RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)

This study is looking into a new medicine called Risvutatug Rezetecan, or Ris-Rez for short. We want to find out if it's a safe and helpful treatment for young people (aged 12 and over) and adults who have certain types of advanced cancer. Specifically, it's for those with osteosarcoma (a type of bone cancer) or soft tissue sarcoma (cancer in soft parts of the body like muscles or fat). For this study, the cancer must have already been treated, but has come back or spread, and can't be removed with an operation. We’ll be checking how well people tolerate the medicine, how their bodies use it, and if it can help slow down or shrink the cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

Start

22 Jun 2026

Estimated completion

23 Nov 2029

Sarcoma

What is this study about?

This research is focused on a new medicine called Risvutatug Rezetecan, which we'll call Ris-Rez. The main purpose is to carefully check if this medicine is safe to use and if it can help people who have certain types of cancer. We'll also be learning how the body processes the medicine, like how it's absorbed and broken down, which is important for understanding how it works.

The study is for adolescents (teenagers aged 12 and older) and adults who have advanced sarcomas. Sarcomas are rare types of cancer that start in different parts of the body. The study specifically includes two main types: osteosarcoma, which is a cancer that starts in the bones, and soft tissue sarcoma, which can start in muscles, fat, nerves, or other soft tissues. For people to be considered for this study, their cancer must have already been treated before, but unfortunately, it has either come back or spread to other parts of the body, and doctors have said it can't be removed by surgery.

Taking part in this study means you would be trying a new medicine that isn't yet widely available. By carefully observing how your body responds to Ris-Rez, doctors can learn more about its potential benefits and any side effects. This information helps us understand if Ris-Rez could become a new treatment option for people with advanced sarcomas in the future.

Key takeaways

This study is testing a new medicine (Ris-Rez) for advanced bone or soft tissue cancers.
It's for teenagers (12+) and adults whose cancer has returned, spread, and can't be operated on.
The main goals are to check the medicine's safety, how well it works, and how the body handles it.
Participation involves regular hospital visits for treatment and check-ups.
There are potential benefits (access to new treatment) and risks (side effects, uncertainty of effectiveness).
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, there are certain things doctors will check to make sure it's the right fit for you. You must be at least 12 years old. You need to have been diagnosed with advanced osteosarcoma (bone cancer) or soft tissue sarcoma, which means the cancer can't be removed by surgery or has spread to other parts of the body. Also, your cancer must have gotten worse after at least one previous treatment.

Your general health needs to be good enough to take part. This means your body's organs, like your liver and kidneys, need to be working well. Doctors will also assess your overall ability to do daily activities. Before starting, you, or your parent or legal guardian if you're under 16, will need to fully understand the study and sign a consent form saying you agree to take part.

There are also some reasons why you wouldn't be able to join. For example, if you've already had a similar type of drug called an Antibody-Drug Conjugate that works in a particular way. You also can't join if you have serious, uncontrolled heart problems, certain active infections like HIV, or if the cancer has spread to your brain causing symptoms. If you're pregnant or breastfeeding, you won't be able to take part either.

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 12 years old?
Do you have advanced osteosarcoma or soft tissue sarcoma that has returned or spread?
Has your cancer gotten worse after at least one previous treatment?
Are your major organs (like liver, kidneys) working well?
Are you able to do most of your daily activities without much trouble?
Are you *not* pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the new medicine, Ris-Rez, and another medicine called G-CSF, which helps your body make white blood cells. This is given to you by the study doctors. You'll have regular visits to the hospital or clinic for check-ups, which will include blood tests, scans, and other tests to see how you're responding to the treatment and to monitor your health. These visits will help the doctors understand how the medicine is working and if there are any side effects.

The study involves taking the medicine for a certain period, and then doctors will continue to follow your health and progress even after you finish taking the study medicine. The exact number of visits and the total length of time you'll be involved can vary, but the study team will explain all of this in detail before you make any decisions. You'll always have the right to ask questions and discuss anything with the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment (Ris-Rez) that isn't widely available, which might help your condition. You'll also receive close medical attention and monitoring. However, there are potential risks, including side effects from the new medicine, which can sometimes be serious, and it's not guaranteed that the treatment will be effective for everyone. As with any new medicine, all possible side effects may not be fully known yet. You will be told about all known and potential risks before you decide to join. It is very important to remember that participating in any clinical study is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (13)

GSK Investigational Site
Verified postcode
West Valley City, United States· Recruiting
GSK Investigational Site
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Toronto, Canada· Recruiting
GSK Investigational Site
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Montreal, Canada· Recruiting
GSK Investigational Site
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Bordeaux, France· Recruiting
GSK Investigational Site
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Lyon, France· Recruiting
GSK Investigational Site
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Villejuif, France· Recruiting
GSK Investigational Site
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Jerusalem, Israel· Recruiting
GSK Investigational Site
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Tel Aviv, Israel· Recruiting
GSK Investigational Site
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Fukuoka, Japan· Recruiting
GSK Investigational Site
City only
Hokkaido, Japan· Recruiting
GSK Investigational Site
Verified postcode
Tokyo, Japan· Recruiting
GSK Investigational Site
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is Ris-Rez?

Ris-Rez is the shorter name for Risvutatug Rezetecan, a new medicine being tested in this study for certain types of advanced cancer.

What types of cancer is this study for?

This study is for people with advanced osteosarcoma (bone cancer) or soft tissue sarcoma, where the cancer has come back, spread, and can't be removed by surgery.

What does 'advanced' cancer mean in this study?

It means the cancer has either returned or spread to other parts of the body, and doctors have determined it cannot be removed with an operation.

Will I get other treatments while in the study?

You'll receive Ris-Rez and G-CSF as part of the study. Other treatments might not be allowed alongside the study medicine; this will be explained by the study team.

Can I leave the study if I change my mind?

Yes, taking part is completely voluntary. You can decide to leave the study at any time, for any reason, and it won't affect your regular medical care.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

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