Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Not authorised
Participants planned
117
Countries
1
Sites
5
Prostate Cancer
Key facts
- Sponsor
- Vaccitech PLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Male Urogenital Diseases [C12]
- Decision date (initial)
- 2023-06-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Prostate Cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vaccitech PLC
- Sponsor organisation
- Vaccitech PLC
- Address
- Unit 6-10, Zeus Building, Rutherford Avenue, Harwell Oxford Zeus Building Rutherford Avenue
- City
- Didcot
- Postcode
- OX11 0DF
- Country
- United Kingdom
Scientific contact point
- Organisation
- Vaccitech PLC
- Contact name
- Dr Margaret Marshall MD
Public contact point
- Organisation
- Vaccitech PLC
- Contact name
- Dr Margaret Marshall MD
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Not authorised | 22 | 5 |
| Rest of world
United States
|
— | 95 | — |
Investigational sites
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Catalan Institute Of Oncology
Oncology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-27 | Spain | Not acceptable 2023-06-15
|
2023-06-15 |