Investigator Email
frederic.rolland@ico.unicancer.fr
Contact Person Name
Frederic ROLLAND

Spain

Earliest CTIS Part Ii Submission Date
18-11-2024
Latest Decision Or Authorization Date
24-09-2025
Processing Time Days
310
Number Of Sites
9
Number Of Participants
16

Sites

Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Oncology Service
Principal Investigator Name
Jose Luis Pérez Gracia
Principal Investigator Email
jlgracia@unav.es
Contact Person Name
Jose Luis Pérez Gracia
Contact Person Email
jlgracia@unav.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Oncology Service
Principal Investigator Name
Jose Luis Pérez Gracia
Principal Investigator Email
jlgracia@unav.es
Contact Person Name
Jose Luis Pérez Gracia
Contact Person Email
jlgracia@unav.es
Site Name
Hospital Del Mar
Department Name
Oncology Service
Principal Investigator Name
Alejo Martin Rodriguez-Vida Rodriguez
Principal Investigator Email
arodriguezvida@hospitaldelmar.cat
Contact Person Name
Alejo Martin Rodriguez-Vida Rodriguez
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology Service
Principal Investigator Name
Georgia Anguera Palacios
Principal Investigator Email
ganguera@santpau.cat
Contact Person Name
Georgia Anguera Palacios
Contact Person Email
ganguera@santpau.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology Service
Principal Investigator Name
Cristina Suarez Rodriguez
Principal Investigator Email
csuarez@vhio.net
Contact Person Name
Cristina Suarez Rodriguez
Contact Person Email
csuarez@vhio.net
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology Service
Principal Investigator Name
Enrique Gallardo Diaz
Principal Investigator Email
egallardo@tauli.cat
Contact Person Name
Enrique Gallardo Diaz
Contact Person Email
egallardo@tauli.cat
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology Service
Principal Investigator Name
Jesus Garcia-Donas Jiménez
Principal Investigator Email
jgarciadonas@hmhospitales.com
Contact Person Name
Jesus Garcia-Donas Jiménez
Contact Person Email
jgarciadonas@hmhospitales.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology Service
Principal Investigator Name
Guillermo Antonio de Velasco Oria de Rueda
Principal Investigator Email
gdvelasco.gdv@gmail.com
Contact Person Name
Guillermo Antonio de Velasco Oria de Rueda
Contact Person Email
gdvelasco.gdv@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology Service
Principal Investigator Name
Begoña Perez Valderrama
Principal Investigator Email
bpvalderrama@gmail.com
Contact Person Name
Begoña Perez Valderrama
Contact Person Email
bpvalderrama@gmail.com

Sponsor

Primary sponsor

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

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