Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
78
Countries
1
Sites
1
Patients with advanced solid tumour
Key facts
- Sponsor
- OSE Immunotherapeutics
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 May 2019 → 30 Apr 2025
- Decision date (initial)
- 2024-12-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519150-37-00
- EudraCT number
- 2018-003830-34
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with advanced solid tumour
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
OSE Immunotherapeutics
- Sponsor organisation
- OSE Immunotherapeutics
- Address
- 22 Boulevard Benoni Goullin
- City
- Nantes
- Postcode
- 44200
- Country
- France
Scientific contact point
- Organisation
- OSE Immunotherapeutics
- Contact name
- Lucie Begert
Public contact point
- Organisation
- OSE Immunotherapeutics
- Contact name
- Lucie Begert
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 78 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De La Reunion
Oncologie Sud, Allee Des Topazes, Cs 11021, Saint-Denis
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 | 2019-05-21 | 2025-04-30 | 2019-05-21 | 2022-05-20 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-08 | France | Acceptable 2024-12-09
|
2024-12-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-30 | France | Acceptable 2024-12-09
|
2025-01-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-24 | France | Acceptable 2024-12-09
|
2025-02-24 |