AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A study to investigate how a single dose of the drug melflufen reaches brain tumor tissue, and how it affects the tumour, in patients who are already scheduled for surgery for a returning glioblastoma

This research study is for people in the UK aged 18 or over who have glioblastoma, a type of brain tumour, that has returned after previous treatment. Participants will receive a single dose of a drug called melflufen shortly before they have surgery to remove their tumour. The main aim is to understand how well melflufen reaches the tumour tissue in the brain and how it affects the tumour cells. This early-stage study is an important step in learning more about this potential treatment and whether it could be helpful for patients with recurrent glioblastoma in the future.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Oncopeptides AB

Enrolment target

Start

15 May 2026

Recurrent glioblastoma

What is this study about?

This study is about a new drug called melflufen. Doctors want to find out how this drug works in people who have a type of brain tumour called glioblastoma, which has grown back after being treated before. When you have glioblastoma, cells in your brain grow in a way they shouldn't.

In this study, doctors are giving a single dose of melflufen to patients who are already going to have surgery to remove their tumour. Then, during the surgery, they will carefully look at the tumour tissue to see if the drug has reached it and what effects it might be having. This helps them understand how the drug behaves in the body and if it's getting to the right place.

Finding out how a drug behaves inside the body, especially in a brain tumour, is a very important first step. This kind of early research tells us if a new treatment might be worth studying further. It helps scientists understand if melflufen could potentially become a helpful medicine for people with recurrent glioblastoma in the future.

Key takeaways

This study is for adults with glioblastoma that has returned.
It tests a drug called melflufen before planned surgery.
Doctors want to see how the drug affects the tumour.
It's an early research step to understand a new potential treatment.
Participation helps future patients with glioblastoma.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. You would be considered for this study if you have glioblastoma that has grown back, even after you've had treatment for it before.

Before you can join, doctors will need to check your medical history to make sure the study is right for you and that you meet certain health requirements. It's important that you are already planning to have surgery to remove your glioblastoma tumour as part of your normal treatment.

If you're unsure whether you might be eligible, the best thing to do is talk to your main doctor or the research team who are running the study. They can look at your specific health situation and tell you if you could take part.

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 that has come back?
Are you already scheduled for surgery to remove your glioblastoma?
Are you able to attend study appointments as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of the study drug, melflufen, a short time before your planned brain surgery. This drug would be given to you by a healthcare professional. During your surgery, the doctors will collect a small sample of your tumour tissue as they normally would, but they will also analyse it to see how the study drug has affected it.

There will be appointments before the drug is given to check your health and suitability for the study. After your surgery, there will be some follow-up appointments to monitor your recovery and check for any side effects. The exact number and timing of visits will be explained to you in detail by the study team, but the main intervention is the single dose of the drug before your scheduled surgery.

Potential risks and benefits

Taking part in early studies like this helps doctors learn more about new drugs, which could benefit future patients. While there's no guarantee the drug will directly help you, your participation provides valuable information. All medications have potential side effects, and while melflufen may cause some, the study team will monitor you closely. 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
Norway

Common questions

What is glioblastoma?

Glioblastoma is a serious type of cancer that starts in the brain.

What does 'recurrent' mean?

It means the glioblastoma has come back after it was treated before.

What is melflufen?

Melflufen is the name of the new drug being tested in this study.

Will I still have my surgery if I join?

Yes, you will still have your planned surgery. The drug is given shortly before it.

Is this a cure for glioblastoma?

This is an early study to learn more about the drug; it's not known yet if it's a cure.