Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
12
Countries
1
Sites
2
LOCALLY ADVANCED OR METASTATIC LOW TUMOR VOLUME COLORECTAL CANCER
Key facts
- Sponsor
- NovImmune S.A.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2024-01-19
- 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
LOCALLY ADVANCED OR METASTATIC LOW TUMOR VOLUME COLORECTAL CANCER
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
- Jose Saro
Public contact point
- Organisation
- NovImmune S.A.
- Contact name
- Jose Saro
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Not authorised | 12 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-29 | Spain | Acceptable 2024-01-19
|
2024-01-19 |