Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
246
Countries
2
Sites
5
Advanced or metastatic solid tumors
Key facts
- Sponsor
- Xenothera
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Nov 2023 → ongoing
- Decision date (initial)
- 2023-09-11
- 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 or metastatic solid tumors
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Xenothera
- Sponsor organisation
- Xenothera
- Address
- 21 Rue La Noue Bras De Fer
- City
- Nantes
- Postcode
- 44200
- Country
- France
Scientific contact point
- Organisation
- Xenothera
- Contact name
- Medical Director
Public contact point
- Organisation
- Xenothera
- Contact name
- Medical Director
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 48 | 1 |
| France | Ongoing, recruiting | 198 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Hospital Foch
Medical Oncology, 40 Rue Worth, 92150, Suresnes
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
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 |
|---|---|---|---|---|---|
| Belgium | 2024-07-18 | 2024-07-18 | |||
| France | 2023-11-14 | 2023-11-14 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-11 | France | Acceptable with conditions 2023-09-04
|
2023-09-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-15 | France | Acceptable 2023-10-30
|
2023-11-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-13 | France | Acceptable 2025-01-15
|
2025-01-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-02 | France | Acceptable 2026-03-13
|
2026-03-16 |