Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
106
Countries
3
Sites
6
Locally Advanced or 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
- 12 Jul 2021 → 13 Jan 2026
- Decision date (initial)
- 2024-06-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506745-33-00
- EudraCT number
- 2020-005057-24
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally Advanced or 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
3 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 10 | 1 |
| France | Ended | 8 | 2 |
| Spain | Ended | 12 | 3 |
| Rest of world
Canada, United States, Korea, Republic of, Brazil
|
— | 76 | — |
Investigational sites
Rigshospitalet
Fase 1 Enhed - Onkologi, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Bergonie
Oncologie, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Leon Berard
Departement de medecine, 28 Rue Laennec, 69008, Lyon
Hospital Universitari Vall D Hebron
Servicio de Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Clinico Universitario De Valencia
Servicio de Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Hm Sanchinarro
Servicio de Oncología, 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 |
|---|---|---|---|---|---|
| Denmark | 2021-10-04 | 2022-02-02 | 2025-02-25 | ||
| France | 2021-09-17 | 2026-01-13 | 2021-11-21 | 2025-02-25 | |
| Spain | 2021-07-12 | 2025-06-19 | 2021-07-14 | 2025-02-25 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-10 | Denmark | Acceptable 2024-06-12
|
2024-06-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-20 | Denmark | Acceptable 2024-11-29
|
2024-11-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-21 | Denmark | Acceptable 2025-05-05
|
2025-05-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-27 | Acceptable 2025-12-15
|
2026-01-06 |