Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Multicenter, Open-Label, Phase I/II Study of EOS884448 in combination with standard of care and/or investigational therapies in participants with advanced solid tumors

This research study is looking into new treatment combinations for people with advanced solid cancers. It's split into two main parts. The first part focuses on finding the safest dose of the new medicines by carefully checking for any side effects. The second part then looks at how effective these doses are at shrinking or controlling the cancer. We're also checking how the body reacts to the medicines and if there are any antibodies formed against them. The goal is to see if combining these treatments can offer a better way to fight advanced cancers. It involves careful monitoring by doctors to ensure safety and understand how the treatments work.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

iTeos Belgium

Enrolment target

206

Start

13 Nov 2024

Advanced solid tumors

What is this study about?

This important research study is looking for new and better ways to treat advanced solid cancers. When we say 'advanced solid cancers,' we mean cancers that have grown or spread in the body. The study is testing a new medicine called EOS884448 in combination with other existing cancer treatments like JEMPERLI and KEYTRUDA, and another investigational drug called Inupadenant. These are all types of immunotherapy or similar treatments that help your body's immune system fight cancer.

The study has two main steps. The first step, called 'Dose Finding,' is all about safety. Doctors will carefully give different amounts of the new medicines to check for any side effects and find the dose that is safest for patients. They'll be watching blood tests, heart checks, and general well-being very closely. Once a safe dose is found, the second step, called 'Expansion,' will look at how well that safe dose works. This means checking if the cancer shrinks, stops growing, or if the treatment helps you live longer without the cancer getting worse. The study will also look at how your body handles the medicines.

By combining these different treatments, researchers hope to boost the body's natural ability to fight cancer. The medicines used in this study are often given as an injection or infusion (into a vein). It's a key step in developing new therapies to improve the lives of people living with advanced solid cancers.

Key takeaways

This study is for adults with advanced solid cancers.
It's testing a new medicine in combination with existing cancer therapies.
The main goals are to find a safe dose and see how well the treatment works.
You will be closely monitored for safety and treatment effectiveness.
Participation involves regular hospital visits, treatments, and tests.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older.

Doctors will carefully check your medical history and current health to make sure this study is right for you and that taking part would be safe. There will be specific health requirements, like certain blood test results or how well your organs are working, to ensure you can safely receive the study treatments. You will also need to have a type of solid cancer that is considered 'advanced' by the study doctors.

The research team will explain all the requirements in detail and answer any questions you have to help you understand if you might be a good fit for this particular 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.

Are you 18 years old or older?
Have you been diagnosed with an advanced solid cancer?
Are you well enough to participate in a clinical trial, as decided by a doctor?
Are you able to attend regular hospital appointments and tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it would involve regular visits to the hospital or clinic. During these visits, doctors and nurses would perform various checks, including physical examinations, taking blood and urine samples, and performing heart tests like an ECG (a simple test to check your heart's electrical activity). You would also have scans to see how your cancer is responding to the treatment.

The study treatments, which include EOS884448 and other medicines like JEMPERLI, KEYTRUDA, and Inupadenant, would be given to you as infusions (into a vein) or other specific methods as instructed by the study team. You would receive these treatments on a set schedule over several weeks or months. The total duration of your participation in the study would depend on how your cancer responds to the treatment and what the study doctors decide is best for you, both during the treatment period and a follow-up period to monitor your health.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that you might receive a new treatment or combination of treatments that could help control your cancer, which might be more effective than standard treatments. However, there's no guarantee the treatment will work for you. Potential risks include experiencing side effects from the medicines, which can range from mild (like tiredness or sickness) to more serious reactions requiring treatment or hospitalisation. You will be closely monitored for any side effects. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (4)

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

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Unverified
Italy
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Unverified
France
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Unverified
Belgium
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Unverified
Spain

Common questions

What does 'advanced solid tumors' mean?

It refers to cancers that have grown beyond their original location or have spread to other parts of the body.

What kind of medicines are being tested?

The study is testing a new drug called EOS884448 along with existing cancer treatments (like JEMPERLI and KEYTRUDA) and another investigational drug (Inupadenant), which often work by helping your immune system fight cancer.

What is the difference between Phase I and Phase II?

Phase I trials mainly focus on finding a safe dose and understanding side effects. Phase II trials then look at how well that safe dose works to treat the cancer.

Will I know if the treatment is helping my cancer?

Yes, doctors will use scans and other tests to see if your cancer is shrinking, staying the same, or growing, and they will discuss these results with you.

Can I stop participating in the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without affecting your usual medical care.