Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
345
Countries
6
Sites
13
Advanced Solid Tumors Harboring RAS Mutation(S)
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 Feb 2026 → ongoing
- Decision date (initial)
- 2025-09-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors Harboring RAS Mutation(S)
| 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
6 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 10 | 2 |
| Denmark | Ongoing, recruiting | 10 | 1 |
| France | Authorised, recruitment pending | 10 | 2 |
| Germany | Authorised, recruitment pending | 10 | 3 |
| Netherlands | Authorised, recruitment pending | 10 | 2 |
| Spain | Ongoing, recruiting | 20 | 3 |
| Rest of world
Singapore, United States, New Zealand, United Kingdom, Canada, Taiwan, China, Hong Kong, Korea, Republic of, Australia
|
— | 275 | — |
Investigational sites
Institut Jules Bordet
N/A, Mijlenmeersstraat 90, 1070, Anderlecht
Universitair Ziekenhuis Antwerpen
N/A, Drie Eikenstraat 655, 2650, Edegem
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Oncopole Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Technische Universitaet Dresden
Medizinische Klinik I Studiensekretariat Internistische Onkologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Essen AöR
Innere Klinik (Tumorforschung), Hufelandstrasse 55, Holsterhausen, Essen
Asklepios Kliniken Hamburg GmbH
Asklepios Klinik Altona, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
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 | 2026-02-27 | 2026-03-25 | |||
| Spain | 2026-03-09 | 2026-04-29 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-20 | Denmark | Acceptable with conditions 2025-09-22
|
2025-09-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-10 | Denmark | Acceptable with conditions 2025-09-22
|
2025-12-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-14 | Denmark | Acceptable with conditions | 2026-02-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-15 | Acceptable with conditions | 2026-02-13 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-15 | Acceptable with conditions | 2026-03-02 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-15 | Acceptable with conditions | 2026-02-17 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-01-15 | Acceptable with conditions | 2026-02-23 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-16 | Acceptable with conditions | 2026-02-12 |