AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1, multicenter, open-label study of REM-422, a MYB mRNA degrader, in patients with recurrent or metastatic, adenoid cystic carcinoma.

This research study is looking at a new medicine called REM-422. It's for adults who have adenoid cystic carcinoma (ACC), a type of cancer that has either returned after treatment or spread to other parts of the body. This is a very early study, called a Phase 1 trial, which means it’s the first time this specific drug is being given to people. The main goals are to check if the medicine is safe, to understand any side effects it might have, and to see how the body handles it. Doctors will also start to look for early signs of whether the medicine could be helpful in treating ACC. The study is open to both men and women aged 18 and over.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Remix Therapeutics Inc.

Enrolment target

Start

06 May 2024

Adenoid cystic carcinoma (ACC)

What is this study about?

This study is exploring a new potential treatment for a specific type of cancer called adenoid cystic carcinoma (ACC). ACC is a rare cancer that often starts in the glands, such as those in the head and neck. For some people, this cancer can come back after treatment or spread to other areas of the body. When this happens, doctors are always looking for new and more effective ways to help patients.

The new medicine being tested is called REM-422. It works by targeting something inside cancer cells called MYB mRNA. Think of MYB mRNA as a set of instructions that tells the cancer cell to grow. REM-422 aims to break down these instructions, which could stop the cancer cells from growing or even make them shrink. This study is exciting because it uses a new approach to try and fight this cancer.

Because this is a very early study, called a Phase 1 trial, it's the first time REM-422 is being given to human volunteers. The main purpose of this stage is not to cure the cancer, but to carefully check a few important things. Doctors want to make sure the medicine is safe to use, find the right dose, understand any side effects it might cause, and see how the body processes the drug. Once they have a good understanding of its safety, they can then move on to larger studies to see how well it works.

Key takeaways

This is an early-stage study (Phase 1) for a new cancer medicine.
The medicine, REM-422, is for specific patients with adenoid cystic carcinoma (ACC).
The main goals are to check the drug's safety and how it works in the body.
Participation involves regular clinic visits for treatment and monitoring.
Potential benefits include access to a new treatment, but there are also risks of side effects.
You can stop participating at any time.

Who may be eligible?

This study is looking for adult patients who have been diagnosed with adenoid cystic carcinoma (ACC). Specifically, your cancer needs to have either come back after previous treatment or have spread to other parts of your body.

You must be at least 18 years old to take part. The study is open to both men and women.

There will also be other specific medical requirements that your doctor will need to check. These include things like your overall health, other medical conditions you might have, and any previous treatments. These checks are important to make sure it's safe for you to take part and that the study results are clear.

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 adenoid cystic carcinoma (ACC)?
Has your ACC come back after treatment or spread to other parts of your body?
Are you willing to attend regular hospital or clinic visits?
Are you able to understand and sign the consent form?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have several tests to make sure you're suitable. Once enrolled, you would receive the study medication, REM-422, which will likely be given over a period of time. You'd have regular visits to the hospital or clinic for these treatments and for check-ups. During these visits, doctors and nurses would monitor your health very closely. This includes taking blood samples, performing scans, and asking about any side effects you might be experiencing. The number of visits and the overall length of your participation would depend on how your body responds to the treatment and the study plan, but Phase 1 studies often involve ongoing monitoring for several months.

Potential risks and benefits

Participating in a clinical trial like this could potentially offer benefits, such as access to a new medicine not yet widely available, and the chance to contribute to medical knowledge. However, because this is a new drug, there are risks of unknown side effects, which could range from mild to serious. It's important to understand that there is no guarantee the medicine will improve your condition. 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 adenoid cystic carcinoma (ACC)?

ACC is a rare type of cancer that often starts in the glands, like those in your head and neck, but can also occur in other parts of the body.

What does 'Phase 1 study' mean?

A Phase 1 study is the first time a new medicine is tested in people. Its main goal is to check for safety, find the right dose, and understand how the body handles the medicine.

What is REM-422?

REM-422 is the new experimental medicine being tested. It's designed to stop cancer cells from growing by breaking down specific instructions (MYB mRNA) within them.

Will REM-422 cure my cancer?

In a Phase 1 study, the main aim is safety and understanding the drug. While there's always hope, it's too early to know if REM-422 will cure cancer. Early signs of its effect on cancer will be looked for.

What if I change my mind about participating?

You can decide to leave the study at any point, for any reason, without impacting your current medical care. This is entirely your right.