A study of YL201 and atezolizumab for patients with advanced solid tumors

1 1 1 1

What is this study about?

This study focuses on individuals with advanced solid tumors, which are types of cancer that have started in organs and have grown or spread. The research aims to evaluate the safety and effectiveness of a new drug called YL201 when it is used alongside another medication known as atezolizumab. This combination therapy is being investigated to see how well it can work against cancer cells.

During the study, participants will receive treatments through an intravenous infusion, which is a method where medicine is delivered directly into a vein. The process involves monitoring how the body handles the drugs and observing how the tumors respond to the combined treatment. This research is divided into different stages to first determine the safest dose of the medication and then to measure how much the cancer shrinks or how long it stays under control.

Who Can Join the Study?

You must be able to provide written informed consent, which means you agree to participate in the study after being fully informed about it.
You must be 18 years of age or older.
You must have an ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical strength.
You must have a confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC), which is a specific, advanced type of lung cancer that has spread.
You must not have received any prior systemic anti-cancer treatment, meaning you have not previously taken medicines designed to treat cancer throughout your entire body.
You must have at least one evaluable tumor lesion, which means there is at least one tumor that doctors can clearly see and measure using standard rules called RECIST.
You must have adequate organ and bone marrow function, meaning your vital organs (like your liver and kidneys) and your bone marrow (the part inside your bones that makes blood cells) are working properly.
You must have a life expectancy of 3 months or more.

Who Cannot Join the Study?

Having received any previous treatments that target B7H3, which is a specific protein found on certain cancer cells.
Having an uncontrolled infection, which means a germ-related illness that is not currently under medical management, and requires systemic therapy, which is medicine that travels through the entire body.
Having an active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV), which are types of liver infections.
A history of severe hypersensitivity reactions, which are extreme allergic reactions, to the medicines in this study, their inactive ingredients, or other mAbs, which are a type of medicine called monoclonal antibodies designed to target specific parts of the immune system or cancer cells.
Having previously used TOP1 inhibitors or ADCs (antibody-drug conjugates, which are medicines that combine an antibody with a drug to target cancer) that contain TOP1 inhibitors.
Having had major surgery within 4 weeks before the first dose of the study drug or needing major surgery during the study.
Having brain metastases, which are cancer cells that have spread to the brain, that are either causing symptoms or actively growing.
Having an active or previously recorded autoimmune, inflammatory, or immune deficiency disorder, which are conditions where the body’s immune system attacks its own healthy tissues or does not work properly; this includes autoimmune pneumonitis (inflammation of the lung tissue) or autoimmune myocarditis (inflammation of the heart muscle).
Having received a live vaccine within 4 weeks before the first dose of the study drug.
Having received systemic steroids or other immunosuppressive therapy, which are medicines that lower the body’s ability to fight infection, within 2 weeks before starting the study treatment.
Having clinically significant concomitant pulmonary disease, which means having lung disease that is important enough to affect your health while participating in the study.
Having uncontrolled or clinically significant cardiovascular disease, which means having heart or blood vessel problems that are either not well-managed or are serious enough to impact your health.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Comite Entreprise Paul Papin	Angers	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hospital Foch	Suresnes	France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Micancer Center S.L.P.	Barcelona	Spain
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Med Polonia Sp. z o.o.	Poznan	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Universita’ Politecnica Delle Marche	Ancona	Italy
Hospital Universitario Virgen De Valme	Sevilla	Spain
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Hospital Hm Nou Delfos	Barcelona	Spain
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
L’Hopital Prive Du Confluent	Nantes	France
Hwnennht Uckaudogsasro Dv Bwnuzqn	Badajoz	Spain
Izihtyloc Ojuibicvhy Dqx Rwgrra Syib	Barcelona	Spain
Bpdtaaerota Vdisgswzy Oegggzxhtmmz	Kecskemet	Hungary
Izkksupi Rowfoieso Ptb Ld Sqbcog Dvr Tsdqib Deew Abasnaw Ixbr Snqtbt	Meldola	Italy
Ivkmwlwr Cfjbcl Difqgrikysdhoqkne	L'hospitalet De Llobregat	Spain
Haugcsob Vrxu ddsytcxa	Barcelona	Spain
Wckfhrrkdr Szkdaie Ijt Shsmgmi Pux W Pkkebugbr	Przemysl	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	05.03.2026
France	Recruiting	05.03.2026
Germany	Not yet recruiting	05.03.2026
Hungary	Not yet recruiting	05.03.2026
Italy	Recruiting	05.03.2026
Poland	Recruiting	05.03.2026
Romania	Recruiting	05.03.2026
Spain	Recruiting	05.03.2026

Trial locations

Investigated drugs:

Tecentriq is a type of immunotherapy that helps the body’s own immune system recognize and attack cancer cells.

YL201 is an experimental drug being studied for its ability to fight advanced solid tumors, especially when used alongside other cancer treatments.

Investigated diseases:

Neoplasm malignant

Solid tumors – These are masses of abnormal cells that form in various parts of the body and do not spread through the body’s fluids. They originate from healthy tissue and grow as a collection of cells that divide uncontrollably. As the condition progresses, the tumor mass can expand and may invade nearby tissues or organs. These growths are characterized by their physical structure and localized origin.

Trial ID:

2025-523742-27-00

Protocol code:

YL201-INT-102-02

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

A study of YL201 and atezolizumab for patients with advanced solid tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?