Active not recruitingPHASE1INTERVENTIONAL

A Dose Escalation and Expansion Trial With BYON4228 Alone and in Combination in Patients With Advanced or Metastatic Solid Tumors

This research study is looking at a new treatment called BYON4228, which is a type of antibody therapy. It's being tested for people who have advanced solid tumours (cancers that form solid lumps) that have either come back or spread, or for which standard treatments haven't worked. The study has two main parts. The first part is about carefully increasing the dose of BYON4228 to find the safest and most effective amount. The second part will then look at how well BYON4228 works when given alongside another cancer drug, pembrolizumab, in specific groups of patients. The main goals are to understand the safety of the treatment and see if it can help slow down or shrink the cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Byondis B.V.

Enrolment target

Start

07 May 2025

Estimated completion

01 Dec 2026

Solid Tumor

What is this study about?

This study is particularly for people with solid tumours that are advanced or have spread. These are cancers that form a solid mass, rather than blood cancers. You might be eligible if your current treatment hasn't worked, the cancer has progressed, or if there isn't a standard treatment option available for your type of cancer. The researchers want to investigate a new medication, BYON4228, which is designed to help your own immune system fight cancer cells. They are also looking at whether it works even better when given with another well-known cancer drug called pembrolizumab.

BYON4228 works by blocking a specific signal (called SIRPα) that cancer cells sometimes use to 'hide' from your immune system. By blocking this signal, BYON4228 aims to make it easier for your immune cells, like protective white blood cells (monocytes, macrophages, and neutrophils), to recognise and attack the cancer. Pembrolizumab, on the other hand, is another type of immune therapy that helps 'unleash' your immune cells to fight cancer.

The study has two main stages. The first part is about carefully finding the right dose of BYON4228 – starting with a small amount and gradually increasing it – to identify the dose that is both safe and has the best chance of working. Researchers call this the 'Maximum Tolerated Dose' or 'Recommended Dose for Expansion'. Once this dose is found, the second part of the study will involve more people and will focus on how well BYON4228 works in combination with pembrolizumab, as well as continuing to monitor for any side effects.

Key takeaways

This study tests a new immune-boosting drug, BYON4228, for advanced solid tumours.
It aims to find the safest and most effective dose, sometimes combined with pembrolizumab.
It's for people whose cancer has progressed or for whom standard treatments aren't available.
Participation involves regular clinic visits, tests, and receiving study medication.
Benefits are uncertain, and there's a risk of side effects; your health will be closely monitored.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you must have a solid tumour that is advanced or has spread, and your current treatments haven't been successful, or there isn't a standard treatment for your cancer type. You'll need to be generally well enough to take part, meaning you can carry out most everyday activities without much trouble.

For the second part of the study, where BYON4228 is given with pembrolizumab, your medical team will need to be able to measure your tumour(s) to see if the treatment is working. You'll also need to have healthy enough organs, like your liver and kidneys, to safely receive the study drugs.

There are also some reasons why you wouldn't be able to join. For example, if you've recently had other cancer treatments, specifically within the last four weeks; if you've had a bad reaction to similar drugs in the past; or if you have specific heart problems, a severe infection, certain autoimmune conditions, or untreated brain tumours. If you've been treated with pembrolizumab before and your cancer got worse quickly afterwards, you likely won't be able to join the later part of the study.

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.

Do you have an advanced or spreading solid tumour?
Have standard treatments either stopped working or are there no standard options for your cancer?
Are you generally well and able to do most daily activities?
Do you have healthy enough organ function (e.g., kidneys, liver)?
Have you avoided other cancer treatments for at least four weeks?
Do you have active brain tumours, severe infections, or serious heart problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive doses of the study drug, BYON4228, and possibly pembrolizumab, usually given through a drip into your vein. The exact number of visits, tests, and how long you'll be involved will depend on which part of the study you join and how your body responds to the treatment.

You will have regular check-ups, which include physical examinations, blood tests, and scans (like CT or MRI) to see how the treatment is affecting your body and your cancer. The study will continue for as long as the treatment is beneficial and you are tolerating it well. After you stop receiving the study drug, you'll still have follow-up visits or calls to monitor your health and any long-term effects.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from receiving a new treatment that isn't yet widely available and could potentially help fight your cancer. However, there's no guarantee that the treatment will work for you, and like all medications, BYON4228 and pembrolizumab can cause side effects. These could range from mild to severe. The study team will closely monitor you and tell you about any known risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

Institut Jules Bordet
Verified postcode
Brussels, Belgium
UZ Leuven
Verified postcode
Leuven, Belgium
CIOCC Hospital Universitario HM Sanchinarro
Verified postcode
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Verified postcode
Madrid, Spain
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom
The Royal Marsden
Verified postcode
Sutton, United Kingdom

Common questions

What is a 'solid tumour'?

A solid tumour is a type of cancer that forms a lump or mass of tissue, like breast cancer or bowel cancer, as opposed to blood cancers like leukaemia.

What is BYON4228?

BYON4228 is an experimental drug designed to help your body's immune system recognise and attack cancer cells more effectively.

What is 'advanced or metastatic cancer'?

This means your cancer has either grown quite large, spread locally, or has spread to other parts of your body. 'Metastatic' specifically means it has spread.

What is the purpose of 'dose escalation'?

It's the first part of the study where doctors carefully increase the drug dose step-by-step for different groups of patients to find the safest and most effective amount.

Will I get both BYON4228 and pembrolizumab?

In the later part of the study (Part 2), many participants will receive both drugs. In the very first part (Part 1), some might receive only BYON4228 to determine the initial safe dose.