RecruitingPHASE1, PHASE2INTERVENTIONAL

A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer

This study is looking at a new drug called UCB4594 for people with certain advanced cancers. It’s the very first time this drug is being given to humans. UCB4594 is designed to help your immune system fight cancer by targeting a specific protein found on cancer cells. Researchers want to find out the best, safest dose and understand any side effects. They also want to see how the drug works in the body and if it can shrink tumours. The study will gradually increase the dose to find the right amount, and then test it alone or with other cancer treatments to see how effective it is.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Cancer Research UK

Enrolment target

167

Start

09 Jul 2024

Estimated completion

01 Nov 2029

Advanced Solid Tumours Squamous Cell Carcinoma of Head and Neck Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Triple Negative Breast Neoplasms Carcinoma, Renal Cell (Clear Cell Only)Esophageal Neoplasms Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors)Uterine Cervical Neoplasms Ovarian Neoplasms Pancreatic Neoplasms

What is this study about?

This clinical trial is investigating a new drug called UCB4594. It's important to know that this is the first time this drug has ever been tested in people, so we are learning as we go. UCB4594 is a special type of medicine called a 'monoclonal antibody'. Think of it like a smart bomb that's designed to find and attach to a specific target on cancer cells. In this case, the target is a protein called human leucocyte antigen G (HLA-G).

Many cancer cells have a lot of this HLA-G protein. By attaching to it, UCB4594 hopes to make it easier for your body's own immune system to spot and attack these cancer cells. The main goals of this study are to find the best and safest dose of UCB4594, understand any side effects it might have, and see what happens to the drug inside your body. We also want to find out if it can cause tumours to shrink.

The study has two main parts. The first part involves giving small groups of people very low doses of UCB4594, gradually increasing the dose for new groups, to find the safest and most effective amount. Once that 'best' dose is found, the second part will look at giving UCB4594 alone or with other cancer medicines to see exactly how it works and whether it helps to shrink tumours.

Key takeaways

This is the first time this new drug, UCB4594, is being tested in humans.
UCB4594 aims to help your body's immune system fight cancer.
The study wants to find the safest dose and see if it can shrink tumours.
Participation involves strict monitoring and regular check-ups.
You can stop participating at any time if you wish.
This is an early-stage trial, so long-term effects are not yet known.

Who may be eligible?

This study is for adults aged 18 or older who have certain types of advanced cancer. These are cancers that haven't responded well to usual treatments, or where standard treatments aren't suitable. The specific cancers being looked at include advanced solid tumours such as head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, kidney cancer (clear cell type), oesophageal or stomach cancer (not including a specific type called GIST), cervical cancer, ovarian cancer, and pancreatic cancer.

To join, your cancer needs to be clearly measurable, and you should be generally well enough to take part, with a life expectancy of at least 12 weeks. Your blood tests and overall health will need to be within certain limits. You'll also need to have a recent biopsy (a small sample of tissue taken from the tumour) and be able to provide another one if asked.

There are also reasons why people cannot join the study. These are often related to other ongoing medical conditions, certain past treatments like recent radiotherapy (unless it was for pain relief), or if your cancer is a specific rare type. Your medical team will carefully check all these details with you to see if this study could be a good fit.

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 one of the advanced solid cancers mentioned (e.g., advanced lung, bowel, breast (triple-negative), stomach, or kidney cancer)?
Has your cancer not responded to standard treatments, or are those treatments not suitable for you?
Are you generally well enough to take part and expect to live for at least 12 weeks?
Are you able to have a recent tumour biopsy, and potentially another during the study?
Are you comfortable with frequent hospital visits and close monitoring?

Answer every question to see your result.

What does participation involve?

If you choose to take part, you'll be monitored very closely throughout the study. UCB4594 is a new drug for humans, so the research team will keep a close eye on your health. The study involves regular visits for check-ups, blood tests, and scans to see how you're responding and to monitor for any side effects. The medication, UCB4594, will be given to you by the study team. They will explain exactly how it's administered. The total duration of your participation will depend on how you respond to the treatment and the stage of the trial you are in, but the team will discuss this in detail with you before you agree to join.

Potential risks and benefits

Since UCB4594 is a new drug, its effects in humans are not yet known. Based on lab tests and similar drugs, possible benefits might include helping your immune system fight your cancer, potentially leading to tumour shrinkage. However, there are also potential risks, such as side effects, which the medical team will explain. Like with any new medicine, we cannot predict all possible effects. Your health will be carefully monitored, and you will have regular check-ups. Remember, participation is completely voluntary, and you are free to withdraw from the study at any time without giving a reason, and it won't affect your usual medical care.

Locations (4)

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

Guy's Hopsital
Verified postcode
London, United Kingdom· Recruiting
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Verified postcode
Newcastle upon Tyne, United Kingdom· Recruiting
University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom· Not yet recruiting

Common questions

What is UCB4594?

It's a new experimental drug, a type of 'monoclonal antibody', designed to help your immune system fight certain cancers by targeting a protein on cancer cells.

Why is this study being done?

Because UCB4594 is new, researchers need to find the safest dose for people, understand its side effects, and see if it can help shrink tumours.

Are there different parts to the study?

Yes, there are two main parts. The first part finds the best dose, and the second part tests that dose alone or with other medicines to see how it works and whether it can shrink cancer.

Will I get 'the drug' or a 'dummy' treatment?

In this specific trial, all participants will receive UCB4594. There is no 'dummy' treatment (placebo) involved.

What if I feel unwell during the study?

The study team will monitor you very closely. You should always tell them immediately if you feel unwell or experience any new symptoms.

How to find out more

Fiona Thistlethwaite, Prof

the-christie.ecmt.enquiries@nhs.net +44 (0)161 9187672 Official trial record

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