Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
234
Countries
1
Sites
5
Hormone-refractory prostate cancer
Key facts
- Sponsor
- Vir Biotechnology Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Oct 2023 → ongoing
- Decision date (initial)
- 2023-09-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-503495-24-00
- WHO UTN
- U1111-1287-6968
- ClinicalTrials.gov
- NCT05997615
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Hormone-refractory prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10062904 | Hormone-refractory prostate cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vir Biotechnology Inc.
- Sponsor organisation
- Vir Biotechnology Inc.
- Address
- 1800 Owens Street Suite 900
- City
- San Francisco
- Postcode
- 94158-2388
- Country
- United States
Scientific contact point
- Organisation
- Vir Biotechnology Inc.
- Contact name
- Carlos Pantoja
Public contact point
- Organisation
- Vir Biotechnology Inc.
- Contact name
- Clinical Sciences and Operations
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 75 | 5 |
| Rest of world
Korea, Republic of, United Kingdom, United States, Australia
|
— | 159 | — |
Investigational sites
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2023-10-30 | 2024-01-29 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-10 | Spain | Acceptable 2023-09-26
|
2023-09-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-11 | Spain | Acceptable | 2024-01-31 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-07 | Spain | Acceptable | 2024-06-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-09 | Spain | Acceptable 2025-01-16
|
2025-01-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-27 | Spain | Acceptable 2025-03-05
|
2025-03-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-02 | Spain | Acceptable 2025-08-19
|
2025-08-20 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-29 | Spain | Acceptable 2026-01-14
|
2026-02-13 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-19 | Spain | Acceptable 2026-01-14
|
2026-03-19 |