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AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

PANVIRAL: Safety, Feasibility and Immunogenicity of Intra-Tumoral ORCA-010 Oncolytic Virus Administration in Metastatic Pancreatic Cancer – A Single-Center Phase 1 Trial

The PANVIRAL trial is looking at a new experimental treatment for people with advanced pancreatic cancer that has spread to other parts of the body. The study tests a specially altered virus called ORCA-010. This type of treatment is known as an oncolytic virus. Doctors inject the virus straight into the tumour. The virus is designed to multiply inside cancer cells, break them open, and help the body's immune system fight the cancer, while leaving healthy cells alone. Because this is an early Phase 1 study, the main goal is not to prove that the drug cures cancer, but to check whether it is safe, what side effects it causes, and how well the immune system reacts. It also tests how practical it is for doctors to deliver the virus directly into the tumour in a hospital setting.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Amsterdam UMC Stichting
Enrolment target
15
Start
09 Oct 2026

What is this study about?

Pancreatic cancer can be difficult to treat, especially when it has spread (metastasised) to other areas of the body. Current treatments like chemotherapy can help control the disease, but researchers are searching for new, more targeted ways to attack cancer cells and support the immune system.

The PANVIRAL trial explores an innovative approach using a modified virus called ORCA-010. In nature, viruses infect cells and multiply. Scientists have redesigned this particular virus so that it selectively targets and infects cancer cells. When the virus multiplies inside the tumour cells, it causes them to burst and die. This process also releases tumour markers, which can alert the body's natural immune defences to attack remaining cancer cells.

In this trial, the virus is injected directly into the pancreatic tumour using specialised hospital equipment. This direct injection aims to deliver the treatment right where it is needed most, while reducing effects on the rest of the body.

Because this is an early Phase 1 trial, doctors are primarily checking safety. They want to find out what side effects occur, confirm the best way to administer the injection, and see how the patient's immune system responds. While it is an experimental treatment, the results will help researchers decide if ORCA-010 should be tested in larger clinical trials in the future.

Key takeaways

  • PANVIRAL is an early Phase 1 trial testing an experimental virus therapy called ORCA-010.
  • The treatment is for adults with pancreatic cancer that has spread to other areas.
  • The virus is injected directly into the tumour to destroy cancer cells and stimulate the immune system.
  • The main aim of the study is to evaluate safety, side effects, and immune responses.
  • Participation is completely voluntary, and you can withdraw at any point.

Who may be eligible?

This trial is designed for adults aged 18 and over who have been diagnosed with advanced pancreatic cancer that has spread to other parts of the body (metastatic cancer).

To be considered, patients must be well enough in their day-to-day life to undergo the injection procedure and attend regular hospital visits. The tumour must also be in a position where doctors can safely reach it with a needle to inject the virus.

People may not be able to join if they have certain other severe medical conditions, active uncontrolled infections, or a severely weakened immune system that makes virus-based treatments unsafe. A doctor will review your full medical history and current scans to check whether you qualify.

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. I am aged 18 or older.
  2. I have been diagnosed with pancreatic cancer that has spread (metastatic).
  3. I am well enough to carry out daily activities and attend hospital visits.
  4. I am open to receiving an injection directly into my tumour.
  5. I do not have severe active infections or an uncontrolled immune disorder.
Answer every question to see your result.

What does participation involve?

Taking part in this study involves several stages at a specialised hospital. First, you will have screening tests, including blood tests, physical checks, and imaging scans (such as CT or MRI scans) to confirm the trial is suitable for you. During the treatment stage, a specialist doctor will inject the ORCA-010 virus directly into your pancreatic tumour, usually guided by ultrasound or CT imaging. You may need to stay in the hospital for observation immediately after the procedure. Afterwards, you will attend regular follow-up appointments over several weeks or months so the medical team can monitor your health, check for side effects, collect blood samples to study your immune response, and perform routine scans. The study team will provide an exact schedule of visits before you decide to take part.

Potential risks and benefits

Because ORCA-010 is an early-stage treatment, there is no guarantee that it will shrink your tumour or improve your condition, though researchers hope it will trigger a helpful immune response. The treatment carries potential risks, including pain, bleeding, or bruising where the injection is given. You may also experience temporary flu-like symptoms, such as fever, chills, tiredness, or nausea, as your body reacts to the virus. There is also a risk of unexpected side effects. Joining the trial is entirely voluntary. You can choose to leave the study at any time, for any reason, and your regular NHS medical care will continue as normal.

Locations (1)

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

Common questions

What is an oncolytic virus?

It is a virus that has been modified in a laboratory to infect and destroy cancer cells without harming normal, healthy cells.

Can the virus give me a normal viral illness?

The virus is modified so it cannot cause ordinary illnesses, but it may cause short-term flu-like symptoms, such as a mild fever or aches, as your immune system reacts to it.

Is this trial guaranteed to cure my cancer?

No. This is a Phase 1 safety trial, meaning doctors are testing whether the treatment is safe and practical, rather than proving it is a cure.

How is the treatment given?

A doctor uses medical imaging (such as an ultrasound or CT scan) to guide a needle and inject the virus directly into the tumour.

What happens if I change my mind after joining?

You are free to stop participating at any time. Leaving the trial will not affect the quality of your ongoing cancer care or your relationship with your doctors.

How to find out more

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

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