AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas

Researchers are conducting a study to test a new medicine called Risvutatug Rezetecan. This study is for adults aged 18 and over who have a type of cancer called sarcoma. Specifically, it's for people whose sarcoma is advanced, meaning it cannot be surgically removed or has spread to other parts of the body, and who have already tried other treatments. The main goals are to find out how safe the new medicine is and how effective it is in shrinking the cancer or stopping it from growing for a period of time. This is an early-stage study, combining two phases, to gather important information about this potential new treatment.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

27 May 2026

Sarcoma

What is this study about?

This study is testing a new drug called Risvutatug Rezetecan for a serious type of cancer known as sarcoma. Sarcomas are rare cancers that can affect bones, muscles, fat, blood vessels, or other soft tissues. For some people, sarcoma can be advanced, meaning it has grown significantly, or it has spread to other parts of the body (this is called metastatic sarcoma). When it's in this advanced stage, it might not be possible to remove it with surgery.

This particular study is designed for patients who have already received other treatments for their sarcoma, but those treatments haven't worked well enough or the cancer has returned. The main aim is to see if Risvutatug Rezetecan can help control the cancer, shrink it, or stop it from growing further. It also carefully checks for any side effects the new drug might cause.

This is a combination of 'Phase 1' and 'Phase 2' of a clinical trial. Phase 1 trials are about finding a safe dose and understanding how a new drug works in the body. Phase 2 trials then test if the drug is effective against the disease. By combining these, researchers hope to get answers more quickly about this potential new treatment for sarcoma.

Key takeaways

New drug called Risvutatug Rezetecan is being tested.
For adults with advanced or spread sarcoma.
Participants must have tried previous treatments.
Aiming to see if the drug is safe and effective.
Study involves regular appointments for monitoring.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older. It's open to both men and women.

You would be considered for this study if you have sarcoma that is advanced, meaning it can't be removed by surgery or it has spread to other parts of your body. Importantly, you must have already tried other standard treatments for your sarcoma, and it has either not responded well or has started to grow again.

There will be other detailed medical criteria that your doctor will check to make sure the study is a safe and appropriate option for you. This often includes looking at your general health, other medical conditions, and previous treatments.

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 18 years old or older?
Do you have advanced sarcoma that cannot be surgically removed or has spread?
Have you already received other treatments for your sarcoma?
Are you able to attend regular hospital/clinic appointments for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new study drug, Risvutatug Rezetecan. The study involves regular visits to the hospital or clinic for blood tests, scans (like CT or MRI scans) to monitor your sarcoma, and detailed health checks. These appointments are important for the research team to understand how the drug is affecting you and your cancer. You'll be closely monitored for any side effects and your general well-being.

The frequency of visits might be more intensive at the beginning of the study and then become less frequent over time. The total duration of your participation would depend on how well you respond to the treatment and the study plan, but detailed follow-up will continue even after you stop taking the study drug.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive a new treatment before it's widely available, which might be beneficial if other treatments haven't worked for you. However, new drugs can have side effects that are not fully known yet, and there's no guarantee the treatment will work for everyone. The research team will carefully monitor you for any side effects. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is sarcoma?

Sarcoma is a rare type of cancer that grows in the body's soft tissues (like fat, muscle, nerves, blood vessels) or in bones.

What does 'advanced or metastatic' mean?

It means the cancer has spread from where it started to other parts of the body, or it's grown significantly and can't be removed with surgery.

What is Risvutatug Rezetecan?

It's the name of the new experimental drug being tested in this study for sarcoma. It's not yet approved for general use.

Why is this a 'Phase 1b/2' study?

It means the study is in early stages, combining tests to find a safe dose (Phase 1b) with tests to see if the drug works (Phase 2) to get answers faster.

Will I get a placebo (dummy drug) in this study?

The information provided doesn't mention a placebo arm. This study is testing the new drug directly in patients who have already had previous treatments.