Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
380
Countries
1
Sites
4
Locally advanced, metastatic NSCLC, CRC, or HNSCC that has recurred or progressed after prior stand of care therapy
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
- 3 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-15
- 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, metastatic NSCLC, CRC, or HNSCC that has recurred or progressed after prior stand of care therapy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 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 · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 52 | 4 |
| Rest of world
United States, Korea, Republic of
|
— | 328 | — |
Investigational sites
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Early Drug Development Unit, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
START-FJD, Early Phase Clinical Trials Unit, Avenida De Los Reyes Catolicos 2, 28040, 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 |
|---|---|---|---|---|---|
| Spain | 2025-11-03 | 2025-11-03 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-16 | Spain | Acceptable 2025-10-13
|
2025-10-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-07 | Spain | Acceptable 2025-10-13
|
2025-11-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-04 | Spain | Acceptable | 2025-12-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-07 | Spain | Acceptable 2026-02-16
|
2026-02-17 |