Clinical trial • Phase I/II • Oncology

YL201 for Advanced solid tumors

Phase I/II trial of YL201 for Advanced solid tumors. open-label, none/not specified-controlled, adaptive. 110 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced solid tumors
Trial Stage
Phase I/II
Drug Modality
Other antibody|Monoclonal antibody

Key dates

Initial CTIS Submission Date
10-11-2025
First CTIS Authorization Date
17-03-2026

Trial design

open-label, none/not specified-controlled, adaptive Phase I/II trial across 32 sites in Belgium, France, Germany and others.

Open Label
Yes
Comparator
None/Not specified
Adaptive
True, Part 1 includes a dose-escalation to determine the maximum tolerated dose (MTD); no detailed escalation rules or interim analysis/stopping rules are provided in the available record.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
110

Eligibility

Recruits 110 No vulnerable populations selected. Participants must be capable of providing written informed consent and be aged 18 years or older (no assent procedures described)..

Vulnerable Population
No vulnerable populations selected. Participants must be capable of providing written informed consent and be aged 18 years or older (no assent procedures described).

Inclusion criteria

  • {"criterion_text":"- Capable of providing written informed consent.\n- 18 years of age or older\n- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1\n- Pathologically confirmed diagnosis of ES-SCLC\n- No prior systemic anti-cancer treatment\n- Have at least 1 evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n- Adequate organ and bone marrow function\n- Life expectancy of ≥3 months"}

Exclusion criteria

  • {"criterion_text":"- Any prior targeting B7H3 treatments\n- Any prior therapy with TOP1 inhibitors or ADCs composed of TOP1 inhibitors\n- Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study\n- Symptomatic or actively progressing brain metastases\n- Active or prior documented autoimmune, inflammatory disorders, or immune deficiency, autoimmune pneumonitis, and autoimmune myocarditis\n- Received any live vaccine within 4 weeks before the first dose of study drug\n- Received systemic steroids or other immunosuppressive therapy within 2 weeks prior to initiation of study treatment\n- Clinically significant concomitant pulmonary disease\n- Uncontrolled or clinically significant cardiovascular disease\n- Uncontrolled infection that requires systemic therapy\n- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n- A history of severe hypersensitivity reactions to drug substances, inactive ingredients in the drug product, or other mAbs"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part 1 Primary Endpoints •\tAEs, laboratory abnormalities and DLTs","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Part 2 Primary Endpoints •\tORR: assessed using RECIST version 1.1 •\tPFS: assessed using RECIST version 1.1","definition_or_measurement_approach":"ORR and PFS: assessed using RECIST version 1.1 (explicitly stated)."}

Secondary endpoints

  • {"endpoint_text":"- Part 1: Secondary Endpoints •\tPK parameters •\tIncidence of anti-YL201 antibodies •\tORR: assessed using RECIST version 1.1","definition_or_measurement_approach":"PK parameters: pharmacokinetic measurements; Incidence of anti-YL201 antibodies: immunogenicity assessment; ORR: assessed using RECIST version 1.1."}
  • {"endpoint_text":"- Part 2: •\tAEs and laboratory abnormalities •\tPK parameters •\tIncidence of anti-YL201 antibodies •\tDOR: assessed using RECIST version 1.1 •\tOS","definition_or_measurement_approach":"AEs and lab abnormalities: safety reporting; PK parameters: pharmacokinetic measurements; Incidence of anti-YL201 antibodies: immunogenicity; DOR: assessed using RECIST v1.1; OS: overall survival."}

Recruitment

Digital Remote Recruitment
True, PatientGO digital app and associated data consent/privacy/EULA documents are explicitly listed (PatientGO materials associated with recruitment materials).
Planned Sample Size
110
Recruitment Window Months
19
Consent Approach
Informed consent must be provided in writing by the participant (criterion: 'Capable of providing written informed consent.'). Minimum age is 18 years. Multiple subject information and informed consent form documents are provided in several languages (document titles include EN, FR, ES, IT, DE, HU, PL, RO, NL/DUTCH), indicating language-specific ICFs are available.

Methods

  • K1/K2 recruitment arrangements documents (country-specific recruitment arrangement documents are listed for multiple countries: BE, FR, IT, ES, PL, etc.).
  • PatientGO App (digital recruitment/material) — referenced by document titles: 'K2_Recruitment Material_PatientGO App', 'K2_Recruitment Material_PatientGO Patient Info Sheet', 'K2_Recruitment Material_PatientGO Data Consent Form', 'K2_Recruitment Material_PatientGO Privacy Policy', 'K2_Recruitment Material_PatientGO EULA' (digital/remote patient engagement referenced in recruitment materials).
  • Reimbursement and payment materials — 'K2_Recruitment Material_ Reimbursement Payment Details Form', 'K2_Recruitment Material_Payment Card Letter'.
  • Standard site-based recruitment via listed hospital/clinic sites (multiple oncology centres across countries, documented via country-specific recruitment arrangement files).

Geography

Total Number Of Sites
32
Total Number Of Participants
133

Belgium

Earliest CTIS Part Ii Submission Date
10-03-2026
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
8
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Oncology
Contact Person Name
Jean-Charles Goeminne

France

Earliest CTIS Part Ii Submission Date
12-01-2026
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
67
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie Medicale
Contact Person Name
Judith RAIMBOURG
Site Name
Institut Curie
Department Name
Oncologie Medicale
Contact Person Name
Catherine DANIEL
Contact Person Email
catherine.daniel@curie.fr
Site Name
Centre Antoine Lacassagne
Department Name
Departement d‘Oncologie
Contact Person Name
Victoria FERRARI
Site Name
L'Hopital Prive Du Confluent
Department Name
Services d’oncologie medicale
Contact Person Name
Cyriac BLONZ
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

Germany

Earliest CTIS Part Ii Submission Date
17-02-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
28
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Organonkologie
Contact Person Name
Thomas Wehler

Hungary

Earliest CTIS Part Ii Submission Date
05-02-2026
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
41
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiologiai Kozpont
Contact Person Name
Zsolt Horvath
Contact Person Email
horvathzso.study@kmk.hu

Italy

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
23
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Unit of Thoracic Oncology
Contact Person Name
Angelo Delmonte
Contact Person Email
a.delmonte@irst.emr.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Clinica Oncologica
Contact Person Name
Rossana Berardi
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
U.O.C. Oncologia Medica ed Ematologia, Dipartimento di Medicina di Precisione
Contact Person Name
Carminia Maria Della Corte
Contact Person Email
roberto.alfano@unicampania.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Ospedale Santa Maria delle Croci, U.O. Oncologia, Dipartimento Onco-Ematologico
Contact Person Name
Manolo D'Arcangelo

Romania

Earliest CTIS Part Ii Submission Date
23-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
28
Number Of Sites
1
Number Of Participants
14

Sites

Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncology
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com

Spain

Earliest CTIS Part Ii Submission Date
27-11-2025
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
116
Number Of Sites
15
Number Of Participants
48

Sites

Site Name
Micancer Center S.L.P.
Department Name
Medical Oncology
Contact Person Name
Santiago Viteri Ramirez
Contact Person Email
sviteri@uomi.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Medical Oncology
Contact Person Name
Ester Garcia Lorenzo
Contact Person Email
ester.garcia@startmadrid.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Next Oncology Madrid Phase I trials
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Universitario Virgen De Valme
Department Name
Oncology
Contact Person Name
Adrian Sanchez Vegas
Contact Person Email
adrianvegas89@gmail.com
Site Name
Hospital Hm Nou Delfos
Department Name
Oncology
Contact Person Name
Tatiana Hernandez Guerrero
Site Name
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Department Name
Medical Oncology
Contact Person Name
Silvia Catot
Contact Person Email
scatot@althaia.cat
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Medical Oncology
Contact Person Name
Marta Domenech Vinolas
Contact Person Email
mdomenechv@iconcologia.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Contact Person Name
Valentina Gambardella
Contact Person Email
vgambardella@incliva.es
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Medical Oncology
Contact Person Name
Elia Sais Girona
Contact Person Email
esais@iconcologia.net
Site Name
Hospital Universitario De Torrejon
Department Name
Medical Oncology
Contact Person Name
Luis Cabezon Gutierrez
Contact Person Email
lcabezon@torrejonsalud.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Pedro Filipe Simoes da Rocha
Contact Person Email
pedrorocha@vhio.net
Site Name
Hospital Universitario De Badajoz
Department Name
Medical Oncology
Contact Person Name
Marta Gonzalez Cordero
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Contact Person Name
Maria Eugenia Olmedo Garcia
Contact Person Email
maruolmedogarcia@hotmail.com
Site Name
Instituto Oncologico Dr. Rosell S.L.
Department Name
Medical Oncology
Contact Person Name
Andres Aguilar Hernandez
Contact Person Email
aaguilar@oncorosell.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Medical Oncology
Contact Person Name
Oscar Jose Juan Vidal
Contact Person Email
juan_osc@gva.es

Poland

Earliest CTIS Part Ii Submission Date
11-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
40
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
II Klinika Chorob Pluc, Raka Pluca i Chorob Wewnetrznych
Contact Person Name
Robert Mroz
Contact Person Email
robmroz@wp.pl
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddzial Onkologiczny z Pododdzialem Dziennej Chemioterapii
Contact Person Name
Kamil Kuc
Contact Person Email
kkuc@wszp.pl
Site Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o.
Department Name
Szpital im. F. Chopina, Oddzial Onkologii Klinicznej i Chemioterapii
Contact Person Name
Cezary Szczylik
Contact Person Email
cezary.szczylik@ecz-otwock.pl
Site Name
Med Polonia Sp. z o.o.
Contact Person Name
Rodryg Ramlau

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
Active Substance
YL201
Modality
Other antibody
Routes Of Administration
IV infusion
Route
IV
Authorisation Status
Not authorised
Investigational Product Name
Tecentriq 1 200 mg concentrate for solution for infusion
Active Substance
Atezolizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation EU/1/17/1220/001)
Combination Treatment
Yes

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