AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Double-blind, randomized, placebo-controlled, study to evaluate the safety and efficacy of HRX215 in participants after major hepatectomy, preceded by two open pilot parts in participants after minor and after major hepatectomy due to colon carcinoma metastases

This research study is looking at a new medicine called HRX215. It's for patients who have had surgery to remove bowel cancer that has spread to their liver. The main aims are to check if HRX215 is safe to use and if it helps the liver recover after this type of surgery. Researchers will compare HRX215 with a dummy medicine (placebo) to see any differences. They will also look at how the body handles the medicine and how much of it reaches the bloodstream. This study is taking place in phases, meaning different stages of testing, to make sure the medicine is carefully evaluated.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

HepaRegeniX GmbH

Enrolment target

Start

20 Apr 2026

colon carcinoma metastases

What is this study about?

This study is investigating a new medicine called HRX215 for people who have undergone open-heart surgery because their large intestine (colon) cancer has spread to their liver. This type of surgery is called a hepatectomy. The study has a careful design which means some people will receive the new medicine HRX215 while others will receive a dummy medicine (a placebo). This is to accurately compare the effects of the new medicine.

The main aim of the study is to find out if HRX215 is safe and how well people tolerate it after their surgery. Researchers will closely monitor for any side effects and changes to their health. They will also be looking at how the body processes HRX215. A secondary goal is to see if HRX215 helps the liver recover and grow back after surgery, by measuring liver size at different times. If successful, this medicine could potentially help patients recover better after their operation.

This is an "integrated" Phase I and Phase II study. Phase I studies usually test a new medicine on a small number of healthy people to check its safety and how the body handles it. Phase II studies then involve a larger group of patients with the condition to see if the medicine works and to learn more about its safety. Combining these phases means they are gathering this information efficiently.

Key takeaways

This study tests a new medicine (HRX215) for liver recovery after surgery for bowel cancer that has spread.
It aims to check both the safety and potential benefits of HRX215.
You might receive the new medicine or a dummy medicine.
Participation involves regular check-ups, blood tests, and possibly scans.
The study is for adults (18+) who have had specific liver surgery.
Your health will be closely monitored throughout the study.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

You would be considered for the study if you have had surgery to remove parts of your liver because of bowel cancer that had spread there. This is a specific type of surgery called a hepatectomy.

The study will have other specific rules about who can take part, which a doctor will discuss with you. These rules help make sure the study is safe for everyone involved and that the results are clear.

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?
Have you had surgery to remove part of your liver because of bowel cancer spread?
Are you able to attend regular hospital visits for check-ups and tests?
Are you willing to potentially receive either the new medicine or a dummy medicine?
Are you prepared to follow all study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive either the new medicine HRX215 or a dummy medicine, delivered in white capsules of a specific size. This will involve regular visits to the clinic where doctors and nurses will monitor your health very closely.

During these visits, you will have various checks, including measuring your heart rate and blood pressure (vital signs), physical examinations, and blood tests to look at things like blood counts and sugar levels. They will also take blood samples to understand how your body processes the study medicine.

Towards the end of the study, specifically for its main part, you will have scans (like CT scans) to measure your liver size. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new medicine that could help your liver recover after surgery, or getting very close medical attention from the study team. However, as with any new medicine, there are potential risks, including possible side effects from HRX215, some of which might be serious. Because you might receive the dummy medicine, there's also a chance you won't get any active treatment from the study drug. It's important to remember that joining is completely voluntary, and you have the right to withdraw from the study at any time without it affecting your usual medical care.

Locations (3)

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

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Unverified
France
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Unverified
Spain
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Unverified
Germany

Common questions

What is HRX215?

HRX215 is a new medicine being tested in this study to see if it's safe and helps people who have had liver surgery for bowel cancer spread.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctor will know if you are receiving the new medicine or the dummy medicine. This helps ensure fair and unbiased results.

Will I definitely get the new medicine?

No, you have an equal chance of receiving either the new medicine HRX215 or a dummy medicine (placebo). This is part of the study design to compare the effects.

Why are there different 'phases'?

New medicines go through different phases of testing. Phase I checks safety, and Phase II starts to look at how well the medicine works, usually in patients with the condition. This study combines these stages.

What are 'AEs/SAEs'?

AEs/SAEs stand for 'Adverse Events' and 'Serious Adverse Events'. These are any unwanted medical problems that happen during the study, which the research team will closely monitor and record.