Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An Open-label, Single Agent, Phase I/II Trial Investigating the Safety and Efficacy of RVU120 (SEL120) in Patients with Relapsed / Refractory Metastatic or Advanced Solid Tumors

This research is looking at a new drug called RVU120 (also known as SEL120) for people living with advanced cancer. This means the cancer has either returned after previous treatments or has spread to other parts of the body. The main goal of the study is to find out if RVU120 is safe to use and at what amount (dose) it works best. Doctors will also be checking to see if the drug helps to shrink tumours or slow down the cancer's growth. It's an 'open-label' study, which means both you and your doctors will know you are receiving the new medicine. This is an early-stage trial, so it's common for new treatments to be tested to understand their effects carefully.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ryvu Therapeutics S.A.

Enrolment target

Start

18 Jul 2024

Relapsed / Refractory Metastatic or Advanced Solid Tumors

What is this study about?

This study is investigating a new treatment named RVU120 (also called SEL120) for advanced solid tumours. 'Solid tumours' are cancers that form a lump, unlike blood cancers. 'Advanced' means the cancer may have spread or come back after previous treatments. The researchers want to learn if RVU120 can be a safe and effective option for patients in this situation.

This research is split into two main parts. The first part, called Phase I, is about finding the right dose of the drug. Doctors will give different amounts of RVU120 to small groups of patients to see what dose is safe and well-tolerated. They'll be carefully watching for any side effects. The second part, Phase II, will then use this best dose in more patients to see how well it works against the cancer and continue monitoring safety.

The main things doctors will look for are how often side effects happen and how serious they are. They will also measure if tumours get smaller, how long patients respond to the treatment, and overall how long patients live. These measurements help them understand if RVU120 is helping patients. This kind of study is crucial for developing new cancer treatments.

Key takeaways

This study is testing a new drug (RVU120) for advanced solid tumours.
It's for people whose cancer has come back or spread after other treatments.
The main goals are to find a safe dose and see if the drug works against cancer.
Both patients and doctors will know that the new drug is being given.
Participation involves regular clinic visits for tests and monitoring.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

The specific type of cancer you have is important – it needs to be an 'advanced solid tumour'. This means it's a cancer that forms a lump, and it has either spread to other parts of your body (metastatic) or has come back after you've already had other treatments (relapsed/refractory). This study is for people who have already tried other treatments that haven't worked or stopped working.

There will be other detailed health checks to make sure your body can handle the new treatment, such as certain blood test results and how well your organs are working. The study team will review all your medical information to confirm if you are a good fit for the trial.

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 a solid tumour (a cancer that forms a lump)?
Has your cancer spread or come back after previous treatments?
Are you generally well enough to participate in a clinical study? (This will be assessed by doctors).

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, RVU120. You will have regular visits to the clinic so the medical team can monitor your health and how you respond to the treatment. These visits will involve physical examinations, blood tests, and scans (like CT or MRI) to check on your cancer.

The exact number and timing of visits will depend on which part of the study you are in. Initially, visits might be more frequent to closely monitor your reaction to the drug. The study will continue for as long as the treatment is helping you and you are not experiencing severe side effects. There will also be follow-up appointments after you stop taking the drug to monitor your health over time. The total duration of your participation will vary, but you will be fully informed about the schedule before you decide to join.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits. You would be among the first to receive this new treatment, which could potentially help if your current treatments are no longer working. However, as with any new medicine, there are also potential risks. You might experience side effects, some of which could be serious, and the treatment might not work for everyone. The study team will explain all known and possible side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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
Poland

Common questions

What is an 'advanced solid tumour'?

It's a type of cancer that forms a lump and has either spread to other parts of the body or has come back after previous treatments.

What does 'relapsed/refractory' mean?

It means your cancer has either returned after treatment or stopped responding to treatments you've tried before.

Is RVU120 a chemotherapy drug?

RVU120 is a new experimental drug, not a traditional chemotherapy. It works in a different way, which the researchers are testing.

Will I know if I'm getting the active drug?

Yes, this is an 'open-label' study, so both you and your doctors will know you are receiving RVU120.

How long will I be in the study if I join?

The length of time varies. You'll stay in the study as long as the drug is helping you and you're not having serious side effects, with follow-up after the treatment stops.