Clinical trial • Phase I • Oncology

YL201 for Advanced solid tumors

Phase I trial of YL201 for Advanced solid tumors. 146 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced solid tumors
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
19-03-2025
First CTIS Authorization Date
07-07-2025

Trial design

Phase I trial across 21 sites in France, Spain, Poland.

Target Sample Size
146

Eligibility

Recruits 146 No vulnerable populations selected (isVulnerablePopulationSelected: false)..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false).

Recruitment

Planned Sample Size
146
Recruitment Window Months
35

Geography

Total Number Of Sites
21
Total Number Of Participants
115

France

Earliest CTIS Part Ii Submission Date
02-06-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
203
Number Of Sites
8
Number Of Participants
28

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Department of Medical Oncology
Contact Person Name
Amaury DASTE
Contact Person Email
amaury.daste@chu-bordeaux.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Contact Person Name
Sandrine HIRET
Site Name
Hospital Foch
Department Name
Services de Pneumologie & d’Oncologie Medicale
Contact Person Name
Alexandra BIZOT
Contact Person Email
a.bizot@hopital-foch.com
Site Name
Centr Georges Francois Leclerc
Department Name
Medical Oncology Department
Contact Person Name
Francois GHIRINGHELLI
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
CEPCM-CLIPP
Contact Person Name
Laurent GREILLIER
Contact Person Email
laurent.greillier@ap-hm.fr
Site Name
Institut Curie
Department Name
Department of Drug Development and Innovation (D3i)
Contact Person Name
Marie-Paule SABLIN
Contact Person Email
mariepaule.sablin@curie.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Medical Oncology
Contact Person Name
Nicolas ISAMBERT
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Departement Oncologie Medicale – Unite Oncologie Thoracique
Contact Person Name
Jeanne CHEN
Contact Person Email
jeanne.chen@chu-nantes.fr

Spain

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
175
Number Of Sites
11
Number Of Participants
70

Sites

Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Bernard Doger de Speville
Contact Person Email
bernard.doger@startmadrid.com
Site Name
Hospital Universitario Severo Ochoa
Department Name
Oncology
Contact Person Name
Ana Lopez Martin
Contact Person Email
almartin@salud.madrid.org
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Juan Jose Soto Castillo
Contact Person Email
juanj.soto@startmadrid.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Georgia Anguera Palacios
Contact Person Email
ganguera@santpau.cat
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Andres Cervantes Ruiperez
Contact Person Email
andres.cervantes@uv.es
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Anna Vilalta-Lacarra
Contact Person Email
avilaltal@unav.es
Site Name
Hospital Quironsalud Barcelona
Department Name
Oncology
Contact Person Name
Fabricio Racca
Contact Person Email
fracca@nextoncology.eu
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Jon Zugazagoitia Fraile
Contact Person Email
j.zugazagoitia.imas12@h12o.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Federico Longo
Contact Person Email
fedelongomunoz@hotmail.com
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Oncology
Contact Person Name
Anna Vilalta-Lacarra
Contact Person Email
avilaltal@unav.es

Poland

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
179
Number Of Sites
2
Number Of Participants
17

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddzial Chemioterapii
Contact Person Name
Rodryg Ramlau
Contact Person Email
katedraonkologii@ump.edu.pl
Site Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Department Name
Oddzial Onkologii Klinicznej i Chemioterapii
Contact Person Name
Cezary Szczylik
Contact Person Email
cezary.szczylik@ecz-otwock.pl

Sponsor

Primary sponsor

Full Name
Medilink Therapeutics (Suzhou) Co. Ltd.
Organisation Type
Pharmaceutical company
Country Of Registered Address
China

Investigational products

Investigational Product Name
YL201

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