Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
Non-Muscle-Invasive Bladder Cancer (NMIBC) refractory
Key facts
- Sponsor
- Institut De Cancerologie De L Ouest
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-11-26
- 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
Non-Muscle-Invasive Bladder Cancer (NMIBC) refractory
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10087211 | Non-muscle invasive bladder cancer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut De Cancerologie De L Ouest
- Sponsor organisation
- Institut De Cancerologie De L Ouest
- Address
- Bd Du Professeur Jacques Monod
- City
- St Herblain
- Postcode
- 44800
- Country
- France
Scientific contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- Caroline ROUSSEAU
Public contact point
- Organisation
- Institut De Cancerologie De L Ouest
- Contact name
- Nadia ALLAM
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Nuclear Medicine, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-18 | France | Acceptable with conditions 2025-11-26
|
2025-11-26 |