RecruitingPHASE1, PHASE2INTERVENTIONAL

Ixovex-1 Single Agent and Combination Therapy

This study is investigating a new treatment called Ixovex-1, which is a type of virus designed to fight cancer cells, for people with advanced solid tumours, including head and neck cancers. Researchers want to find out if Ixovex-1 is safe and how well it works, both on its own and when given with another cancer drug called Pembrolizumab. This trial is for patients whose cancer has either advanced locally, cannot be removed by surgery, or has spread to other parts of the body, and for whom standard treatments are no longer effective, unavailable, or have been declined. Two phases involve a small number of patients to find the best and safest dose of Ixovex-1. A later phase will look more closely at how well the combination treatment works in specific types of cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Psivac Ltd

Enrolment target

Start

17 Dec 2024

Estimated completion

30 Jan 2027

Solid Tumor Head and Neck Cancer

What is this study about?

This study is looking into a new way to treat certain advanced cancers, including solid tumours and head and neck cancers. The treatment involves a special virus, called Ixovex-1, which is designed to target and destroy cancer cells. This virus is injected directly into visible tumours.

The trial is divided into different stages. Initially, a small group of patients will receive Ixovex-1 on its own to help researchers find the safest dose and see how the body reacts to it. After that, another small group will get Ixovex-1 along with an existing cancer drug called Pembrolizumab, which helps the body's immune system fight cancer. This stage aims to determine the best dose of the combination treatment.

Finally, a larger group of patients will receive the combination treatment to further assess its effectiveness and safety in different types of advanced solid and head and neck cancers, especially for those who haven't responded well to previous treatments.

Key takeaways

This study is testing a new virus treatment (Ixovex-1) for advanced cancers.
It aims to find safe doses, both alone and with another drug (Pembrolizumab).
It's for patients with advanced solid tumours and head/neck cancer who have limited other options.
The treatment involves injections directly into visible tumours.
Participation involves regular hospital visits and close monitoring.
It's a research study; benefits aren't guaranteed, and there are potential side effects.

Who may be eligible?

This study is for adults aged 18 or over who have certain types of advanced solid tumours, including head and neck cancer. Your cancer must be either locally advanced (meaning it hasn't spread far but isn't easily treatable), cannot be removed by surgery, or has spread to other parts of the body.

Critically, you must have run out of standard treatment options, or these options are not suitable or have been declined. You also need to have at least one tumour that can be directly injected, and your general health, as assessed by blood tests and a performance status score, needs to be good enough 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 18 years of age or older?
Do you have advanced solid tumours or head and neck cancer?
Do you have a tumour that can be directly injected?
Have standard treatments either stopped working, are unavailable, or unsuitable for you?
Are you generally well enough to participate in a clinical trial?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you take part, you'll first sign a consent form and understand all aspects of the study. Initially, if you're in an early phase, you'll receive Ixovex-1 injections into your tumour about every two weeks, for a total of four treatments over eight weeks. If you're in a later phase for the combination therapy, you'll receive four doses of Ixovex-1 and eight doses of Pembrolizumab. Two Ixovex-1 doses will be given before Pembrolizumab starts, and two alongside the first two Pembrolizumab doses. The final six Pembrolizumab doses will be given on their own every three weeks. Throughout the study, you'll have regular hospital visits for assessments, blood tests, and to monitor your health and the treatment's effects. The total duration of your active treatment and follow-up will depend on the phase and your response.

Potential risks and benefits

While we hope this treatment may offer some benefit, it's important to remember that this is a research study, and there's no guarantee of improvement for your cancer. Potential benefits include access to a new experimental treatment not yet widely available. As with any medical treatment, there are potential risks and side effects, which the medical team will discuss thoroughly with you. You will be closely monitored for any reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

The Royal Marsden
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Ixovex-1?

Ixovex-1 is a special virus designed to attack and destroy cancer cells. It's injected directly into the tumour.

What is Pembrolizumab?

Pembrolizumab is a different type of cancer drug that helps your body's own immune system fight cancer cells.

Who can join this study?

Adults over 18 with advanced solid tumours or head and neck cancer who have limited other treatment options may be eligible.

Will I get Ixovex-1 alone or with Pembrolizumab?

Depending on which part of the study you join, you might receive Ixovex-1 by itself or in combination with Pembrolizumab.

What if currently approved treatments are still available for me?

This study is generally for patients who have already tried existing treatments, or for whom those treatments are not suitable or available.

How to find out more

Imad Mardini

i.mardini@psivac.com +44 20 7971 1100 Official trial record

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