Clinical trial • Not applicable • Immunology | Oncology

Clinical trial in Advanced solid tumour

Not applicable trial for Advanced solid tumour. 220 participants.

Overview

Trial Therapeutic Area
Immunology | Oncology
Trial Disease
Advanced solid tumour
Trial Stage
Not applicable

Key dates

Initial CTIS Submission Date
19-09-2024
First CTIS Authorization Date
27-01-2025

Trial design

Not applicable trial across 16 sites in Romania, France, Spain and others.

Target Sample Size
220

Eligibility

Recruits 220 Vulnerable population not selected; no specific consent or assent handling described..

Vulnerable Population
Vulnerable population not selected; no specific consent or assent handling described.

Recruitment

Planned Sample Size
220
Recruitment Window Months
22

Geography

Total Number Of Sites
16
Total Number Of Participants
128

Romania

Earliest CTIS Part Ii Submission Date
17-01-2025
Latest Decision Or Authorization Date
03-02-2025
Processing Time Days
17
Number Of Sites
4
Number Of Participants
32

Sites

Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncology
Principal Investigator Name
Constantin Volovăț
Principal Investigator Email
cvolovat@gmail.com
Contact Person Name
Constantin Volovăț
Contact Person Email
cvolovat@gmail.com
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Oncology
Principal Investigator Name
Laurenția Nicoleta Galeș
Principal Investigator Email
laurentia.gales.ext@arensia-em.com
Contact Person Name
Laurenția Nicoleta Galeș
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
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncology
Principal Investigator Name
Tudor Eliade Ciuleanu
Principal Investigator Email
tudor.ciuleanu.ext@arensia-em.com
Contact Person Name
Tudor Eliade Ciuleanu

France

Earliest CTIS Part Ii Submission Date
13-01-2025
Latest Decision Or Authorization Date
29-01-2025
Processing Time Days
16
Number Of Sites
4
Number Of Participants
32

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Principal Investigator Name
Frédéric ROLLAND
Principal Investigator Email
frederic.rolland@ico.unicancer.fr
Contact Person Name
Frédéric ROLLAND
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
Institut Gustave Roussy
Department Name
Early Drug Development and Genitourinary Oncology Group
Principal Investigator Name
Yohann LORIOT
Principal Investigator Email
yohann.loriot@gustaveroussy.fr
Contact Person Name
Yohann LORIOT
Contact Person Email
yohann.loriot@gustaveroussy.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Principal Investigator Name
Diego TOSI
Principal Investigator Email
Diego.Tosi@icm.unicancer.fr
Contact Person Name
Diego TOSI
Contact Person Email
Diego.Tosi@icm.unicancer.fr

Spain

Earliest CTIS Part Ii Submission Date
16-01-2025
Latest Decision Or Authorization Date
27-01-2025
Processing Time Days
11
Number Of Sites
4
Number Of Participants
32

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Maria Julia Lostes Bardaji
Principal Investigator Email
jlostes@vhio.net
Contact Person Name
Maria Julia Lostes Bardaji
Contact Person Email
jlostes@vhio.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Principal Investigator Name
Bernard Doger de Speville
Principal Investigator Email
Bernard.doger@startmadrid.com
Contact Person Name
Bernard Doger de Speville
Contact Person Email
Bernard.doger@startmadrid.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Principal Investigator Name
Guillermo Suay Montagud
Principal Investigator Email
guillermo_suay@iislafe.es
Contact Person Name
Guillermo Suay Montagud
Contact Person Email
guillermo_suay@iislafe.es
Site Name
Hospital Quironsalud Barcelona
Department Name
Oncology
Principal Investigator Name
Omar Saavedra
Principal Investigator Email
osaavedra@nextoncology.eu
Contact Person Name
Omar Saavedra
Contact Person Email
osaavedra@nextoncology.eu

Italy

Earliest CTIS Part Ii Submission Date
15-01-2025
Latest Decision Or Authorization Date
29-01-2025
Processing Time Days
14
Number Of Sites
4
Number Of Participants
32

Sites

Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncology
Principal Investigator Name
Giuseppe Curigliano
Principal Investigator Email
giuseppe.curigliano@ieo.it
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it
Site Name
Careggi University Hospital
Department Name
Oncology
Principal Investigator Name
Lorenzo Antonuzzo
Principal Investigator Email
antonuzzol@aou-careggi.toscana.it
Contact Person Name
Lorenzo Antonuzzo
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Oncology
Principal Investigator Name
Andrea Zivi
Principal Investigator Email
andrea.zivi@aovr.veneto.it
Contact Person Name
Andrea Zivi
Contact Person Email
andrea.zivi@aovr.veneto.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncology
Principal Investigator Name
Gennaro Daniele
Principal Investigator Email
gennaro.daniele@policlinogemelli.it
Contact Person Name
Gennaro Daniele

Sponsor

Primary sponsor

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

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