Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
106
Countries
3
Sites
9
Advanced, metastatic, or recurrent solid mesothelin-expressing malignancies
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
- 4 Apr 2022 → ongoing
- Decision date (initial)
- 2024-11-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-517752-35-00
- EudraCT number
- 2021-003808-40
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced, metastatic, or recurrent solid mesothelin-expressing malignancies
| 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 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
3 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 66 | 4 |
| Italy | Ongoing, recruiting | 25 | 3 |
| Spain | Ongoing, recruiting | 15 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Gustave Roussy
Drug Development Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Curie
Site de Recherche Intégrée sur le Cancer, 26 Rue D Ulm, 75005, Paris
Centre De Lutte Contre Le Cancer Eugene Marquis
Service d'oncologie médicale, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Assistance Publique Hopitaux De Paris
Centre d'Essais Précoces en Cancérologie (CEPEC). Centre Expert Cancer du Sein, 20 Rue Leblanc, 75015, Paris
Centro Ricerche Cliniche Di Verona S.r.l.
Oncologia Medica, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Humanitas Mirasole S.p.A.
Oncologia Medica, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Europeo Di Oncologia S.r.l.
Dipartimento di Oncologia ed Emato-Oncologia, Via Giuseppe Ripamonti 435, 20141, Milan
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 |
|---|---|---|---|---|---|
| France | 2022-04-04 | 2022-05-31 | |||
| Italy | 2022-10-17 | 2023-02-21 | |||
| Spain | 2025-09-26 | 2025-11-18 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | France | Acceptable 2024-11-05
|
2024-11-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-13 | France | Acceptable 2025-02-21
|
2025-02-26 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-03-17 | Acceptable 2025-02-21
|
2025-05-23 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-04 | France | Acceptable 2025-02-21
|
2025-06-04 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-16 | France | Acceptable 2025-08-14
|
2025-08-14 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-27 | France | Acceptable 2025-08-14
|
2025-11-27 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-19 | France | Acceptable 2025-08-14
|
2025-12-19 |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-02 | France | Acceptable 2026-04-30
|
2026-04-30 |