AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

RIVKAL clinical trial for the first-in-human administration of BIM2b in participants with Glioblastoma

The RIVKAL study is a new research project testing an investigational drug called BIM2b for the first time in people who have glioblastoma. Glioblastoma is a type of brain cancer. This is a very early stage of research, known as a Phase 1 study. The main goal is to check if the new medicine is safe and to understand how the body reacts to it, rather than to see if it cures the cancer at this stage. Researchers will also be looking to see what dose of the medicine might be best for future studies. People aged 18 and over, both men and women, with glioblastoma could be eligible to take part.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Beta Innov

Enrolment target

Start

09 Oct 2024

Glioblastoma

What is this study about?

The RIVKAL study is an important new research project looking at a medicine called BIM2b. This medicine has not been given to people before, so this study is the very first time doctors will be testing it in humans. The study focuses on people who have glioblastoma, which is a serious type of brain tumour. Because it's the first time, the main aim is to make sure the medicine is safe and to see how your body handles it, including how much of it stays in your system over time. This initial step is crucial for developing any new treatment.

This kind of study is called a 'Phase 1' clinical trial. It’s a very early stage of research, meaning there will be a lot of careful monitoring. Researchers are not expecting to cure glioblastoma at this point, but rather to gather essential information about the new medicine. This includes finding a safe dose to use in future studies and looking for any side effects.

The findings from the RIVKAL study will help doctors decide if BIM2b has the potential to be a helpful treatment for glioblastoma in the future. The information they gather will guide further research, hopefully leading to new options for patients.

Key takeaways

This is the first time the new medicine BIM2b is being tested in people.
The study focuses on safety and how the body handles the medicine in people with glioblastoma.
It's a very early-stage (Phase 1) clinical trial.
People aged 18 and older, both men and women, may be eligible.
Your participation could help develop future treatments for glioblastoma.

Who may be eligible?

To join the RIVKAL study, you must be at least 18 years old. Both men and women can take part in this research.

Because this is an early-stage study, there will be other specific health requirements to make sure it's safe for you to participate and that the study results are clear. For example, doctors will need to check your general health, make sure your organs like your liver and kidneys are working well, and that you haven't recently had other treatments that might interfere with the new medicine. You would need to discuss your full medical history with the study doctor.

The research team will carefully review your medical records and ask you questions about your health to see if this study is right for you. They will explain all the specific rules in detail.

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 glioblastoma?
Are you able to attend regular clinic visits?
Can you commit to the full study duration, including follow-up checks?
Are you willing to have necessary medical tests and share your health history?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the RIVKAL study, you would first go through a screening process. This involves medical tests like blood checks, scans, and a review of your health history to make sure you fit the study's requirements. If you are eligible, you would then receive the study medicine, BIM2b. Because this is the first time it’s being given to people, you would likely spend some time at the clinic at the beginning, possibly overnight or for several days, so doctors can carefully monitor you for any immediate effects.

During the study, you would have regular visits to the clinic. These visits will include checks of your blood, urine, and possibly scans, to see how the medicine is affecting your body and to monitor for any side effects. The doctors and nurses will ask you how you are feeling and keep a close eye on your health. You would continue to visit the clinic for treatments and follow-up checks for a set period, which the study team will explain fully. The total length of your participation would depend on the study plan, which includes the treatment period and follow-up to see how you are doing after stopping the medicine.

Potential risks and benefits

Potential benefits from taking part in this study are not known at this early stage. You might not directly benefit from receiving the new medicine, as the main goal is to find out if it's safe for people. However, by participating, you would be helping doctors learn more about glioblastoma and potentially contribute to developing new treatments for others in the future. As with any new medicine, there are potential risks, including side effects that are not yet known. The study team will explain all known possible side effects and closely monitor you for any others. You have the right 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 a 'Phase 1' study?

A Phase 1 study is the very first step where a new medicine is tested in people. The main goals are to check if it's safe and to see how the body handles it. It's not usually about curing the illness at this early stage.

Will this medicine cure my glioblastoma?

At this early stage, the study is focused on safety and understanding the medicine. It's not designed to cure glioblastoma, but the information gathered could help develop future treatments.

Do I have to pay to join the study?

No, you should not have to pay to participate in a clinical trial. All study-related treatments and assessments are usually covered by the study sponsors.

Can I stop participating if I change my mind?

Yes, absolutely. You can choose to leave the study at any time, for any reason, without your medical care being affected.

What is BIM2b?

BIM2b is the name of the new investigational medicine being tested for the first time in people in this study. It's currently an experimental treatment.