Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
70
Countries
1
Sites
2
Patients with advanced solid tumors.
Key facts
- Sponsor
- Innoup Farma S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Sep 2022 → ongoing
- Decision date (initial)
- 2024-09-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518126-32-00
- EudraCT number
- 2018-003026-84
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Patients with advanced solid tumors.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Innoup Farma S.L.
- Sponsor organisation
- Innoup Farma S.L.
- Address
- Plaza Cein 5, Noain C Noain C
- City
- Noain (Valle De Elorz)
- Postcode
- 31110
- Country
- Spain
Scientific contact point
- Organisation
- Innoup Farma S.L.
- Contact name
- Maite Agüeros
Public contact point
- Organisation
- Innoup Farma S.L.
- Contact name
- Maite Agüeros
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 70 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Spain | 2022-09-15 | 2022-11-11 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-16 | Spain | Acceptable with conditions 2024-09-25
|
2024-09-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-18 | Spain | Acceptable 2025-12-19
|
2026-02-09 |