RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors

This study is investigating a new treatment called Mocertatug Rezetecan, or Mo-Rez for short. It's being tested in combination with other anti-cancer drugs, Dostarlimab and Bevacizumab, for people with advanced solid tumours – that means cancers which have spread to other parts of the body. Unfortunately, many existing cancer treatments stop working over time, and the cancer can return. The aim of this research is to find new ways to treat these cancers. Researchers want to understand how safe Mo-Rez is when given with other medicines, how the body handles it, and how well it helps control the cancer. This is for people whose current treatments haven't worked, who can't handle the side effects, or who don't have good treatment options left. It’s an early-stage study, in Phase 1 and Phase 2.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

305

Start

04 Mar 2025

Estimated completion

10 Oct 2028

Tumours, Gynecological

What is this study about?

When cancer spreads to other parts of the body, it’s called an advanced solid tumour. While there are many treatments available, over time, these treatments might stop working for some people, or the cancer might come back. This can be really disheartening, and doctors are always looking for new and better ways to help patients.

This study is looking at a new medicine called Mocertatug Rezetecan, or Mo-Rez. Instead of using just one medicine, researchers are exploring whether combining Mo-Rez with other cancer treatments, like Dostarlimab and Bevacizumab, could be more effective. The main aim is to understand how safe this combination of medicines is, how the body processes it, and how well it might work against advanced solid tumours. This is particularly for people who haven't responded well to standard treatments or who find them too difficult to cope with.

By taking part in this study, you would help doctors understand if this new combination has the potential to become a beneficial treatment option in the future. The information gathered from participants is crucial for developing new medicines that could help many others facing similar challenges with their cancer.

Key takeaways

This study is testing a new drug, Mo-Rez, in combination with other treatments.
It's for people with advanced solid tumours where standard treatments aren't working well.
The main goals are to check safety, how the body handles the drug, and how effective it is.
You'll need to be at least 18 and have a specific type of advanced tumour.
Tissue samples (from existing or new biopsies) are important for the research.
Participation involves regular clinic visits for monitoring and assessments.

Who may be eligible?

To join this study, you must be at least 18 years old. You need to have been diagnosed with an advanced solid tumour that has been confirmed by a doctor, and it needs to be the specific type of tumour the study is interested in. You also shouldn't have had more than four different types of cancer treatments before this study. Treatments given before or after surgery count as one course of treatment, and ongoing treatments that are part of a previous course don't count as extra. The researchers will also need to look at a small piece of your tumour tissue. This could be from a sample you've already had taken (like from a previous biopsy or surgery), or if that's not available or suitable, you might need to have a new biopsy. This tissue helps them understand more about your cancer and how the treatment might work. Finally, your cancer must have at least one measurable area that doctors can track to see if the treatment is working.

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 an advanced solid tumour that has been confirmed by a doctor?
Have you had four or fewer different types of cancer treatments before this?
Do you have a clear area of cancer that doctors can measure and track?
Are you able to provide a recent tumour tissue sample, or potentially have a new biopsy if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication (Mo-Rez) along with other anti-cancer therapies, as decided by the study doctors. You would have regular appointments at the clinic for assessments, which might include blood tests, scans, and physical examinations. These visits will help the doctors monitor your health, how you're responding to the treatment, and check for any side effects.

You would need to provide tissue samples for analysis, either from existing samples or potentially a new biopsy. The total duration of your participation would depend on how your body responds to the treatment and the study plan, which the study team will explain in detail. There will also be follow-up visits after your treatment finishes to monitor your long-term health.

Potential risks and benefits

Taking part in a clinical trial may offer the chance to access a new treatment that isn’t widely available, especially if your current treatments aren’t working or you have limited options. However, there's no guarantee the treatment will work for you, and like all medicines, the study drugs may cause side effects, some of which could be serious or unexpected. The research team will carefully monitor you throughout the study and explain all known risks. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (78)

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

GSK Investigational Site
Verified postcode
La Jolla, United States· Recruiting
GSK Investigational Site
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Rochester, United States· Recruiting
GSK Investigational Site
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Durham, United States· Recruiting
GSK Investigational Site
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Columbus, United States· Recruiting
GSK Investigational Site
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Buenos Aires, Argentina· Recruiting
GSK Investigational Site
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Buenos Aires, Argentina· Recruiting
GSK Investigational Site
Unverified
CABA, Argentina· Recruiting
GSK Investigational Site
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Viedma, Argentina· Recruiting
GSK Investigational Site
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Liverpool, Australia· Recruiting
GSK Investigational Site
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Wollongong, Australia· Recruiting
GSK Investigational Site
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Brussels, Belgium· Recruiting
GSK Investigational Site
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Ghent, Belgium· Recruiting

Common questions

What is an advanced solid tumour?

An advanced solid tumour is a type of cancer that started in a solid organ (like the breast, lung, or bowel) and has spread to other parts of your body.

What is Mo-Rez?

Mo-Rez is an experimental new medicine that researchers are testing to see if it can help treat advanced solid tumours when combined with other cancer drugs.

Why are combinations of medicines being tried?

Sometimes, combining different medicines can be more effective than using just one, especially if your cancer has become resistant to existing treatments. Researchers are hoping this combination will work better.

Will I have to have a new biopsy?

You might need a new biopsy if there isn't a suitable recent tissue sample from your cancer readily available from earlier procedures. The study team will discuss this with you.

Can I stop participating in the study if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your ongoing 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.