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
- Contact Person Email
- kristoffer.staal.rohrberg@regionh.dk
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
- Contact Person Email
- jean-pascal.machiels@saintluc.uclouvain.be
- 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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