Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
101
Countries
1
Sites
4
Patients with recurrent and/or metastatic solid cancer.
Key facts
- Sponsor
- Institut Curie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 18 May 2021 → ongoing
- Decision date (initial)
- 2024-11-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518362-27-00
- EudraCT number
- 2020-003599-42
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with recurrent and/or metastatic solid cancer.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Curie
- Sponsor organisation
- Institut Curie
- Address
- 26 Rue D Ulm
- City
- Paris
- Postcode
- 75005
- Country
- France
Scientific contact point
- Organisation
- Institut Curie
- Contact name
- Marie-Paule Sablin
Public contact point
- Organisation
- Institut Curie
- Contact name
- Marie-Paule Sablin
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 101 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Gustave Roussy
Oncologie médicale - essais précoces, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Oncologie médicale - essais précoces, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Curie
Oncologie médicale - essais précoces, 26 Rue D Ulm, 75005, Paris
Centre Francois Baclesse
Oncologie médicale - essais précoces, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
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 | 2021-05-18 | 2021-05-18 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | France | Acceptable 2024-11-08
|
2024-11-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-05 | France | Acceptable | 2025-01-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-07 | France | Acceptable 2025-11-26
|
2025-11-28 |