Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
50
Countries
1
Sites
4
Low tumour volume (LTV) advanced, metastatic, or recurrent solid malignancies expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5, also known as CEA).
Key facts
- Sponsor
- NovImmune SA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Jul 2024 → ongoing
- Decision date (initial)
- 2024-06-11
- 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
Low tumour volume (LTV) advanced, metastatic, or recurrent solid malignancies expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5, also known as CEA).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065143 | Malignant solid tumour | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
NovImmune SA
- Sponsor organisation
- NovImmune SA
- Address
- Chemin Du Pre-Fleuri 15
- City
- Plan-Les-Ouates
- Postcode
- 1228
- Country
- Switzerland
Scientific contact point
- Organisation
- NovImmune SA
- Contact name
- Jose Saro
Public contact point
- Organisation
- NovImmune SA
- Contact name
- Jose Saro
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 50 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
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 | 2024-07-29 | 2024-09-20 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-18 | Spain | Acceptable 2024-06-11
|
2024-06-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-22 | Spain | Acceptable 2024-06-11
|
2024-07-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-24 | Spain | Acceptable 2024-06-11
|
2024-07-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-29 | Spain | Acceptable 2024-10-10
|
2024-10-10 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-11-11 | Spain | Acceptable 2024-10-10
|
2024-11-11 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-11-14 | Spain | Acceptable 2024-10-10
|
2024-11-14 |
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-21 | Spain | Acceptable 2025-04-07
|
2025-04-29 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-10-14 | Spain | Acceptable 2025-04-07
|
2025-10-14 |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-10 | Spain | Acceptable 2026-03-27
|
2026-04-16 |