First study evaluating the safety and dosage of YG-01 in patients with a malignant brain tumor
Glioblastoma is an aggressive type of brain tumour that can be difficult to treat, making new therapies urgently needed. This study is testing an experimental medicine called YG-01. Because this is a 'Phase 1' study, it is the first time the medicine is being tested in humans. The main aim is to check how safe YG-01 is and how the human body processes it. Doctors will test different amounts of the drug to work out the safest and most effective dose for future research. They will also look for any early signs that the treatment might help slow down tumour growth. The trial is open to men and women aged 18 and older who have a diagnosis of glioblastoma. Taking part involves visiting a hospital clinic regularly for health checks, blood tests, brain scans, and careful monitoring by a specialist team.
At a glance
What is this study about?
Glioblastoma is a serious, fast-growing type of brain cancer. Current treatments usually involve surgery, radiotherapy, and chemotherapy. However, because these tumours often return, researchers around the world are looking for new and better ways to target cancer cells in the brain.
This trial is testing an experimental drug called YG-01. It is a 'Phase 1' trial, which means it is the first time doctors are giving YG-01 to human volunteers. In laboratory tests, the drug showed promise, but scientists now need to see how it works in real patients.
Because safety is the top priority, only a small number of people will join the trial at first. Doctors will start with a low dose of YG-01. If it proves safe, slightly higher doses may be given to new groups of patients. This helps researchers discover the ideal dose that gives the best chance of helping without causing harmful side effects.
Although it is too early to know if YG-01 will cure or shrink brain tumours, the information gathered from this study is vital. It lays the groundwork for larger clinical trials in the future and could lead to new treatment options for people living with glioblastoma.
Key takeaways
- Tests a new experimental medicine called YG-01 for adults with glioblastoma.
- This is a Phase 1 study, meaning it is the first time the drug is being given to humans.
- The primary aim is to test safety, find the best dosage, and track side effects.
- Participants will receive regular hospital checks, blood tests, and brain scans.
- Taking part is voluntary, and you can stop at any time without losing your regular care.
Who may be eligible?
This study is designed for adults aged 18 and over who have been diagnosed with glioblastoma, an aggressive form of brain cancer. Both men and women can take part.
Because this is an early-stage safety trial, participants must generally be well enough to travel to hospital visits and carry out daily tasks. Doctors will check your medical history, kidney and liver function, and blood cell counts to ensure your body can safely handle the new medicine.
You may not be able to join if you have certain other serious medical conditions, such as uncontrolled heart disease or active infections, or if you are pregnant or breastfeeding. The trial doctors will discuss your full medical history with you to see if the study is a safe choice.
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.
- I am aged 18 or older.
- I have been diagnosed with glioblastoma (a malignant brain tumour).
- I am well enough to attend frequent hospital visits and undergo scans.
- I am willing to follow the trial schedule and report any symptoms to the study team.
- I understand this is an early-stage safety study testing a drug in humans for the first time.
What does participation involve?
Taking part in this study involves receiving the study drug YG-01 and attending regular appointments at a specialist hospital clinic. Before starting, you will have baseline tests, which usually include physical exams, blood tests, heart traces (ECGs), and magnetic resonance imaging (MRI) scans of your brain. During treatment, the medical team will give you YG-01 and monitor you very closely for any side effects or changes in your health. You will have ongoing blood tests and routine brain scans to see how your body and tumour are responding. The total duration of the study depends on how well you tolerate the drug and whether it seems to be helping, and you will also have follow-up visits after treatment ends so the team can check on your long-term wellbeing.
Potential risks and benefits
Locations (1)
- —UnverifiedAustria
Common questions
What is a Phase 1 clinical trial?
A Phase 1 trial is the earliest stage of testing a new medicine in people. Its main goal is to check safety, find the right dose, and monitor any side effects.
How is YG-01 given?
The trial team will explain whether YG-01 is given as a tablet to swallow or as a liquid drip into a vein (an infusion), along with how often you will need it.
Do I have to pay to take part?
No, clinical trial medicines and study-related tests are provided free of charge. Some trials also help cover travel expenses to and from the hospital.
Can I leave the study if I change my mind?
Yes, taking part is completely voluntary. You have the right to withdraw from the trial at any point, and your usual medical team will continue to care for you.
Will this drug cure my brain tumour?
Because YG-01 is still experimental, doctors do not yet know if it can shrink or cure glioblastoma. The study is mainly designed to find out if the drug is safe.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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