Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
60
Countries
1
Sites
4
XXX CANCER ELIGIBLE FOR SECOND LINE TREATMENT
Key facts
- Sponsor
- NovImmune S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Jul 2025 → ongoing
- Decision date (initial)
- 2025-06-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
XXX CANCER ELIGIBLE FOR SECOND LINE TREATMENT
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
NovImmune S.A.
- Sponsor organisation
- NovImmune S.A.
- Address
- Chemin Du Pre-Fleuri 15
- City
- Plan-Les-Ouates
- Postcode
- 1228
- Country
- Switzerland
Scientific contact point
- Organisation
- NovImmune S.A.
- Contact name
- Clinical Trial Team
Public contact point
- Organisation
- NovImmune S.A.
- Contact name
- Clinical Trial Team
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 60 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Medical Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
Medical Oncology, Pio XII Etorbidea 36, 31008, Pamplona
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 | 2025-07-03 | 2025-07-21 | 2026-01-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-28 | Spain | Acceptable 2025-06-30
|
2025-06-30 |