Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
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]
- Trial duration
- 5 Apr 2024 → ongoing
- Decision date (initial)
- 2024-03-06
- 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 | Ongoing, recruiting | 12 | 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 | 2024-04-05 | 2024-04-12 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-01 | Spain | Acceptable 2024-02-23
|
2024-03-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-04-29 | Spain | Acceptable 2024-02-23
|
2024-04-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-23 | Spain | Acceptable 2024-07-20
|
2024-07-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-14 | Spain | Acceptable 2024-10-28
|
2024-10-28 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-27 | Spain | Acceptable 2025-03-13
|
2025-03-13 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-11 | Spain | Acceptable 2025-03-13
|
2025-04-11 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-23 | Spain | Acceptable 2025-09-12
|
2025-10-06 |