Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
261
Countries
3
Sites
20
Advanced solid tumors
Key facts
- Sponsor
- Medilink Therapeutics (Suzhou) Co. Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Aug 2025 → ongoing
- Decision date (initial)
- 2025-07-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517589-41-00
- ClinicalTrials.gov
- NCT05434234
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medilink Therapeutics (Suzhou) Co. Ltd.
- Sponsor organisation
- Medilink Therapeutics (Suzhou) Co. Ltd.
- Address
- B3-101 Biobay 218 Xinghu Street, Suzhou Industrial Park, Jiangsu Pilot Free Trade Zone Suzhou Industrial Park Jiangsu Pilot Free Trade Zone
- City
- Suzhou
- Postcode
- 215123
- Country
- China
Scientific contact point
- Organisation
- Medilink Therapeutics (Suzhou) Co. Ltd.
- Contact name
- Medilink Therapeutics
Public contact point
- Organisation
- Medilink Therapeutics (Suzhou) Co. Ltd.
- Contact name
- Medilink Therapeutics
Locations
3 EU/EEA countries · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 28 | 8 |
| Poland | Authorised, recruiting | 17 | 1 |
| Spain | Authorised, recruiting | 70 | 11 |
| Rest of world
United States, Canada, China
|
— | 146 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Departement Oncologie Medicale – Unite Oncologie Thoracique, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Universitaire De Bordeaux
Department of Medical Oncology, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Centre Hospitalier Regional De Marseille
CEPCM-CLIPP, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Poitiers
Medical Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Institut Curie
Department of Drug Development and Innovation (D3i), 26 Rue D Ulm, 75005, Paris
Centr Georges Francois Leclerc
Medical Oncology Department, 1 Rue Professeur Marion, 21000, Dijon
Hospital Foch
Services de Pneumologie & d’Oncologie Medicale, 40 Rue Worth, 92150, Suresnes
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Oddzial Onkologii Klinicznej i Chemioterapii, Ul. Borowa 14/18, 05-400, Otwock
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Severo Ochoa
Oncology, Avenida Orellana S/n, 28911, Leganes
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 | 2025-09-10 | ||||
| Poland | 2025-09-03 | ||||
| Spain | 2025-08-04 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-19 | Spain | Acceptable 2025-07-04
|
2025-07-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-07 | Acceptable | 2025-08-28 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-17 | Spain | Acceptable 2025-12-16
|
2025-12-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-24 | Spain | Acceptable 2026-05-21
|
2026-05-22 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-28 | Acceptable 2026-05-21
|
2026-05-28 |