Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
44
Countries
1
Sites
1
Advanced solid tumours and metastatic cancers
Key facts
- Sponsor
- iOnctura SA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-12-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518404-44-00
- EudraCT number
- 2019-000686-20
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumours and metastatic cancers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065143 | Malignant solid tumour | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
iOnctura SA
- Sponsor organisation
- iOnctura SA
- Address
- Avenue De Secheron 15
- City
- Geneva
- Postcode
- 1202
- Country
- Switzerland
Scientific contact point
- Organisation
- iOnctura SA
- Contact name
- Information
Public contact point
- Organisation
- iOnctura SA
- Contact name
- Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 34 | 1 |
| Rest of world
United Kingdom
|
— | 10 | — |
Investigational sites
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-07 | Italy | Acceptable 2024-11-04
|
2024-12-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-04 | Italy | Acceptable 2024-11-04
|
2025-08-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-21 | Italy | Acceptable 2026-02-13
|
2026-02-13 |