RecruitingPhase IInterventional

NG-350A plus chemoradiotherapy for locally advanced rectal cancer

This study is for adults with locally advanced rectal cancer that hasn't spread far. Researchers are testing a new treatment called NG-350A, which is a gene therapy made from a virus. It's designed to help your immune system find and attack cancer cells. NG-350A will be given alongside standard chemotherapy and radiotherapy. The study will look at how effective this new combination is in shrinking the cancer and what side effects people might experience. About 30 patients will take part, with careful monitoring for safety. The goal is to see if this new approach can offer a better way to treat this type of cancer.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Akamis Bio Ltd.

Enrolment target

Start

15 Feb 2025

Estimated completion

30 Nov 2026

Medical condition: Histologically confirmed clinical stage II-III adenocarcinoma of the rectum with at least one pre-specified risk factor for recurrence

What is this study about?

Globally, cancer is a major health challenge, and doctors are always looking for new and better ways to treat it. This particular study focuses on locally advanced rectal cancer, which means the cancer has grown into nearby tissues but hasn't spread widely to other parts of the body.

The new treatment being tested is called NG-350A. It's a special type of medicine called gene therapy, which uses a modified virus. Don't worry, this virus is designed to only infect cancer cells, not healthy ones. Once inside the cancer cells, it forces them to produce another substance called an 'anti-CD40 antibody.' This antibody then acts like a signal, waking up your body's immune system and directing it to attack the cancer cells. The idea is that NG-350A can both directly kill cancer cells and help your own body's defences fight the disease.

This study is in its early stages (Phase I), meaning it's primarily looking at the safety of NG-350A when combined with standard chemotherapy and radiotherapy, and if it shows early signs of working. The researchers want to understand how well the combination shrinks the cancer and what kind of side effects people might experience. Your participation could help us learn if this new approach might be a promising future treatment for rectal cancer.

Key takeaways

New study for locally advanced rectal cancer.
Tests NG-350A, a gene therapy to boost your immune system.
NG-350A given with standard chemotherapy and radiotherapy.
Focus on safety and how well it shrinks cancer.
Involves regular check-ups, blood tests, and scans.
Participation will be for up to three years.

Who may be eligible?

This study is open to adults aged 18 or over who have been diagnosed with rectal cancer that is considered 'locally advanced.' This means the cancer is in your rectum and may have grown into nearby tissues, but it hasn't spread far away. Your care team will have decided that you are suitable for standard chemotherapy and radiotherapy to treat your cancer.

To join, your cancer also needs to have at least one specific feature that increases the chance of it returning. This might include how close the tumour is to the edge of the tissue that would be removed in surgery (called a 'circumferential resection margin'), whether certain lymph nodes are affected, or other specific characteristics of your tumour that your doctor would explain.

There are also some general health requirements, and you'll need to be willing to attend all scheduled study appointments and follow the study instructions. Those who are pregnant, planning to become pregnant, or breastfeeding cannot take part.

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 old or older?
Do you have locally advanced rectal cancer (diagnosed as Stage II or III)?
Have your doctors said you are suitable for standard chemotherapy and radiotherapy?
Does your cancer have specific features that mean it has a higher chance of coming back (your doctor can tell you if this applies)?
Are you able to attend all planned hospital visits and appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the new treatment, NG-350A, along with the standard chemotherapy and radiotherapy that your doctor would normally recommend. The active treatment period with NG-350A is planned for 12 weeks. During this time, you will have various check-ups, including routine blood tests, and scans like CT or MRI, and some small tissue samples (biopsies) will be taken. These are common procedures that are often part of standard cancer care.

After the initial 12 weeks, you will continue to have follow-up visits, which may sometimes be done over the phone, for at least one year and up to three years. These follow-up visits are important so that the study team can keep a close eye on your health, how you're responding to treatment, and any longer-term effects. The total time you'd be involved in the study, from start to finish, could be up to three years.

Potential risks and benefits

This early-stage study doesn't list specific benefits of taking part, as its main purpose is to test the safety and early effects of the new treatment. However, some patients may find comfort in receiving close medical attention. As with all medical treatments, there are potential risks and side effects. Possible serious side effects with NG-350A could include kidney problems, breathing difficulties, gut blockages, changes in blood clotting tests, and a condition called cytokine release syndrome, which your doctor will explain. Your study team has plans in place to reduce these risks, such as careful monitoring and adjusting doses if needed. You will have a detailed conversation with your doctor about all known and potential risks listed in the Participant Information Sheet before you decide to join. Remember, taking part in any study is entirely your choice, and you are free to withdraw at any time without affecting your usual medical care.

Locations (2)

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

University College London Hospitals NHS Foundation Trust
City only
London, England
The Royal Marsden NHS Foundation Trust
City only
London, England

Common questions

What is NG-350A?

NG-350A is a new, experimental gene therapy. It uses a modified virus to deliver instructions to cancer cells, making them produce a substance that helps your immune system fight the cancer.

What kind of cancer is this study for?

This study is for people with locally advanced rectal cancer, meaning the cancer has grown into nearby tissues but hasn't spread widely through the body.

Will I still get my usual cancer treatments?

Yes, NG-350A will be given alongside standard chemotherapy and radiotherapy, which are common treatments for this type of cancer.

How long will I be in the study?

You'll have an active treatment period of about 12 weeks, and then follow-up appointments for at least one year and up to three years, to monitor your health.

What are the main things the doctors are looking for?

The study aims to see how safe NG-350A is, what side effects it might cause, and if it helps to shrink the cancer when combined with standard treatments.

How to find out more

Robert Maietta

Robert.maietta@akamisbio.com - Official trial record

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