Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
192
Countries
2
Sites
8
Metastatic Solid Tumors
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Oct 2019 → ongoing
- Decision date (initial)
- 2023-07-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503425-18-00
- EudraCT number
- 2019-000779-18
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 24 | 2 |
| Spain | Ongoing, recruitment ended | 88 | 6 |
| Rest of world
Moldova, Republic of, Singapore, Brazil, Georgia, Mexico, Korea, Republic of, Turkey, United States, Israel, United Kingdom
|
— | 80 | — |
Investigational sites
Odense University Hospital
Odense Universitetshospital, Onkologisk Afdeling R, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Rigshospitalet; Fase 1 Enhed - Onkologi, Blegdamsvej 9, 2100, Copenhagen Oe
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Vall D Hebron Institute Of Oncology
Oncology, Calle Natzaret 115, 08035, Barcelona
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, 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 |
|---|---|---|---|---|---|
| Denmark | 2019-10-02 | 2019-11-01 | 2024-08-13 | ||
| Spain | 2019-11-05 | 2019-11-07 | 2024-08-13 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-05 | Denmark | Acceptable 2023-07-27
|
2023-07-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-26 | Denmark | Acceptable 2023-07-27
|
2024-09-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-10 | Denmark | Acceptable 2023-07-27
|
2024-10-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-17 | Denmark | Acceptable | 2024-11-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-11 | Denmark | Acceptable 2025-04-29
|
2025-04-30 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-03 | Acceptable | 2025-08-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-14 | Denmark | Acceptable 2026-01-19
|
2026-01-19 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-11 | Denmark | Acceptable 2026-01-19
|
2026-03-11 |