Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
154
Countries
3
Sites
17
Hepatocellular Carcinoma
Key facts
- Sponsor
- Captor Therapeutics S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Apr 2025 → ongoing
- Decision date (initial)
- 2024-12-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Hepatocellular Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073071 | Hepatocellular carcinoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Captor Therapeutics S.A.
- Sponsor organisation
- Captor Therapeutics S.A.
- Address
- Ul. Dunska 11
- City
- Wroclaw
- Postcode
- 54-427
- Country
- Poland
Scientific contact point
- Organisation
- Captor Therapeutics S.A.
- Contact name
- Captor Global Regulatory Group
Public contact point
- Organisation
- Captor Therapeutics S.A.
- Contact name
- Captor Global Regulatory Group
Locations
3 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 81 | 8 |
| Germany | Authorised, recruitment pending | 17 | 3 |
| Spain | Ongoing, recruiting | 56 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Assistance Publique Hopitaux De Paris
Hepatology, 125 Rue De Stalingrad, 93000, Bobigny
Centre Hospitalier Universitaire De Nantes
Hepato-gastroenterology, 1 Place Alexis Ricordeau, 44000, Nantes
Oncopole Claudius Regaud
Medical Digestive Oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Les Hopitaux Universitaires De Strasbourg
Hepato-gastroenterology and endoscopy, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Poitiers
Medical Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Institut Gustave Roussy
Early Drug Development Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
I. Medical Department, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Heidelberg AöR
Medical Oncology, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Universitaetsklinikum Leipzig AöR
Medicine II, Hepatology, Haus 6, Liebigstrasse 20a, Leipzig
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital General Universitario De Valencia
Medical Oncology, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Universitario Miguel Servet
Medical Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario La Paz
Medical Oncology, Paseo De La Castellana 261, 28046, 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 |
|---|---|---|---|---|---|
| France | 2025-07-08 | 2025-07-08 | |||
| Spain | 2025-04-30 | 2025-05-06 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-22 | Spain | Acceptable with conditions 2024-12-16
|
2024-12-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-07 | Spain | Acceptable 2025-03-13
|
2025-03-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-30 | Spain | Acceptable 2025-03-13
|
2025-04-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-05 | Spain | Acceptable 2025-03-13
|
2025-08-05 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-23 | Spain | Acceptable 2026-01-14
|
2026-01-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-30 | Acceptable 2026-05-26
|
2026-05-28 |