Not yet recruitingPhase I/IIInterventional

A Phase I/IIa trial of NVG-222 in participants with solid tumours

This clinical trial is investigating a new cancer drug called NVG-222 for people with advanced solid tumours. NVG-222 is designed to help the body's own immune system find and destroy cancer cells by connecting immune cells (T cells) directly to cancer cells. It features a unique 'off-switch' to enhance safety by reducing potential side effects if they occur. The study has two main goals: first, to find the safest and most effective dose of NVG-222, and second, to observe its side effects and how it acts in the body. Researchers also want to see if NVG-222 can shrink or control cancer growth. This trial is for adults whose cancer is no longer responding to standard treatments or for whom standard treatments aren't suitable.

At a glance

Status

Not yet recruiting

Phase

Phase I/II

Sponsor

Cancer Research UK

Enrolment target

Start

31 Jan 2027

Estimated completion

31 Jan 2031

Solid tumours

What is this study about?

This clinical trial is exploring a new medicine called NVG-222 for people living with advanced solid tumours. A 'solid tumour' means a lump or mass of abnormal tissue, as opposed to blood cancers. The main idea behind NVG-222 is to harness your body's natural defences – your immune system – to fight the cancer. Specifically, it works by acting like a bridge, connecting your immune cells (called T cells) directly to the cancer cells. This helps your T cells recognise and attack the cancer more effectively.

NVG-222 is special because it's designed to attach to a protein called ROR1, which is often found in high amounts on certain cancer cells, and to another protein called CD3 on your immune T cells. By bringing these two together, NVG-222 aims to guide your immune system to the cancer. What's also innovative about NVG-222 is that it includes a safety 'off-switch'. This is designed to reduce the risk of serious side effects by turning the drug off if early signs of problems appear, making the treatment safer.

The trial has two main parts. The first part aims to find the best and safest dose of NVG-222. The second part, which will involve more people once the best dose is known, will look more closely at how effective the drug is against specific types of solid tumours. The overall goal is to understand how NVG-222 works in the body, what side effects it might have, and if it can help shrink or control cancer growth. This research is important for potentially offering new treatment options where current treatments are no longer effective.

Key takeaways

Tests a new immune-boosting drug, NVG-222, for advanced solid tumours.
NVG-222 helps your immune system target and destroy cancer cells.
Includes a safety 'off-switch' to reduce serious side effects.
Aims to find the safest dose and see if it can shrink or control cancer.
For adults whose cancer is no longer responding to standard treatments.

Who may be eligible?

This study is looking for adults aged 18 or older who have certain types of advanced solid tumours. Importantly, your cancer should either have stopped responding to standard treatments, or your doctor believes standard treatments aren't suitable for you, or you've decided not to have the standard treatments offered.

For you to be considered, your cancer cells are expected to have a specific protein called ROR1 on their surface. You also need to generally be well enough to take part, with a good level of physical activity. There are specific medical tests that your doctor will check to make sure it's safe for you to join the study.

However, some things might mean you can't take part. For example, if you've recently had other cancer treatments like chemotherapy or radiotherapy within a certain timeframe, or if you have specific serious health conditions that could make the trial unsafe 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.

Are you 18 years or older?
Do you have an advanced solid tumour that isn't responding to standard treatments, or where standard treatments aren't suitable?
Is your cancer type expected to have ROR1 proteins?
Are you generally well enough for a clinical trial?
Have you discussed your eligibility with your doctor?

Answer every question to see your result.

What does participation involve?

This study is divided into two phases. In Phase I, you'll start with a low dose of NVG-222. Initially, one person at a time will receive the drug, with the dose gradually increasing for the next person if no serious side effects occur. Later in Phase I, small groups of people will receive carefully chosen doses. This helps researchers find the safest and most effective dose.

Once the best dose is determined, Phase II will begin. In this phase, a larger group of participants with specific solid tumours will receive that established dose. Throughout the trial, you'll have regular hospital visits for assessments, including blood tests, scans, and physical examinations, to monitor your health, how the drug is affecting your body, and any potential side effects. The exact number of visits and the total duration in the study will depend on which phase you're in and how you respond to the treatment. You can withdraw from the study at any time.

Potential risks and benefits

NVG-222 is a new investigational drug, which means its full effects are still being understood. The potential benefits include the possibility that NVG-222 could shrink or control your cancer, especially if standard treatments haven't worked or aren't suitable. However, there's no guarantee of benefit. As with all medicines, there are potential risks and side effects, which the research team will explain in detail. The study has been carefully designed with built-in safety features, like the 'off-switch' in NVG-222, and you will be closely monitored by medical professionals throughout your participation to identify and manage any side effects. You have the right to withdraw from the study at any time for any reason.

Locations (1)

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

Guy's Hospital
Unverified
London, England

Common questions

What kind of cancer is this study for?

This study is for people with certain types of advanced solid tumours that have stopped responding to standard treatments or for which standard treatments aren't an option.

What does NVG-222 do?

NVG-222 is a new drug designed to help your body's immune system find and kill cancer cells more effectively by connecting immune cells directly to cancer cells.

Will I definitely get the drug if I join?

Yes, if you meet all the study requirements, you will receive NVG-222, starting with a carefully chosen dose in the trial's early phases.

How long will I be in the study?

The duration of your participation will depend on which phase of the study you are in and how you respond to the treatment. Your study doctor can provide more specific details.

Who is running and paying for this study?

This study is being run by Cancer Research UK and is funded by Cancer Research UK and NovalGen Ltd.

How to find out more

Stuart Smith

stuart.smith@cancer.org.uk +44 (0)20 34696878 Official trial record

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