RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma

This study is looking into a new gene therapy called TGX-007 for adults aged 18-70 with glioblastoma, a type of aggressive brain tumour. The study has two main goals: first, to find the safest and most effective dose of TGX-007, and then to see how well it works in treating patients. TGX-007 uses a harmless virus to deliver two special components directly to the tumour. One component, when combined with the antiviral medicine valaciclovir, helps kill cancer cells. The other component boosts the body's own immune system to recognise and fight the tumour. Patients will receive TGX-007 as an injection into the tumour, followed by valaciclovir tablets. They will then have standard surgery and other treatments. The study welcomes patients who have been newly diagnosed or whose glioblastoma has returned.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Trogenix ltd

Enrolment target

Start

21 Apr 2026

Estimated completion

01 Sep 2033

Glioblastoma (GBM)High Grade Gliomas Recurrent Glioblastoma Newly Diagnosed Glioblastoma

What is this study about?

This study is investigating a new treatment called TGX-007 for a serious type of brain tumour called glioblastoma. Glioblastoma can be very aggressive, and doctors are always looking for new ways to treat it. TGX-007 is a 'gene therapy,' which means it involves introducing new genetic material into the body's cells to help fight the disease. In this case, a harmless virus is used like a delivery truck to carry two special substances directly into the tumour.

One of these substances, when combined with a common antiviral medicine called valaciclovir (which is usually used to treat cold sores), helps to directly kill the tumour cells. The other substance works by boosting your body's immune system, which is its natural defence, to recognise and attack the cancer cells more effectively. The aim is to make the tumour more vulnerable and help your body fight it from within.

The study is being carried out in two main stages. The first stage (Phase I) will involve carefully testing different doses of TGX-007 to find the safest and most effective amount. Once this 'optimal' dose is identified, the study will move to the second stage (Phase II). In Phase II, more patients will receive this optimal dose to find out how well TGX-007 works in treating both newly diagnosed glioblastoma and glioblastoma that has returned.

Key takeaways

This study is testing a new gene therapy, TGX-007, for glioblastoma.
It aims to find a safe dose and see how well TGX-007 helps kill tumour cells and boost the immune system.
TGX-007 works with everyday antiviral medicine, valaciclovir.
Patients receive an injection into the tumour, followed by valaciclovir tablets, then standard surgery and treatments.
The study includes newly diagnosed patients and those whose glioblastoma has returned.
Participation involves regular check-ups, blood tests, and scans.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 70 years old. Your general health, including your ability to perform daily activities, should be good (doctors use something called a 'Karnofsky performance status' to measure this, and you would need a score of 70 or higher).

If you have been newly diagnosed with glioblastoma, your tumour should be in one place and on one side of the brain, as seen on an MRI scan. Your medical team should also believe that standard surgery and chemotherapy/radiotherapy are suitable for you. If your glioblastoma has come back after previous treatment, this should be the first time it has returned, and your medical team should feel that further surgery is an option for you. Importantly, you should have a confirmed diagnosis of glioblastoma from earlier tests, be able to take medicines by mouth, and be willing to avoid certain types of vaccines.

There are also reasons why you might not be able to join. These include if you are pregnant, breastfeeding, or planning to become pregnant during the study. You also wouldn't be able to join if you have certain immune system problems, active infections, or have recently had certain types of surgery or gene therapy. Also, if you have a known allergy to valaciclovir or any of the study drugs, or if an MRI scan with contrast dye (gadolinium) is not suitable for you, you would not be able to participate.

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 between 18 and 70 years old?
Is your general health good enough for daily activities?
Have you been newly diagnosed with a single glioblastoma, or has your glioblastoma returned for the first time?
Are you able to take medicines by mouth (swallow tablets)?
Are you not pregnant, breastfeeding, or planning to become pregnant?
Do you have a confirmed diagnosis of glioblastoma?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the first step involves receiving a special injection of the study drug, TGX-007, directly into your brain tumour. This is done during a surgical procedure. After this, you will need to take valaciclovir tablets by mouth every day for up to 21 days. Following this period, you will have your standard surgery to remove as much of the tumour as possible, and you will then continue with your usual chemotherapy and radiotherapy treatments as prescribed by your doctors. Throughout the study, you will have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. The exact number and frequency of visits will be explained to you in detail. The total duration of your participation in the study will depend on how you respond to the treatment and the study's follow-up schedule.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of joining this study is that you might be among the first to receive a new treatment that could help fight your glioblastoma. However, it's also possible that TGX-007 may not work for you, or it might not work better than existing treatments. As with any medical procedure, there are potential risks and side effects associated with the injection, the study drug TGX-007, and the valaciclovir tablets. These will be fully explained to you before you decide to take part. Your health and safety are the top priority. You will have full support from the medical team, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ohio State University Hospital
Verified postcode
Columbus, United States· Not yet recruiting
Royal Infirmary of Edinburgh
Verified postcode
Edinburgh, United Kingdom· Recruiting

Common questions

What is glioblastoma?

Glioblastoma is a fast-growing and aggressive type of cancer that starts in the brain.

What is gene therapy?

Gene therapy uses genetic material to treat diseases. In this study, a harmless virus delivers substances into the tumour to help fight the cancer.

What is Valaciclovir?

Valaciclovir is a commonly used antiviral medicine, normally prescribed for cold sores. In this study, it works with TGX-007 to kill cancer cells.

How is TGX-007 given?

TGX-007 is given as an injection directly into the brain tumour during a surgical procedure.

Will I still have my regular treatments?

Yes, after receiving the study drug, you will proceed with standard surgery, chemotherapy, and radiotherapy as planned by your medical team.

How to find out more

Project Management

contact@trogenix.com +44131 287 5960 Official trial record

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