Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
200
Countries
2
Sites
4
Advanced Solid Tumors
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 Apr 2024 → ongoing
- Decision date (initial)
- 2024-04-02
- 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
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
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
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 68 | 2 |
| Spain | Ongoing, recruiting | 62 | 2 |
| Rest of world
United States
|
— | 70 | — |
Investigational sites
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 | 2024-04-30 | 2024-04-30 | |||
| Spain | 2024-04-11 | 2024-04-11 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-05 | Spain | Acceptable 2024-03-20
|
2024-03-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-10 | Acceptable 2024-03-20
|
2024-04-10 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-10 | Spain | Acceptable 2024-09-18
|
2024-09-18 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-02 | Spain | Acceptable 2024-09-18
|
2024-12-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-24 | Spain | Acceptable 2025-03-27
|
2025-03-27 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-20 | Spain | Acceptable 2025-07-04
|
2025-07-29 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-01 | Acceptable | 2025-09-10 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-17 | Spain | Acceptable 2026-01-19
|
2026-01-19 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-04 | Spain | Acceptable 2026-03-23
|
2026-03-23 |