RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma

This study is looking into a new treatment called REM-422 for Adenoid Cystic Carcinoma (ACC). This is a type of cancer that may have returned after treatment, spread to other parts of the body, or cannot be removed with surgery. Researchers want to find out if REM-422 is safe for patients and if it can help stop the cancer from growing or even shrink it. The study has two main parts: first, finding the best and safest dose of REM-422, and then, checking how well that dose works and if it's still safe for more people with ACC. Patients will continue in the study until their cancer gets worse, they can't handle the treatment anymore, or they decide to stop.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Remix Therapeutics

Enrolment target

100

Start

20 Dec 2023

Estimated completion

01 Jun 2027

Adenoid Cystic Carcinoma Metastatic Adenoid Cystic Carcinoma Recurrent Adenoid Cystic Carcinoma

What is this study about?

This research study is about a new medicine called REM-422 for people who have a specific type of cancer known as Adenoid Cystic Carcinoma (ACC). This is a cancer that can appear in different parts of the body, often in glands in the head and neck. We are focusing on patients whose ACC has either come back after previous treatment, spread to other areas of the body, or cannot be removed through surgery.

The main goal of this study is to understand two important things about REM-422: how safe it is for patients to take, and whether it has a positive effect on the cancer. REM-422 is designed to specifically target and reduce certain signals within cancer cells that are thought to help them grow. By reducing these signals, we hope to slow down or even shrink the cancer.

The study has two main steps. In the first step, a small group of patients will slowly increase their dose of REM-422. This helps the study team find the highest dose that is safe and can be continued in the next part of the study. Once the safest dose is found, a larger group of patients will receive this dose to further check its safety and see how well it works against the cancer. Understanding both the safety and effectiveness of new medicines is crucial for developing better treatments for cancer patients.

Key takeaways

This study is testing a new medicine (REM-422) for advanced Adenoid Cystic Carcinoma (ACC).
Its main aim is to check the medicine's safety and see if it helps shrink the cancer.
The study involves finding the best dose, then testing it in more patients.
Participation includes regular check-ups and monitoring.
You can stop participating at any time.
This is an early-stage study, so the full benefits and risks are still being discovered.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of Adenoid Cystic Carcinoma (ACC). This includes ACC that has come back, spread, or can't be surgically removed. Your cancer must also be showing signs of growth or causing symptoms. In some parts of the study, we'll need to confirm that your tumour has a specific marker we are looking for.

Your general health and daily activity level will also be checked. For example, you should be able to look after yourself and do light activities. We will also need to review some tissue samples from your cancer, either recent ones or older samples from the past six years, to understand it better. Before starting the new treatment, there might be a short break required from any other cancer treatments you've had recently.

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 diagnosis of Adenoid Cystic Carcinoma (ACC) that has come back, spread, or can't be removed?
Is your ACC currently showing signs of growth or causing symptoms?
Are you generally able to perform your daily activities without much difficulty?
Do you have available tissue samples from your cancer (either recent or from the last 6 years)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, REM-422. The study will continue for you until your cancer shows signs of getting worse, you can no longer tolerate the treatment due to side effects, or you choose to withdraw. During this time, you will have regular visits with the study team. These visits will involve various tests, such as blood tests, scans, and physical examinations, to monitor your health and how the treatment is affecting your cancer. In some cases, we may also ask for a new small tissue sample (biopsy) during the study to learn more about how the medicine is working. The study team will explain the exact schedule of visits and tests to you in detail.

Potential risks and benefits

Participating in a study like this means you might be among the first to try a new medicine that could potentially help with your cancer. However, as with any new treatment, there are also potential risks and side effects that we don't fully know yet, as the main purpose of this study is to understand them. The study team will closely monitor you and be there to support you. You are always in control of your participation and can decide to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

University of California San Francisco Helen Diller Comprehensive Cancer Center
Verified postcode
San Francisco, United States· Recruiting
Dana Farber Cancer Research Institute
Verified postcode
Boston, United States· Recruiting
University of Michigan Rogel Cancer Center
Verified postcode
Ann Arbor, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Sarah Cannon Research Institute
Verified postcode
Nashville, United States· Recruiting
MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
Centre Antoine Lacassagne
Verified postcode
Nice, France· Not yet recruiting
Institut de Cancerologie Gustave-Roussy
Verified postcode
Villejuif, France· Not yet recruiting

Common questions

What is Adenoid Cystic Carcinoma (ACC)?

ACC is a rare type of cancer that can grow in different parts of the body, often in the glands in the head and neck area.

What is REM-422?

REM-422 is a new experimental medicine being tested to see if it can help treat ACC by targeting specific signals within the cancer cells.

What does 'recurrent, metastatic, or unresectable' mean?

It means the cancer has come back after treatment, spread to other parts of the body, or cannot be completely removed by surgery.

Will I definitely get the new treatment?

Yes, everyone in this study will receive the experimental medicine REM-422.

How long will I be in the study?

You will stay in the study until your cancer gets worse, you experience side effects you can't tolerate, or you decide to leave the study.

How to find out more

Remix Therapeutics

clinicaltrials@remixtx.com 781-827-0902 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.