Clinical trial • Phase I • Oncology
JNJ-95437446 for Non-small cell lung cancer | Colorectal cancer | Squamous cell carcinoma of head and neck
Phase I trial of JNJ-95437446 for Non-small cell lung cancer | Colorectal cancer | Squamous cell carcinoma of head and neck. None/Not specified-controlled.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Colorectal cancer | Squamous cell carcinoma of head and neck
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 16-07-2025
- First CTIS Authorization Date
- 15-10-2025
Trial design
None/Not specified-controlled Phase I trial across 4 sites in Spain.
- Comparator
- None/Not specified
- Target Sample Size
- 328
Eligibility
Recruits 328 Vulnerable population not selected (isVulnerablePopulationSelected:false); no details on consent or assent provided..
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected:false); no details on consent or assent provided.
Recruitment
- Planned Sample Size
- 328
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 328
Spain
- Earliest CTIS Part Ii Submission Date
- 17-09-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 96
- Number Of Sites
- 4
- Number Of Participants
- 52
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- START-FJD, Early Phase Clinical Trials Unit
- Contact Person Name
- Victor Moreno
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Early Drug Development Unit
- Contact Person Name
- Elena Garralda
- Contact Person Email
- egarralda@vhio.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Medical Oncology
- Contact Person Name
- Emiliano Calvo
- Contact Person Email
- emiliano.calvo@startmadrid.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Contact Person Name
- Santiago Ponce
- Contact Person Email
- santiago.ponce@oncosur.org
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- JNJ-95437446
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