Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
97
Countries
4
Sites
10
Advanced and/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
- 27 Aug 2024 → ongoing
- Decision date (initial)
- 2024-07-24
- 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
Advanced and/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
4 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 12 | 1 |
| Denmark | Ongoing, recruitment ended | 13 | 1 |
| France | Ended | 12 | 4 |
| Spain | Ended | 24 | 4 |
| Rest of world
Australia, Canada, United States
|
— | 36 | — |
Investigational sites
Rigshospitalet
Fase 1 Enhed - Onkologi, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Gustave Roussy
Early Phase Trials Unit, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Oncopole Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 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 |
|---|---|---|---|---|---|
| Belgium | 2024-09-12 | 2024-09-19 | 2025-10-23 | ||
| Denmark | 2024-08-27 | 2024-08-30 | 2025-10-23 | ||
| France | 2025-06-19 | ||||
| Spain | 2024-11-19 | 2024-11-29 | 2025-10-23 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-11 | Denmark | Acceptable with conditions 2024-07-24
|
2024-07-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-07 | Denmark | Acceptable 2024-09-03
|
2024-09-03 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-09-11 | 2024-12-09 | ||
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-09-11 | Acceptable 2024-09-03
|
2024-10-28 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-26 | Denmark | Acceptable 2025-04-10
|
2025-04-11 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-07 | Denmark | Acceptable 2025-04-10
|
2025-08-07 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-07 | Denmark | Acceptable 2025-04-10
|
2025-11-07 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-17 | Denmark | Acceptable 2025-04-10
|
2025-11-17 |
| 9 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-12 | Denmark | Acceptable 2026-02-11
|
2026-02-13 |
| 10 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-18 | Denmark | Acceptable | 2026-03-10 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-05-04 | Denmark | Acceptable | 2026-05-04 |