RecruitingPhase IInterventional

The first-in-human trial of MDX-124 in patients with advanced cancer

This clinical trial is looking at a new cancer medicine called MDX-124. It is designed for adults with advanced solid tumours that cannot be removed by surgery or have spread to other areas, and where standard NHS treatments are no longer working. MDX-124 is a targeted therapy called a monoclonal antibody. It is designed to find and attach to a specific protein called annexin-A1. When cancer cells produce too much of this protein, it can help the cancer grow and spread. MDX-124 aims to block this protein and help the immune system fight the cancer. Because this is a Phase 1 study, it is the first time MDX-124 has been tested in people. The main goals are to find the safest dose, see how the body handles the drug, and check for side effects. Participants will receive the drug through a drip in hospital alongside regular health checks and scans.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Medannex Limited

Enrolment target

103

Start

01 Aug 2023

Estimated completion

30 Sep 2027

Locally advanced, unresectable or metastatic solid malignancies

What is this study about?

This trial is testing an experimental medicine known as MDX-124. It is a type of treatment called a humanised monoclonal antibody. Antibodies are natural proteins made by our immune system to fight off illness. In a laboratory, scientists can design targeted antibodies that attach to very specific proteins found on cancer cells. MDX-124 is designed to attach to a protein called annexin-A1 (or ANXA1). While this protein has normal roles in the body, some cancers produce far too much of it, which can help tumours grow, survive, and spread.

Because MDX-124 has never been given to people before, this Phase 1 trial is an important first step. When standard cancer treatments stop working, doctors look for new options. The main purpose of this study is not yet to prove how well the medicine cures cancer, but to understand its safety. Doctors need to find out the right dose to give, how the human body processes the medicine, and what kinds of side effects it might cause.

The trial is split into two main sections, called modules. The first module starts with small groups of patients receiving a low dose of the drug through a drip. If that dose is safe, the next group of patients receives a slightly higher dose until doctors find the best, most effective amount. The second module tests this chosen dose in larger groups of patients with specific types of cancer, such as pancreatic cancer, to see how the drug performs either by itself or alongside standard chemotherapy.

Taking part helps researchers gather vital clues about whether MDX-124 could become a valuable new treatment option in the future. The trial is being run by specialist cancer teams across UK hospitals to ensure participants receive close medical monitoring throughout.

Key takeaways

MDX-124 is an experimental targeted antibody being tested in humans for the first time.
The trial is open to adults with advanced solid tumours where standard treatments are no longer working.
The main goals are to check drug safety, understand side effects, and find the right dose.
The drug is given as an intravenous drip in a hospital clinic every two to three weeks.
Participants receive close health monitoring, including regular blood tests and CT scans.

Who may be eligible?

This trial is for adults aged 18 and over who have an advanced solid cancer that has spread or cannot be removed with surgery. It is aimed at people whose cancer is known to produce the ANXA1 protein—such as bowel, breast, lung, pancreatic, stomach, bladder, kidney, prostate, or ovarian cancer—and where standard treatments are no longer working or are not available.

To be considered, you must be well enough to carry out light daily activities and care for yourself. Your vital organs, including your liver, kidneys, and bone marrow, must also be working well enough to process the medication safely, which will be checked using routine blood tests.

You will not be able to take part if you are pregnant or breastfeeding. In addition, some specific cancers—such as head, neck, and cervical cancers—are not included in this study because lab tests show they do not respond to this type of treatment.

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.

I am aged 18 or over.
I have been diagnosed with an advanced solid cancer that cannot be removed by surgery or has spread.
My current or standard cancer treatments are no longer working, or there are no suitable standard options left.
I am able to look after myself and do light daily activities independently.
I am willing and able to attend regular hospital appointments for treatment, scans, and blood tests.

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive MDX-124 as an intravenous drip (into a vein) at a specialist hospital clinic. In the first part of the study, the drip is usually given once every two weeks, and later it may be given every three weeks. On your first treatment day, you will need to stay at the clinic for about six hours so the medical team can watch you closely for any immediate reactions.

You will have regular hospital visits for blood tests, physical checks, and CT scans. Scans are carried out roughly every eight to nine weeks to see how your tumour is responding. You will also have blood samples taken to measure how much medicine stays in your body. In some parts of the study, doctors may ask to take a small sample of your tumour tissue (a biopsy), though this is optional in the earliest phase.

You can stay on the trial treatment for as long as your cancer remains stable or improves, and as long as any side effects remain manageable. You are free to stop treatment at any time. The overall trial is scheduled to run until late 2028.

Potential risks and benefits

Taking part may or may not help shrink your tumour, but you will receive very close medical care and frequent monitoring from cancer specialists. Your participation will also help researchers understand whether this new drug can help future patients. However, because this is the first time MDX-124 is being given to humans, there is a risk of unexpected side effects, allergic reactions during the drip, and discomfort or bruising from frequent blood tests. Scans also involve a small amount of radiation. You are completely free to leave the trial at any point, and choosing to withdraw will never affect your standard NHS medical care or your relationship with your healthcare team.

Locations (6)

Clatterbridge Hospital
Approximate
Wirral, England
Edinburgh Cancer Research Centre
City only
Edinburgh, Scotland
Churchill Hospital
Approximate
Oxford, England
Beatson West of Scotland Cancer Centre
City only
Glasgow, Scotland
The Christie NHS Foundation Trust
City only
Manchester, England
Guys and St Thomas NHS Foundation Trust
Unverified
London, England

Common questions

Is MDX-124 a type of chemotherapy?

No. MDX-124 is a targeted antibody therapy. It is designed to attach to a specific protein linked to cancer growth, rather than attacking all fast-growing cells like traditional chemotherapy.

Will I receive a placebo (dummy drug)?

No. In this Phase 1 trial, there is no dummy treatment. Every participant who joins the study will receive the active study drug, MDX-124.

Do I have to pay to take part?

No. Clinical trials in the UK do not charge patients for the trial medication or the extra tests required by the study.

What happens if I experience unpleasant side effects?

Your study doctor will monitor you closely. If you develop difficult side effects, they can pause the treatment, lower the dose, give you medications to treat the symptoms, or stop the study drug altogether.

Can I leave the study if I change my mind?

Yes. Taking part is completely voluntary. You can withdraw from the study at any time without giving a reason, and it will not change the quality of your regular NHS care.

How to find out more

- Liverpool Clinical Trials Centre

attainment@liverpool.ac.uk +44(0)151 795 8751 Official trial record

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