Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
64
Countries
3
Sites
17
Non-Small Cell Lung Cancer
Key facts
- Sponsor
- Inhatarget Therapeutics
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Feb 2023 → 29 Oct 2025
- Decision date (initial)
- 2022-12-06
- 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
Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10029522 | Non-small cell lung cancer stage IV | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Inhatarget Therapeutics
- Sponsor organisation
- Inhatarget Therapeutics
- Address
- Rue Antoine De Saint-Exupery 2
- City
- Charleroi
- Postcode
- 6041
- Country
- Belgium
Scientific contact point
- Organisation
- Inhatarget Therapeutics
- Contact name
- Rémi Rosière
Public contact point
- Organisation
- Inhatarget Therapeutics
- Contact name
- Frédéric De Coninck
Locations
3 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 28 | 7 |
| France | Ended | 17 | 6 |
| Spain | Ended | 19 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
CHU Helora
Oncology, Rue Ferrer 159 Boite 1, 7100, La Louviere
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Brussels
CHU Ambroise Pare
Oncology, Boulevard President Kennedy 2, 7000, Mons
Algemeen Ziekenhuis Groeninge
Pneumology, President Kennedylaan 4, 8500, Kortrijk
CHU De Liège
Pneumology, Avenue De L'hopital 1, 4000, Liege
Az Delta
Pneumology, Deltalaan 1, 8800, Roeselare
Grand Hopital De Charleroi
Pneumology, Grand'rue 3, 6000, Charleroi
Centre Francois Baclesse
Pneumology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut De Cancerologie De L Ouest
Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Hôpital Européen George Pompidou
Oncology, 20 rue Leblanc, 75015, PARIS
Hopital Ambroise Pare
Respiratory diseases and thoracic oncology, 9 Avenue Charles De Gaulle, 92100, Boulogne Billancourt
Centre Hospitalier Universitaire De Rennes
Medical oncology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Poitiers
Medical oncology, 2 Rue De La Miletrie, 86000, Poitiers
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario La Paz
Pneumology, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
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 |
|---|---|---|---|---|---|
| Belgium | 2023-02-23 | 2023-10-11 | |||
| France | 2025-03-06 | 2025-03-06 |
Application history
15 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-09-17 | Belgium | Acceptable with conditions 2022-12-02
|
2022-12-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-12-14 | Belgium | Acceptable 2023-02-02
|
2023-02-02 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-04-03 | Belgium | Acceptable 2023-02-02
|
2023-04-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-04-03 | Belgium | Acceptable 2023-04-27
|
2023-04-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-06-21 | Belgium | Acceptable 2023-08-28
|
2023-09-04 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-09-05 | Belgium | Acceptable 2023-04-27
|
2023-09-05 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-01-15 | Belgium | Acceptable 2024-03-19
|
2024-03-25 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-04-04 | Belgium | Acceptable 2024-06-11
|
2024-06-11 |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2024-06-25 | Acceptable 2024-06-11
|
2024-09-23 | |
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2024-06-27 | Acceptable 2024-06-11
|
2024-09-19 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-10-03 | Belgium | Acceptable 2024-06-11
|
2024-10-03 |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-10-10 | Belgium | Acceptable 2024-12-20
|
2024-12-20 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-02-05 | Acceptable 2024-12-20
|
2025-02-05 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-02-12 | Acceptable | 2025-03-18 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-05-06 | Belgium | Acceptable with conditions 2025-07-22
|
2025-07-23 |