Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
84
Countries
2
Sites
4
Participants with advanced ( unresectable, recurrent or metastatic) solid tumours
Key facts
- Sponsor
- Domain Therapeutics
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Nov 2022 → 8 Apr 2025
- Decision date (initial)
- 2024-09-06
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516206-28-00
- EudraCT number
- 2022-000092-40
- ClinicalTrials.gov
- NCT05582850
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Participants with advanced ( unresectable, recurrent or metastatic) solid tumours
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Domain Therapeutics
- Sponsor organisation
- Domain Therapeutics
- Address
- 220 Boulevard Gonthier D Andernach
- City
- Illkirch-Graffenstaden
- Postcode
- 67400
- Country
- France
Scientific contact point
- Organisation
- Domain Therapeutics
- Contact name
- Clinical Development
Public contact point
- Organisation
- Domain Therapeutics
- Contact name
- Clinical Development
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 40 | 2 |
| France | Ended | 44 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Oncopole Claudius Regaud
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Curie
Unité d’investigation clinique – D3I, 26 Rue D Ulm, 75005, Paris
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 | 2022-11-17 | 2025-04-08 | 2022-11-24 | 2025-01-14 | |
| France | 2022-12-22 | 2025-04-08 | 2023-01-17 | 2025-01-14 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-29 | France | Acceptable 2024-09-05
|
2024-09-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-24 | France | Acceptable 2024-09-05
|
2024-09-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-15 | France | Acceptable 2024-09-05
|
2024-10-15 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-10-31 | France | Acceptable 2024-09-05
|
2024-10-31 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-12-09 | France | Acceptable 2024-09-05
|
2024-12-09 |