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AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients with Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

This study is testing an experimental medicine called VRN110755 for people with non-small cell lung cancer that carries a specific genetic change, known as an EGFR mutation. Because this is an early-stage clinical trial, it is one of the first times this drug is being tested in humans. The trial has two main parts. In the first part, doctors will test different doses to find the safest amount that causes the fewest side effects. In the second part, researchers will see how well that dose works to shrink tumours or stop them from growing, including any cancer that may have spread to the brain. Participants will have regular health checks, blood tests, heart tracings, and hospital scans. The information gathered will help doctors find out whether VRN110755 could become an effective future treatment option.

At a glance

Status
Authorised
Phase
Phase I and Phase II (Integrated)- First administration to humans
Sponsor
Voronoi Inc.
Enrolment target
45
Start
19 Oct 2026

What is this study about?

Non-small cell lung cancer is the most common form of lung cancer. In some patients, the cancer cells have an abnormal protein on their surface called EGFR (epidermal growth factor receptor). This fault acts like an 'on' switch that tells cancer cells to grow and spread.

This trial is looking at an experimental targeted therapy called VRN110755. The medicine is designed to block this faulty switch and stop the cancer cells from multiplying. Because this is an early-phase trial, researchers need to find out how the human body processes the drug, what dose is best, and what side effects might occur.

Existing treatments for EGFR-mutant lung cancer can work well, but the cancer often learns to resist them over time. Developing new medicines is vital to give patients more options when standard therapies stop working. Researchers also want to see whether VRN110755 can reach and treat cancer that has spread to the brain, which is a frequent challenge in advanced lung cancer.

Key takeaways

  • Tests a new targeted medicine (VRN110755) for EGFR-mutant non-small cell lung cancer.
  • A Phase 1/2 trial to find the safest dose and see how well it controls tumours.
  • Examines how well the drug works in the lungs and in the brain.
  • Open to adults aged 18 and over with the required tumour mutation.
  • Involves regular hospital visits for scans, blood tests, and health monitoring.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with non-small cell lung cancer that has a confirmed EGFR mutation. Your cancer specialist can check your medical records or previous biopsy results to confirm if your tumour has this specific genetic change.

Participants need to be generally well enough to care for themselves and carry out day-to-day activities. Both men and women can take part.

To ensure participant safety, people with certain other severe health problems, significant heart conditions, or active infections may not be able to join. Your doctor can review your overall health to see if this study would be suitable for you.

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.

  1. You are aged 18 or older.
  2. You have been diagnosed with non-small cell lung cancer.
  3. Your cancer has been confirmed to have an EGFR mutation.
  4. You are well enough to carry out everyday activities.
  5. You can travel to the hospital for frequent visits, tests, and scans.
Answer every question to see your result.

What does participation involve?

If you take part, you will receive the study drug VRN110755 and be closely looked after by a specialist hospital team. You will have regular clinic visits that include physical checks, eye examinations, heart tests (ECGs), and blood tests. You will also have periodic CT or MRI scans to check whether your tumours are shrinking or staying stable. Blood samples will be taken to measure how much medicine stays in your bloodstream and to look for tiny traces of tumour DNA. Treatment usually continues for as long as your cancer remains stable and the side effects are manageable, followed by regular check-ups to see how you are doing.

Potential risks and benefits

A potential benefit is that the study drug may help shrink your tumours or stop them growing, and you will receive very close medical attention. However, because this is an early trial, there is no guarantee the drug will help you. There is also a risk of unexpected or unpleasant side effects. Taking part is entirely your choice, and you can withdraw from the study at any time without giving a reason and without affecting your normal NHS care.

Locations (3)

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

Common questions

What is an EGFR mutation?

It is an abnormal change in a specific gene inside cancer cells that produces a protein causing the cells to grow and divide too quickly.

Will I receive a dummy treatment (placebo)?

No. In this early-stage trial, all participants receive the active study drug, VRN110755.

What happens if I experience side effects?

The trial doctors will check you regularly. If you have side effects, they can give you treatments to relieve them, adjust your dose, or pause the study drug if necessary.

Does this trial treat cancer that has spread to the brain?

Yes, the study will specifically monitor how well the medicine works on tumours that have spread to the brain.

Can I leave the study if I change my mind?

Yes. You are free to stop taking part at any point, and your standard cancer care will continue as normal.

How to find out more

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

Discussion

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