Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
645
Countries
3
Sites
10
Participants with Locally Advanced or Metastatic HER2-Expressing Cancers
Key facts
- Sponsor
- Vir Biotechnology Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Apr 2022 → ongoing
- Decision date (initial)
- 2024-09-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516010-38-00
- EudraCT number
- 2021-004731-91
- ClinicalTrials.gov
- NCT05356741
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Participants with Locally Advanced or Metastatic HER2-Expressing Cancers
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
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 50 | 3 |
| Portugal | Ongoing, recruiting | 40 | 1 |
| Spain | Ongoing, recruiting | 150 | 6 |
| Rest of world
Australia
|
— | 405 | — |
Investigational sites
Oncopole Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Gustave Roussy
Département d'Innovation Thérapeutique et des Essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Serviço de Oncologia Médica, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Hospital Quironsalud Barcelona
Unidad de Ensayos Fase I, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Quironsalud Madrid
NEXT Oncology Madrid, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Hm Sanchinarro
Unidad Fases I Star, Calle Ona 10, 28050, Madrid
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 |
|---|---|---|---|---|---|
| France | 2022-07-25 | 2022-11-07 | |||
| Portugal | 2022-12-29 | 2023-02-16 | |||
| Spain | 2022-04-25 | 2022-05-29 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-23 | Spain | Acceptable with conditions 2024-08-27
|
2024-08-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-22 | Spain | Acceptable with conditions | 2024-11-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-23 | Acceptable with conditions | 2024-11-07 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-10-23 | Acceptable with conditions | 2025-01-23 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-02-10 | Spain | Acceptable 2025-02-26
|
2025-02-26 |
| 6 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-05-19 | Spain | Acceptable 2025-08-19
|
2025-08-19 |
| 7 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-11-05 | Spain | Acceptable 2026-02-06
|
2026-02-06 |
| 8 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-03-06 | Spain | Acceptable 2026-05-25
|
2026-05-26 |