Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
Patients with polymetastatic solid cancers.
Key facts
- Sponsor
- Commissariat a l'Energie Atomique et aux Energies Alternatives
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517640-57-01
- EudraCT number
- 2020-005867-30
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with polymetastatic solid cancers.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Commissariat a l'Energie Atomique et aux Energies Alternatives
- Sponsor organisation
- Commissariat a l'Energie Atomique et aux Energies Alternatives
- Address
- 4 Place Du General Leclerc
- City
- Orsay Cedex
- Postcode
- 91401
- Country
- France
Scientific contact point
- Organisation
- Commissariat a l'Energie Atomique et aux Energies Alternatives
- Contact name
- Charles TRUILLET
Public contact point
- Organisation
- Commissariat a l'Energie Atomique et aux Energies Alternatives
- Contact name
- Charles TRUILLET
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Commissariat a l'Energie Atomique et aux Energies Alternatives
Service Hospitalier Frederic Joliot, 4 Place Du General Leclerc, 91401, Orsay Cedex
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 | 2025-01-24 | 2025-01-24 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-09 | France | Acceptable 2025-01-24
|
2025-01-24 |