Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
36
Countries
1
Sites
5
Non-small cell lung cancer (NSCLC)
Key facts
- Sponsor
- Transgene
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Mar 2023 → 23 Jun 2025
- Decision date (initial)
- 2024-07-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513093-22-00
- EudraCT number
- 2022-000841-34
- ClinicalTrials.gov
- NCT05788926
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-small cell lung cancer (NSCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Transgene
- Sponsor organisation
- Transgene
- Address
- Parc D Innovation, 400 Boulevard Gonthier D Andernach, Cs 80166 Illkirch Graffenstaden, Illkirch Graffenstaden 400 Boulevard Gonthier D Andernach Cs 80166 Illkirch Graffenstaden
- City
- Illkirch Cedex
- Postcode
- 67405
- Country
- France
Scientific contact point
- Organisation
- Transgene
- Contact name
- Transgene Medical Affairs
Public contact point
- Organisation
- Transgene
- Contact name
- Transgene Medical Affairs
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 36 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
CHU Rennes Pontchaillou Hospital
Unité d'Investigation Clinique (UIC), 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Institut Bergonie
Unité d'essais cliniques de phase précoce, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Hôpital La Timone - APHM
Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM), 264 Rue Saint-Pierre, 13005, Marseille
Institut de Cancérologie de l'Ouest - site de Saint Herblain
Unité de Développement des Thérapeutiques Précoces (UDTP), Boulevard Jacques Monod, 44805, SAINT HERBLAIN
Hôpital Européen George Pompidou
Cancérologie médicale, 20 rue Leblanc, 75015, PARIS
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 | 2023-03-27 | 2023-04-05 | 2025-05-22 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-21 | France | Acceptable 2024-07-03
|
2024-07-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-30 | France | Acceptable 2024-07-03
|
2024-07-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-08 | France | Acceptable 2024-07-03
|
2024-10-08 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-12-11 | France | Acceptable 2024-07-03
|
2024-12-11 |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-19 | France | Acceptable 2025-06-19
|
2025-06-19 |