Authorised (with conditions)Human Pharmacology (Phase I)- OtherInterventional

PHASE Ib STUDY WITH THE COMBINATION OF LB−100 (PP2A INHIBITOR) AND AZENOSERTIB (WEE1 INHIBITOR) IN PATIENTS WITH METASTATIC COLORECTAL CANCER The COLLEE trial

The COLLEE trial is a research study investigating a new way to treat advanced bowel cancer (also known as colorectal cancer) that has spread to other parts of the body. We are testing a combination of two new medicines, called LB-100 and azenosertib. Azenosertib is also known as ZN-c3. The main aim of this early-stage study is to find out if these medicines, when given together, are safe to use and what side effects they might cause. We will also be looking to see if this combination can help to control or shrink the cancer. This information will help us understand if this treatment could be a good option for people in the future.

At a glance

Status

Authorised (with conditions)

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Enrolment target

Start

28 Jun 2024

Metastatic colorectal cancer

What is this study about?

This research study, called the COLLEE trial, is focused on finding new treatments for people who have bowel cancer that has spread to other parts of their body, known as metastatic colorectal cancer. At the moment, we are testing a combination of two new medicines: LB-100 and azenosertib. You might also hear azenosertib called ZN-c3. This is an early-stage study, which means it's one of the first times these specific medicines are being used together in people with this type of cancer.

The main goal of this trial is to carefully check if the combination of LB-100 and azenosertib is safe. We will be looking to see if people experience any side effects, and how severe these might be. We will also keep a close eye on how well people tolerate the treatment. Finding a safe dose of these medicines when given together is really important before we can test them in larger groups of people.

Beyond safety, we will also be investigating whether this combination of medicines can help to treat the cancer effectively. This includes looking to see if the treatment can shrink the cancer, stop it from growing, or help people live longer. The information we gather from this study will help doctors and researchers decide if this new treatment combination has the potential to become a standard treatment option for bowel cancer in the future.

Key takeaways

The COLLEE trial is for advanced bowel cancer that has spread.
It tests two new medicines, LB-100 and azenosertib, together.
The main aim is to check the safety and side effects of this combination.
Researchers will also look to see if the treatment helps control the cancer.
This is an early-stage study, meaning it's one of the first human trials for this combination.

Who may be eligible?

To join the COLLEE trial, you need to be at least 18 years old. There's no upper age limit, so people of all adult ages can be considered. This study is open to both men and women.

The most important health requirement is that you have been diagnosed with bowel cancer that has spread to other parts of your body (metastatic colorectal cancer). The research team will also check other details about your health and medical history to make sure this study is right for you and safe for you to take part in.

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 been diagnosed with bowel cancer that has spread?
Are you able to travel to the study clinic for regular appointments?
Are you willing to follow the study's treatment and testing schedule?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the COLLEE trial, you would receive the study medicines, azenosertib and LB-100, as directed by the study doctors. You would have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These visits are important for the research team to understand how safe the medicines are and how well they are working.

The total length of time you would be involved in the study can vary. You would continue to receive the treatment as long as it is helping you and you are not experiencing significant side effects. Even after you stop the treatment, there will be a follow-up period where the study team will continue to check on your health. The medical team will explain the exact schedule of visits and assessments to you in detail before you make any decision.

Potential risks and benefits

Taking part in any medical trial has potential benefits and risks. A potential benefit of joining this study is that you would receive a new treatment combination that is not yet widely available. This treatment might help to control your cancer, but it's important to remember that it's still being tested, and we don't know for certain how well it will work for everyone. Potential risks include experiencing side effects from the medicines; the research team will monitor you closely for these and manage them as best as possible. You are free to stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

—
Unverified
Netherlands

Common questions

What is 'metastatic colorectal cancer'?

It means bowel (colon or rectal) cancer that has spread from where it started to other parts of your body.

What are LB-100 and azenosertib?

These are two new medicines being tested together to see if they can treat advanced bowel cancer. Azenosertib is also known as ZN-c3.

Why is this called an 'early-stage' study?

It's one of the first times these medicines are being used together in people, mainly to check their safety and find the right dose.

Will this treatment cure my cancer?

This is a research study to see if the treatment can help. We can't guarantee a cure, but we hope to find effective new ways to manage cancer.

What is the main goal of the COLLEE trial?

The main goal is to see if the combination of LB-100 and azenosertib is safe and tolerable, and to get an idea of how well it might work against the cancer.