Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
5
Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-02
- 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
Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | PT | 10060121 | Squamous cell carcinoma of head and neck | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 8 | 5 |
| Rest of world
Japan, United States
|
— | 22 | — |
Investigational sites
Institut Gustave Roussy
Radiotherapy, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Henri Becquerel
Radiotherapy, Rue D Amiens, 76038, Rouen Cedex
Centre Hospitalier Regional Et Universitaire De Brest
Radiotherapy, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier Regional De Marseille
Centre d’Essais Précoces en Cancérologie de Marseille, 264 Rue Saint Pierre, 13005, Marseille
Centre Oscar Lambret
Radiotherapy, 3 Rue Frederic Combemale, 59000, Lille
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 | 2026-02-11 | 2026-04-13 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-15 | France | Acceptable 2025-12-19
|
2026-02-02 |