Clinical trial • Phase I • Oncology

CDR404 for Solid tumor

Phase I trial of CDR404 for Solid tumor. 42 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Solid tumor
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
24-01-2024
First CTIS Authorization Date
28-04-2024

Trial design

Phase I trial across 14 sites in Denmark, Belgium, Italy and others.

Biomarker Stratified
True, HLA-A*02:01 and MAGE-A4 expression
Target Sample Size
42

Recruitment

Planned Sample Size
58
Recruitment Window Months
40

Geography

Total Number Of Sites
14
Total Number Of Participants
58

Denmark

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
763
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Rigshospitalet
Department Name
Oncology
Contact Person Name
Kristoffer Staal Rohrberg

Belgium

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
674
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Antwerp University Hospital
Department Name
Oncology
Contact Person Name
Hans Prenen
Contact Person Email
hans.prenen@uza.be
Site Name
Institut Jules Bordet
Department Name
Oncology
Contact Person Name
Nuria Kotecki
Contact Person Email
nuria.kotecki@hubruxelles.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Contact Person Name
Jean-Pascal H Machiels
Site Name
Universitair Ziekenhuis Gent
Department Name
Oncology
Contact Person Name
Sylvie W Rottey
Contact Person Email
sylvie.rottey@ugent.be

Italy

Earliest CTIS Part Ii Submission Date
25-06-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
672
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncology
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Oncology
Contact Person Name
Matteo Simonelli
Contact Person Email
matteo.simonelli@hunimed.eu

Spain

Earliest CTIS Part Ii Submission Date
05-06-2024
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
688
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Department Name
Oncology
Contact Person Name
Desamparados Roda Perez
Contact Person Email
derope@hotmail.com
Site Name
Vall D'hebron Institut De Recerca
Department Name
Oncology
Contact Person Name
Alberto Hernando Calvo
Contact Person Email
albertohernando@vhio.net
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Guillermo Suay Montagud
Contact Person Email
guillermo_suay@iislafe.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Guillermo de Velasco
Contact Person Email
gdvelasco.gdv@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Ramon Salazar Soler
Contact Person Email
ramonsalazar@iconcologia.net
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Emiliano Calvo Aller
Contact Person Email
emiliano.calvo@startmadrid.com
Site Name
Hospital Universitario Y Politecnico La Fe (additional site entry)
Department Name
Oncology

Sponsor

Primary sponsor

Full Name
CDR-Life AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
CDR404
First In Human
Yes

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