RecruitingPHASE1, PHASE2INTERVENTIONAL

A Clinical Study of Arfolitixorin in Patients With mCRC

This study is looking at a new medicine called arfolitixorin for people with bowel cancer that has spread (metastatic colorectal cancer). Currently, there's a standard combination of medicines used, including one called leucovorin. Arfolitixorin is similar to leucovorin but is designed to work more directly, potentially benefiting more patients and being more effective. The study aims to find the safest and most effective dose of arfolitixorin when given with other standard chemotherapy medicines. Researchers also want to see if this new approach works better than the current standard treatment. This information will help doctors understand if arfolitixorin could be a good new option for future patients.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Isofol Medical AB

Enrolment target

Start

10 Apr 2025

Estimated completion

31 Dec 2029

Metastatic Colorectal Cancer (mCRC)

What is this study about?

This research study is about finding better ways to treat bowel cancer that has spread to other parts of the body, also known as metastatic colorectal cancer. Currently, patients receive a combination of medicines that includes a drug called leucovorin. Leucovorin helps other chemotherapy drugs work better against cancer cells. Scientists have developed a new medicine, arfolitixorin, which is very similar to leucovorin but is thought to work more directly and potentially be more effective for a wider range of patients.

The main goal of this study is to compare arfolitixorin with leucovorin. Researchers want to find out if arfolitixorin, when given with other standard cancer medicines, is safe and if it works as well as, or even better than, the current treatment. They are also trying to find the best and safest amount (dose) of arfolitixorin to give. This helps ensure that patients get enough of the medicine to fight the cancer effectively, without causing too many unwanted side effects.

Previous studies with arfolitixorin have shown it to be safe and to work similarly to leucovorin. However, those studies suggested that higher doses might be needed to get an even better effect on the cancer. This new study will test these higher doses and also carefully look at how the medicines are given, including the exact timing, to see if that makes a difference in how well arfolitixorin works. All this research is vital for developing new and improved treatments for bowel cancer.

Key takeaways

New medicine (arfolitixorin) for bowel cancer that has spread.
Compares arfolitixorin to standard treatment (leucovorin).
Aims to find the safest and most effective dose.
Treatment is given every two weeks by drip.
Regular checks (scans, blood tests) monitor your progress.
This study is currently being conducted in Germany.

Who may be eligible?

This study is for adults aged 18 or over who have bowel cancer that has spread to other parts of the body. You would need to be suitable for the usual first-line combination treatment for this type of cancer. This includes having specific genetic features identified in your cancer cells (like a 'RAS mutation' or 'wild-type RAS/BRAF' depending on the study part and location of the tumour).

You would also need to be fit enough to take part. This means having good results from blood and organ function tests, and being able to perform your daily activities without too much difficulty. For women, it's important not to be pregnant or planning to get pregnant, and to use effective contraception if you could become pregnant.

To check if you are suitable, doctors will need to review your medical history, recent scans, and have a sample of your tumour tissue available for examination.

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 bowel cancer that has spread?
Are you suitable for first-line standard chemotherapy combinations?
Are your blood test results and organ functions within healthy ranges?
If you are a woman, are you not pregnant and using effective contraception?
Is a sample of your tumour tissue available for review?

Answer every question to see your result.

What does participation involve?

If you join this study, the treatment will be given to you through a drip into a vein every two weeks. The treatment will continue for as long as it is helping you and you are feeling well enough to receive it. There isn't a fixed end date for treatment.

Throughout the study, you'll have regular checks to see how you are doing. This will include physical examinations, blood and urine tests, and scans like CT or MRI every few months to see how the cancer is responding. These checks also help the doctors keep an eye on any side effects you might experience.

This study has two main parts. In the first part, you might receive one of several different doses of arfolitixorin to help researchers find the best dose. In the second part, you would be randomly assigned to receive either arfolitixorin (at one of two chosen doses) or the standard leucovorin treatment. This is like flipping a coin to decide which group you are in.

After your treatment finishes, you'll have a final check-up and then regular follow-up contacts, often by phone, for up to two years. This is to gather information on your long-term health and any other treatments you might receive.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new medicine that could be more effective than current treatments, or helping advance medical knowledge for future patients. However, there are also potential risks, as arfolitixorin is still being tested and its full effects are not yet known. You might experience side effects, similar to or different from those caused by standard chemotherapy. The research team will explain all known risks to you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Charité - Universitaetsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting
Universitaetsklinikum Essen AöR, Department of Medical Oncology
Verified postcode
Essen, Germany· Not yet recruiting
Muenchen Klinik gGmbH, Klinik für Onkologie und Hämatologie
Verified postcode
München, Germany· Not yet recruiting

Common questions

What is metastatic colorectal cancer?

It's a type of bowel cancer that has spread from where it started to other parts of your body.

What is arfolitixorin?

It's a new medicine being tested, similar to a standard drug called leucovorin, which helps chemotherapy work better.

Will I definitely get the new medicine?

In the second part of the study, you have an equal chance of receiving arfolitixorin or the standard treatment, decided by chance.

Where is this study taking place?

This particular study is happening in Germany, not in the UK.

How long will I be on treatment?

You'll receive treatment every two weeks for as long as it's helping you and you're feeling well enough to continue.

How to find out more

Roger Tell, MD, PhD

roger.tell@isofolmedical.com +46760293911 Official trial record

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