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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>part 1</b>: safety and dose determination

    The first phase focuses on monitoring how the body reacts to the combination therapy to ensure it is safe.

    The combination therapy consists of two medications: yl201 and atezolizumab (sold as tecentriq).

    atezolizumab is administered through an intravenous infusion, which means it is delivered directly into a vein.

    The goal of this stage is to identify the maximum tolerated dose, which is the highest amount of the medication that can be given without causing unacceptable side effects.

  2. Step 2

    <b>part 2</b>: effectiveness assessment

    After the safety of the doses is established, the second phase evaluates how well the combination therapy works against the solid tumors.

    The combination therapy continues to use yl201 and atezolizumab via intravenous infusion.

    The effectiveness is measured by looking at the objective response rate, which tracks whether the tumor shrinks, and the progression-free survival, which tracks how long the disease remains stable without getting worse.

Who can join the trial?

8 criteria

  • 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 trial?

12 criteria

  • 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.
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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.

What is already known about the treatment

  • Atezolizumab

    This medication is administered as a liquid through an intravenous infusion into a vein. It is a well-established treatment used to help the body's immune system fight various types of advanced cancer. This drug works by attaching to specific proteins on immune cells, which helps these cells recognize and attack cancer cells more effectively. It is classified as an immunotherapy agent.

  • YL201

    This substance is delivered to the patient through an intravenous infusion into a vein. It is currently an experimental drug being studied in clinical trials to see how well it works against advanced solid tumors. The medication is designed to target specific molecules in the body to disrupt cancer growth or improve the immune response. It is classified as a targeted therapy under investigation.

Investigated diseases

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 detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-523742-27-00Protocol codeYL201-INT-102-02Estimated enrolment243 patientsSponsorMedilink Therapeutics (Suzhou) Co. Ltd.

sourced from the EU Clinical Trials Register and site verification

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