Clinical trial • Oncology
sacituzumab tirumotecan for Non-muscle invasive bladder cancer (intermediate-risk)
Clinical trial of sacituzumab tirumotecan for Non-muscle invasive bladder cancer (intermediate-risk). 22 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-muscle invasive bladder cancer (intermediate-risk)
- Drug Modality
- ADC
Key dates
- Initial CTIS Submission Date
- 21-11-2024
- First CTIS Authorization Date
- 13-12-2024
Trial design
Clinical trial across 6 sites in Spain, France, Netherlands.
- Target Sample Size
- 22
Eligibility
Recruits 22 No vulnerable populations selected; consent/assent handling not specified..
- Vulnerable Population
- No vulnerable populations selected; consent/assent handling not specified.
Recruitment
- Planned Sample Size
- 22
- Recruitment Window Months
- 43
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 31
Spain
- Earliest CTIS Part Ii Submission Date
- 20-11-2024
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 425
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Urology
- Contact Person Name
- Bernardo Herrera Imbroda
- Contact Person Email
- ber.urologia@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Urology
- Contact Person Name
- Félix Guerrero Ramos
- Contact Person Email
- felixguerrero@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 28-02-2025
- Latest Decision Or Authorization Date
- 16-01-2026
- Processing Time Days
- 322
- Number Of Sites
- 3
- Number Of Participants
- 19
Sites
- Site Name
- CHU Henri Mondor
- Department Name
- Service d'Oncologie Médicale - CLIPP
- Contact Person Name
- Christophe TOURNIGAND
- Contact Person Email
- tournigand.christophe@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Urologie
- Contact Person Name
- Gautier MARCQ
- Contact Person Email
- gautier.marcq@chu-lille.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Département d'Innovation Thérapeutique et des Essais Précoces
- Contact Person Name
- Yohann LORIOT
- Contact Person Email
- Yohann.LORIOT@gustaveroussy.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 27-02-2025
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 335
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Contact Person Name
- Tahlita Zuiverloon
- Contact Person Email
- urologie.ctc@erasmusmc.nl
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- sacituzumab tirumotecan (sac-TMT)
- Active Substance
- sacituzumab tirumotecan
- Modality
- ADC
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