Clinical trial • Phase I • Oncology
trastuzumab deruxtecan for Advanced solid tumor
Phase I trial of trastuzumab deruxtecan for Advanced solid tumor. 51 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumor
- Trial Stage
- Phase I
- Drug Modality
- ADC
Key dates
- Initial CTIS Submission Date
- 10-07-2025
- First CTIS Authorization Date
- 30-10-2025
Trial design
Phase I trial across 8 sites in Spain, France.
- Target Sample Size
- 51
Eligibility
Recruits 51 Vulnerable population selected in trial record (isVulnerablePopulationSelected = true); no further details on consent, assent or special protections provided in the available record..
- Vulnerable Population
- Vulnerable population selected in trial record (isVulnerablePopulationSelected = true); no further details on consent, assent or special protections provided in the available record.
Recruitment
- Planned Sample Size
- 51
- Recruitment Window Months
- 32
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 25
Spain
- Earliest CTIS Part Ii Submission Date
- 14-10-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 20
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Cristina Saura Manich
- Contact Person Email
- csaura@vhio.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Contact Person Name
- Noelia Martinez Jañez
- Contact Person Email
- mjnoelia@hotmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Contact Person Name
- María Jesús Vidal Losada
- Contact Person Email
- mjvidal@clinic.cat
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Contact Person Name
- Manuel Ruiz Borrego
- Contact Person Email
- manuel.ruiz.borrego.sspa@juntadeandalucia.es
France
- Earliest CTIS Part Ii Submission Date
- 24-10-2025
- Latest Decision Or Authorization Date
- 30-10-2025
- Processing Time Days
- 6
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Early Phase Unit - Medical Oncology
- Contact Person Name
- Jean-David FUMET
- Contact Person Email
- jdfumet@cgfl.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Contact Person Name
- Marie ROBERT
- Contact Person Email
- marie.robert@ico.unicancer.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Service de Pathologie Mammaire
- Contact Person Name
- George EMILE
- Contact Person Email
- g.emile@baclesse.unicancer.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Oncology
- Contact Person Name
- Thibault DE LA MOTTE ROUGE
- Contact Person Email
- t.delamotterouge@rennes.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Daiichi Sankyo Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Subcutaneous Trastuzumab Deruxtecan (DS-8201)
- Active Substance
- trastuzumab deruxtecan
- Modality
- ADC
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
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