Clinical trial • Phase I • Oncology|Other
GEH200520 Injection for Malignant solid tumor|Head and neck squamous cell carcinoma
Phase I trial of GEH200520 Injection for Malignant solid tumor|Head and neck squamous cell carcinoma. adaptive. 50 participants.
Overview
- Trial Therapeutic Area
- Oncology|Other
- Trial Disease
- Malignant solid tumor|Head and neck squamous cell carcinoma
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical|Diagnostic agent|Small molecule
Key dates
- Initial CTIS Submission Date
- 14-06-2024
- First CTIS Authorization Date
- 03-07-2024
Trial design
adaptive Phase I trial across 2 sites in Netherlands.
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 50
Eligibility
Recruits 50 Vulnerable population selected (isVulnerablePopulationSelected: true); no details provided in the record about consent/assent procedures or protections..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true); no details provided in the record about consent/assent procedures or protections.
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 52
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 50
Netherlands
- Earliest CTIS Part Ii Submission Date
- 24-06-2024
- Latest Decision Or Authorization Date
- 14-08-2025
- Processing Time Days
- 416
- Number Of Sites
- 2
- Number Of Participants
- 50
Sites
- Site Name
- Stichting Amsterdam UMC
- Department Name
- Medical Oncology
- Contact Person Name
- Catharina Willemien Menke-van der Houven van Oordt
- Contact Person Email
- c.menke@vumc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Medical Oncology
- Contact Person Name
- Derk Jan de Groot
- Contact Person Email
- d.j.a.de.groot@umcg.nl
Sponsor
Primary sponsor
- Full Name
- GE Healthcare Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- GEH200520 Injection
- Modality
- Diagnostic agent|Small molecule
- Routes Of Administration
- Injection
- Route
- Injection
- First In Human
- Yes
- Investigational Product Name
- GEH200521 (18F) Injection
- Modality
- Radiopharmaceutical|Diagnostic agent
- Routes Of Administration
- Injection
- Route
- Injection
- First In Human
- Yes
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