Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumors

This study is looking at a new treatment called RP3, both on its own and combined with another medicine called Nivolumab. It's for people who have advanced solid tumours, which are cancers that have grown or spread. This is a very early-stage study, meaning it’s the first time these treatments are being tested in people. The main aim is to understand if they are safe and what happens in the body when they are given. Researchers want to see how patients react to the medicines and check for any side effects. This step is crucial for developing potential new cancer treatments in the future, by carefully checking how these new medicines work in humans for the very first time.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Replimune Group Inc.

Enrolment target

Start

02 Dec 2024

Advanced solid tumors

What is this study about?

Imagine scientists have developed a brand new key that they hope can unlock ways to fight cancer. Before they can use this key widely, they need to very carefully test it to make sure it works as expected and is safe. That's what this study is all about.

This research is looking at a new medicine called RP3. Sometimes, it will be given by itself. Other times, it will be given along with another established cancer medicine called Nivolumab. The study is for people who have advanced solid tumours. This means their cancer has grown or spread, and often, other treatments might not have worked as well as hoped.

Because this is such an early stage – it's the very first time these treatments are being given to people – the main goal is to understand how safe they are and how the body reacts to them. Researchers will be looking very closely at how the medicines are handled by the body, checking for any side effects, and generally making sure that the treatment is manageable for patients. This careful first step is vital for future research that could potentially lead to new and effective treatments for cancer.

Key takeaways

This study tests a brand new cancer medicine, RP3.
It's for adults with advanced solid tumours.
The main goal is to check for safety and side effects.
It's a very early-stage trial ('Phase I').
You might receive RP3 alone or with another medicine, Nivolumab.
Participation helps scientists learn about potential future treatments.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part if they meet other criteria.

This study is open to both men and women. The specific type of advanced solid tumour you have will be very important, as will your general health and whether you've tried other cancer treatments. The research team will review all your medical information carefully to see if this study is suitable for you.

It's important to remember that joining a clinical study has very specific requirements. These are put in place to ensure your safety and to make sure the study results are clear. Your doctor will be able to explain if your health and medical history match what the researchers are looking for.

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?
Are you generally well enough to participate in a study?
Are you willing to have regular hospital visits and tests?
Are you prepared for an experimental treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, RP3 (either on its own or with Nivolumab), according to a specific plan. This will involve regular visits to the hospital or clinic. During these visits, the research team will perform various tests such as blood tests, physical examinations, and possibly scans, to monitor your health and how you respond to the treatment. They will also carefully check for any side effects you might experience. You'll likely have follow-up appointments after you stop taking the treatment to make sure you're doing well. The total duration of your participation, including treatment and follow-up, will be clearly explained by the study team.

Potential risks and benefits

Participating in an early-stage study like this means there's a chance you could be among the first to receive a new treatment that might help your condition, although there's no guarantee. You would also be contributing valuable information that could help others in the future. However, because this is a new medicine, there are unknown risks, and you might experience side effects that we don't fully understand yet. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
France
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Unverified
Greece

Common questions

What does 'advanced solid tumours' mean?

It means the cancer is a solid growth in the body that has either grown beyond its original site or has spread to other parts of the body.

What is 'Phase I'?

Phase I is the very first step of testing a new medicine in people. It mainly checks if the medicine is safe and what doses can be given.

Is RP3 a known medicine?

RP3 is a new medicine being tested. Its effects are not fully known yet, which is why this study is so important.

What is Nivolumab?

Nivolumab is an existing cancer medicine used to help the body's immune system fight cancer.

Will I get better if I join this study?

No one can guarantee that you will get better. The main aim of this early study is to see if the treatment is safe, not necessarily to cure your cancer.