Active not recruitingPHASE1, PHASE2INTERVENTIONAL

MG1 Maraba/MAGE-A3, With and Without Adenovirus Vaccine With Transgenic MAGE-A3 Insertion in Incurable MAGE-A3-Expressing Solid Tumours

This research is exploring new ways to treat advanced cancers that have a specific marker called MAGE-A3. Doctors are using two types of viruses, MG1 Maraba/MAGE-A3 (MG1MA3) and Adenovirus/MAGE-A3 (AdMA3), which have shown promise in shrinking tumours in lab tests and animals. These viruses work by directly attacking cancer cells and by helping the body's immune system recognise and fight the cancer. Scientists want to understand if giving the AdMA3 virus first makes the treatment more effective. The main goal for the first part of the study is to find the safest and most effective dose of these viruses, used alone or together, for people with these cancers. It's not yet known if this new treatment will be better than existing standard treatments.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Canadian Cancer Trials Group

Enrolment target

Start

22 Jan 2015

Estimated completion

31 Dec 2026

Advanced/Metastatic Solid Tumours

What is this study about?

This research study is looking at new treatments for people with advanced solid tumours, which are cancers that have spread and can't be removed by surgery. Specifically, it's for tumours that have a particular marker called MAGE-A3. Researchers are testing two types of viruses, MG1 Maraba/MAGE-A3 and Adenovirus/MAGE-A3, that have been specially designed to target and destroy cancer cells. These viruses not only kill cancer cells directly but also aim to kickstart your body's own immune system to recognise and fight the cancer more effectively. The study is trying to understand if using these viruses, either alone or in combination, can help shrink tumours and improve cancer control.

The initial part of the study, called Phase 1, has a very important job: to carefully determine the safest and most effective dose of these new virus treatments. Researchers will start with very low doses and gradually increase them in small groups of patients, watching closely for any side effects. Their main priority is to make sure the treatment is as safe as possible while also being effective. If a dose causes serious side effects, they won't go higher.

Once a safe dose is found, the study moves into Phase 2. Here, more patients will receive the treatment at the determined safe dose, and the researchers will look more closely at how well the treatment works in shrinking tumours and improving patients' health. It's important to remember that these are brand new treatments, and it's not yet clear if they will offer better results than treatments currently available.

Key takeaways

This study is for advanced solid tumours with the MAGE-A3 marker.
It tests new virus-based treatments designed to kill cancer cells and boost your immune system.
The first part aims to find the safest and most effective dose of these viruses.
You will need to have tumour biopsies and regular check-ups.
Participation might offer access to a new treatment, but there are potential side effects.
You can withdraw from the study at any time.

Who may be eligible?

To be able to join this study, you generally need to be an adult, aged 18 or older. You should have a type of advanced cancer that has spread or can't be removed, and importantly, your tumour must show a specific marker called MAGE-A3. This marker will be checked in a sample of your tumour.

For the later part of the study (Phase 2), specific types of cancer are being looked at, including certain kinds of lung, breast, and oesophageal/stomach cancers. You should also generally be well enough to carry out most daily activities and have tried at least one other standard treatment for your advanced cancer already. The study will also require samples of your tumour, including a biopsy, to allow researchers to study the cancer closely.

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 type of advanced cancer that has spread or cannot be removed?
Has your doctor confirmed that your tumour has the MAGE-A3 marker?
Have you already tried at least one standard treatment for your advanced cancer?
Are you generally well enough to do most of your daily activities?
Are you able and willing to have tumour biopsies?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive one or both of the virus treatments. The doctors and nurses will watch you very closely, particularly when you first start the treatment, to check for any side effects. This monitoring will involve regular visits to the clinic, where you might have blood tests, scans (like CT scans) to check your tumour, and physical examinations. You will also need to have at least two tumour biopsies during the study. The total length of your participation will depend on how you respond to the treatment and the stage of the study, but it will involve ongoing follow-up appointments.

Potential risks and benefits

Participating in a clinical trial offers the chance to access a new treatment that isn't yet widely available, and it helps advance medical knowledge for others. While there's no guarantee this treatment will help your specific cancer, it might shrink your tumour or slow its growth. However, like all medical treatments, there are potential risks, and you might experience side effects from the viruses. The research team will explain all known and potential side effects in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

BCCA - Vancouver Cancer Centre
Verified postcode
Vancouver, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Verified postcode
Hamilton, Canada
Ottawa Hospital Research Institute
Verified postcode
Ottawa, Canada
University Health Network
Verified postcode
Toronto, Canada

Common questions

What is MAGE-A3?

MAGE-A3 is a specific marker that can be found on some cancer cells. This study is for tumours that have this particular marker.

What are these viruses and how do they work?

The study uses special viruses, MG1 Maraba/MAGE-A3 and Adenovirus/MAGE-A3, that are designed to find and kill cancer cells. They also aim to help your immune system fight the cancer.

Will this treatment cure my cancer?

This is a research study and it's not known whether these treatments will cure cancer. They aim to shrink tumours and help the body fight the disease, but more research is needed.

What are the main risks?

Like all treatments, there's a chance of side effects from the viruses. The doctors will monitor you closely and explain all the known and potential risks before you decide to join.

Can I leave the study at any time?

Yes, you are free to leave the study at any time, for any reason, without it affecting your usual medical care.