RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of YL201 in Patients With Advanced Solid Tumors

This study is looking into a new treatment called YL201 for people who have advanced solid tumours. These are cancers that have grown or spread and haven't gotten better with standard treatments, or where no standard treatment is available. The study is split into two main parts. The first part aims to find the safest and most effective dose of YL201. The second part will then use that dose in a larger group of patients to learn more about its safety and how well it works against different types of advanced solid tumours. Sometimes, YL201 might be given on its own, and other times it might be given together with another medicine called atezolizumab. This is an early-stage study being carried out in China and the United States.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Enrolment target

312

Start

25 May 2022

Estimated completion

06 Oct 2027

Advanced Solid Tumor

What is this study about?

This research study is all about a new medicine called YL201. It's designed for people who have advanced solid tumours – these are cancers that have grown or spread within the body and haven't responded to usual treatments, or where there aren't any standard treatments left to try. The main goals of the study are to see if YL201 is safe and tolerable, and to understand how well it works against these types of cancers.

The study has two main stages. In the first stage, a small group of patients will receive different doses of YL201 to help doctors figure out the best and safest amount to give. Once that ideal dose is found, the study moves into its second stage. Here, more patients with specific types of advanced solid tumours will receive YL201 at the chosen dose. This stage helps researchers gather more information on its safety and how effective it is in a larger group of people. Sometimes, YL201 will be given on its own, and in other cases, it might be given together with another medicine called atezolizumab.

This is what is known as a 'first-in-human' study, meaning it's one of the first times this new medicine is being tested in people. It's happening in hospitals in both China and the United States. Finding new and effective treatments for advanced cancers is really important, and studies like this help us learn more and potentially offer new options for patients in the future.

Key takeaways

This study is testing a new medicine called YL201 for advanced solid tumours.
It's for people whose cancers haven't responded to standard treatments.
The study aims to find a safe dose and see how well YL201 works.
You might receive YL201 alone or with another medicine called atezolizumab.
It's an early-stage study (Phase 1/2) happening in China and the US.
Participation involves regular visits, tests, and closely monitoring your health.

Who may be eligible?

To join this study, you must be at least 18 years old and have an advanced solid tumour. This means your cancer has spread or grown, and it hasn't responded to previous treatments, or there aren't any standard treatments available anymore. You should also be generally well enough to take part, meaning you can carry out most of your daily activities without too much trouble, and your organs like your liver, kidneys, and bone marrow are working adequately.

There are also some specific health checks that need to be met, and you must be expected to live for at least three more months. If you are a woman who could become pregnant or a man, you must agree to use effective birth control during the study and for a period afterwards. Everyone taking part needs to be able to come to study visits and follow the instructions given.

You won't be able to join if you're already in another clinical trial (unless it's just for observation or follow-up) or if you've recently had certain cancer treatments within a few weeks of starting this study. Your study doctor will review all your health information to confirm if this study is suitable for you.

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.

Are you at least 18 years old?
Do you have an advanced solid tumour that hasn't responded to other treatments?
Are you generally well enough to manage most daily activities?
Are you able and willing to attend regular hospital visits and follow study instructions?
Are you able to use effective birth control if you are of childbearing potential?
Have you recently stopped any other cancer treatments (your doctor will check the exact timing)?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you'll have various tests and check-ups to monitor your health and see how you're responding to the treatment. This might include blood tests, scans (like CT scans) to measure your tumour, and physical examinations. You'll also receive the study medicine, YL201, and possibly atezolizumab, which will be given according to a set schedule. Doctors and nurses will watch you closely for any side effects.

The study is split into two parts. Firstly, a 'dose escalation' part where different doses of YL201 are tested to find the safest and most effective one. Then, a 'dose expansion' part with more patients using that chosen dose. You'll need to follow the study schedule, attend all appointments, and let the study team know about any changes in your health. The total time you spend in the study will vary, depending on how you respond to the treatment and the phase of the study you are in, but there will be a follow-up period even after you finish taking the medicine.

Potential risks and benefits

While we hope that YL201 could help fight your cancer or slow its growth, there's no guarantee it will work for everyone, or at all. The potential benefits are that it might offer a new treatment option for your advanced solid tumour, especially if other treatments haven't worked. However, like all medicines, YL201 can have side effects, and some may be serious. The study team will closely monitor you for any side effects and manage them as best they can. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (45)

002
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Fair Oaks, United States· Recruiting
001
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La Jolla, United States· Recruiting
003
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Lone Tree, United States· Recruiting
004
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Washington D.C., United States· Recruiting
005
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Boston, United States· Recruiting
006
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Ann Arbor, United States· Recruiting
007
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Detroit, United States· Recruiting
008
Verified postcode
St Louis, United States· Recruiting
009
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Santa Fe, United States· Recruiting
010
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New York, United States· Recruiting
011
Verified postcode
Chapel Hill, United States· Recruiting
012
Verified postcode
Nashville, United States· Recruiting

Common questions

What type of cancer is this study for?

This study is for people with advanced solid tumours, which are cancers that have spread or grown and haven't responded to usual treatments.

What is YL201?

YL201 is a new medicine being tested as a treatment for advanced solid tumours. This is an early study to see if it's safe and how well it works.

Will I get YL201 on its own or with other medicines?

You might receive YL201 on its own, or sometimes it will be given together with another medicine called atezolizumab. Your study doctor will explain what treatment plan applies to you.

What does 'Phase 1/2' study mean?

It means the study is in its early stages. Phase 1 is about finding a safe dose, and Phase 2 gathers more information on its safety and how well it works.

Where is this study taking place?

This study is being conducted in medical centres in both China and the United States.

How to find out more

Sasha Stann

info@medilinkthera.com 617-240-8494 Official trial record

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