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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

This research study is investigating a new treatment called YL201, used in combination with an established cancer drug, atezolizumab. It's for people with advanced solid tumours, specifically focusing on extensive-stage small cell lung cancer. The study has two main parts. The first part aims to find a safe dose of YL201 when given with atezolizumab. The second part will then look more closely at how well different doses work and are tolerated. The goal is to see if this new combination can be a helpful treatment option. Patients will continue treatment as long as it's working for them and they are not experiencing severe side effects.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Enrolment target
118
Start
31 Mar 2026
Estimated completion
01 Feb 2029

What is this study about?

This study is looking into a new medicine, which we'll call YL201, to see how it works when combined with another treatment called atezolizumab. These medicines are for people who have cancer that has spread, particularly a type of lung cancer known as extensive-stage small cell lung cancer.

The main aim is to understand if YL201 can be safely given at different doses alongside atezolizumab, and to find out which dose is best. We also want to see if this combination helps to treat the cancer. This is a common way new treatments are tested to make sure they are safe and potentially effective before they can be widely used.

The study is split into two phases. The first phase is about carefully increasing the dose of YL201 to see what people can safely take. Once the best dose is found, the second phase will then check how well it works for a larger group of people. This careful approach helps researchers learn if the new treatment has a role in managing this type of cancer.

Key takeaways

  • It's a study for advanced small cell lung cancer.
  • It tests a new drug (YL201) with an existing one (atezolizumab).
  • Aims to find a safe dose and see how well the combination works.
  • Participation involves regular clinic visits for treatment and monitoring.
  • You can stop participating at any time.
  • Potential benefits and risks will be discussed in detail.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with extensive-stage small cell lung cancer that has been confirmed by lab tests. You also need to be generally well enough to take part, meaning you can mostly look after yourself and manage daily activities without too much help. Your blood tests and organ functions, like your kidneys and liver, should also be working well enough.

There are also some reasons why you might not be able to join. For example, if you've already had certain anti-cancer treatments for your current lung cancer, or if you've had treatments that target specific proteins called B7H3 or topoisomerase I. People with active cancer in the brain or spine, or who have certain lung conditions like interstitial lung disease, would also not be able to participate. Serious heart problems might also prevent you from joining this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have extensive-stage small cell lung cancer?
  3. Are you generally well and able to manage daily activities?
  4. Have you *not* had prior treatment for your current extensive-stage small cell lung cancer?
  5. Do you have good kidney, liver, and blood function?
  6. Do you *not* have active cancer spread to the brain or spine, or serious heart or lung conditions?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the study medicines, YL201 and atezolizumab, usually given through a drip (infusion) into a vein. The exact schedule will vary based on which part of the study you are in, but these treatments are generally given every three weeks.

You'll have regular visits to the clinic for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. The study will continue for as long as the treatment is helping your cancer and you are tolerating it well. If your cancer starts to progress, or if you experience side effects that are too severe, or if you simply wish to stop, your participation in the study treatment would end. The total duration of your involvement in the study will depend on how your body responds to the treatment.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. The potential benefit of joining this study is that you might gain access to a new treatment combination that is not yet widely available and could help to control your cancer. However, there's no guarantee it will work for you. Like all medicines, YL201 and atezolizumab can cause side effects, some of which might be unpleasant or serious. The study team will carefully monitor you for these and will be there to support you. Please remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Site 1001
    Verified postcode
    Washington D.C., United States· Not yet recruiting
  • Site 1005
    Verified postcode
    Houston, United States· Recruiting
  • Site 1002
    Verified postcode
    Fairfax, United States· Recruiting
  • Site 2201
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What type of cancer is this study for?

This study is specifically for people with extensive-stage small cell lung cancer, which is a type of aggressive lung cancer that has spread.

What are the treatments involved?

You would receive two treatments: YL201, which is a new investigational drug, and atezolizumab, which is an existing cancer medicine.

How will the doctors know if the treatment is working?

The study team will perform regular scans and blood tests to monitor your cancer and see how it responds to the treatment.

Can I stop taking part in the study if I want to?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Will I have to pay to be in this study?

No, you will not have to pay for the study drugs or medical visits that are part of the trial.

How to find out more

MediLink Study Team

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of YL201 in Combination With Other Anti-Cancer Thera…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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