Clinical trial • Phase I • Oncology|Infectious Disease|Other
FluBHPVE6E7 immunotherapy for Human papillomavirus infection|HPV16-associated oropharyngeal squamous cell carcinoma
Phase I trial of FluBHPVE6E7 immunotherapy for Human papillomavirus infection|HPV16-associated oropharyngeal squamous cell carcinoma. 12 participants.
Overview
- Trial Therapeutic Area
- Oncology|Infectious Disease|Other
- Trial Disease
- Human papillomavirus infection|HPV16-associated oropharyngeal squamous cell carcinoma
- Trial Stage
- Phase I
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 12-07-2024
- First CTIS Authorization Date
- 12-08-2024
Trial design
Phase I trial across 2 sites in Austria.
- Target Sample Size
- 12
- Trial Duration For Participant
- 1889
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 62
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 12
Austria
- Earliest CTIS Part Ii Submission Date
- 22-07-2024
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 647
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Clinical Pharmacology
- Principal Investigator Name
- Michael Wolzt
- Principal Investigator Email
- michael.wolzt@meduniwien.ac.at
- Contact Person Name
- Michael Wolzt
- Contact Person Email
- michael.wolzt@meduniwien.ac.at
- Site Name
- Krankenhaus Der Barmherzigen Schwestern Wien Betriebsgesellschaft mbH
- Department Name
- Department of Ear, Nose and Throat Diseases
- Principal Investigator Name
- Andreas Strobl
- Principal Investigator Email
- andreas.strobl@ordensklinikum.at
- Contact Person Name
- Andreas Strobl
- Contact Person Email
- andreas.strobl@ordensklinikum.at
Sponsor
Primary sponsor
- Full Name
- Bluesky Immunotherapies GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Austria
Investigational products
- Investigational Product Name
- FluBHPVE6E7 immunotherapy
- Modality
- Vaccine
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