Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An open-label phase II prospective clinical trial to investigate safety, tolerability, maximum tolerated dose and anti-tumor effect for SCO-101 in combination with FOLFIRI as a safe and efficient treatment modality in metastatic or advanced colorectal cancer (mCRC) patients with acquired FOLFIRI resistant cancer disease

This research trial is investigating a new treatment approach for people with advanced bowel cancer that has spread to other parts of the body (metastatic) and is no longer responding to their current FOLFIRI chemotherapy. The study will test a new medicine called SCO-101, given alongside FOLFIRI, to see if this combination can be a safe and effective way to treat the cancer. Researchers will carefully check for any side effects and determine the best dose of SCO-101 to give. They will also measure if the new treatment helps to shrink the tumours. This is a Phase II trial, meaning it's an earlier stage study focusing on safety and finding the right dose, as well as getting an initial idea of how well it works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Scandion Oncology A/S

Enrolment target

Start

19 Nov 2024

Metastatic Colorectal Cancer

What is this study about?

This study is for people who have advanced bowel cancer, also known as metastatic colorectal cancer. This means the cancer has spread from where it started to other parts of the body. If you're considering this trial, it's likely your cancer has previously been treated with a common chemotherapy combination called FOLFIRI, but it's unfortunately stopped working as well as it used to. The main goal of this trial is to investigate if adding a new drug, SCO-101, to your standard FOLFIRI treatment can be a safe and helpful way to continue fighting the cancer.

The researchers will closely monitor participants to understand the side effects of this new combination. This helps them determine the highest dose that can be given safely without causing too many severe problems. They will also be looking to see if the SCO-101 and FOLFIRI combination has a positive effect on the cancer, such as shrinking tumours or stopping them from growing further.

This is a 'Phase II' trial, which means it's an important step in developing new treatments. These types of trials focus on making sure the treatment is safe for people and finding the best dose. They also give an early idea of how effective the new treatment might be. If this trial shows promising results, it could lead to larger studies and potentially a new treatment option for people whose bowel cancer has become resistant to FOLFIRI.

Key takeaways

This study is for advanced bowel cancer no longer responding to FOLFIRI.
It tests a new drug (SCO-101) with FOLFIRI chemotherapy.
Main goals are to check safety, find the best dose, and see if it shrinks tumours.
It's a Phase II trial, focusing on early safety and effectiveness.
You will receive active treatment, not a dummy drug.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part.

The most important health requirement is that you have advanced bowel cancer (meaning it has spread to other parts of the body) and your current FOLFIRI chemotherapy treatment is no longer working as effectively as it once did. The doctors will also check other aspects of your health to make sure it's safe for you to take part, including looking at your general fitness and how well your liver and kidneys are working.

There might be other medical conditions or previous treatments that would prevent you from joining, so the doctors will review your full medical history carefully. They are looking for people who are well enough to tolerate the treatment and whose cancer fits the specific criteria 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.

Are you 18 years old or older?
Do you have advanced bowel cancer that has spread?
Has your bowel cancer previously been treated with FOLFIRI?
Is your FOLFIRI treatment no longer working as effectively?
Are you generally well enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the new drug SCO-101 alongside the standard FOLFIRI chemotherapy. The study involves regular visits to the clinic to receive your treatment and to have various tests. These tests include blood tests, body scans (like CT or MRI scans) to check your cancer, and physical examinations. These are done to carefully monitor how you are responding to the treatment and to check for any side effects.

Throughout the study, doctors and nurses will ask you about any symptoms or side effects you might be experiencing. All side effects will be carefully recorded. Your treatment will continue as long as it is helping you and you are not experiencing severe side effects. After your treatment finishes, you will have follow-up visits or contact for up to four weeks to make sure any late side effects are identified and managed. The full length of your participation will depend on how you respond to the treatment, but monitoring for side effects will continue for a set period after your last dose.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. The potential benefit of this study is that the new combination of SCO-101 with FOLFIRI might help control your advanced bowel cancer more effectively than current treatments, especially if your cancer has become resistant to FOLFIRI. However, there's no guarantee it will work for everyone. Potential risks include experiencing side effects from the new drug combination, which can be mild to severe and may be different from standard FOLFIRI side effects. The research team will carefully monitor you for any problems. It's important to remember that you have the right to leave 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
Spain

Common questions

What is FOLFIRI chemotherapy?

FOLFIRI is a standard combination of chemotherapy drugs (Fluorouracil, Leucovorin, and Irinotecan) often used to treat advanced bowel cancer.

What does 'metastatic' mean?

Metastatic means the cancer has spread from its original location in the bowel to other parts of your body.

What is a 'Phase II' clinical trial?

A Phase II trial is an early stage of human testing that mainly focuses on whether a new treatment is safe and finding the best dose, as well as getting an initial idea of how effective it might be.

Will I receive a placebo (dummy treatment)?

No, in this study, all participants will receive the new drug SCO-101 in combination with the standard FOLFIRI chemotherapy.

How long will I be in the study?

The length of time you participate will depend on how your cancer responds to the treatment and whether you have any side effects. You will also be monitored for a few weeks after your last treatment dose.