Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
126
Countries
2
Sites
4
Advanced solid tumors
Key facts
- Sponsor
- Johnson And Johnson Enterprise Innovation Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Jun 2024 → ongoing
- Decision date (initial)
- 2024-03-28
- 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 solid tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Johnson And Johnson Enterprise Innovation Inc.
- Sponsor organisation
- Johnson And Johnson Enterprise Innovation Inc.
- Address
- 1 Johnson And Johnson Plaza
- City
- New Brunswick
- Postcode
- 08933-0001
- Country
- United States
Scientific contact point
- Organisation
- Johnson And Johnson Enterprise Innovation Inc.
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Johnson And Johnson Enterprise Innovation Inc.
- 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 | 25 | 1 |
| Spain | Ongoing, recruiting | 25 | 3 |
| Rest of world
Canada, United States
|
— | 76 | — |
Investigational sites
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, 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 |
|---|---|---|---|---|---|
| France | 2024-11-05 | 2024-11-05 | |||
| Spain | 2024-06-18 | 2024-08-29 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-24 | Spain | Acceptable with conditions 2024-03-25
|
2024-03-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-17 | Spain | Acceptable 2024-06-18
|
2024-06-18 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-06-24 | Spain | Acceptable 2024-06-18
|
2024-06-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-28 | Acceptable | 2024-07-11 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-13 | Spain | Acceptable 2025-03-27
|
2025-03-27 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-07 | Spain | Not acceptable 2025-09-29
|
2025-09-30 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-08 | Spain | Acceptable 2026-02-18
|
2026-02-24 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-04-01 | Spain | Acceptable 2026-05-18
|
2026-05-26 |