Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Randomized Phase 2 Study of DKN-01 Plus FOLFIRI/FOLFOX and Bevacizumab Versus FOLFIRI/FOLFOX and Bevacizumab as Second-line Treatment of Advanced Colorectal Cancer (DeFianCe)

This research study, called DeFianCe, is investigating a new drug called DKN-01. It's for people with advanced bowel cancer that has either spread or come back after initial treatment. The study aims to see if adding DKN-01 to standard chemotherapy (FOLFIRI or FOLFOX) and another drug called bevacizumab (like Aybintio) is more effective than the standard treatment alone. Researchers will compare how long people live without their cancer growing, and also look at how many people respond to treatment, how long that response lasts, and overall survival. Safety is also a key focus, monitoring for serious side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Leap Therapeutics Inc.

Enrolment target

Start

10 Feb 2023

Colorectal Cancer

What is this study about?

This study is for people who have advanced bowel cancer. This means the cancer has spread to other parts of the body or has come back after earlier treatments. Doctors are trying to find better ways to treat this type of cancer. In this study, they are testing a new drug called DKN-01. They want to see if adding DKN-01 to the standard treatments (which include chemotherapy drugs like FOLFIRI or FOLFOX, and another drug like bevacizumab, also known as Aybintio) helps patients more than the standard treatments alone.

The main goal is to find out if patients taking DKN-01 along with the standard treatment live longer without their cancer getting worse, compared to those only receiving the standard treatment. The researchers will also carefully watch how the cancer responds to the treatment, how long any improvements last, and the overall length of time people live. Safety is very important, so they will also be tracking any side effects people might experience.

This is a 'Phase 2' study, which means it's still in the early stages of testing this new drug combination. The information gathered from this study will help doctors decide if DKN-01 is a promising treatment option that should be studied further in larger trials.

Key takeaways

This study tests a new drug, DKN-01, for advanced bowel cancer.
It compares DKN-01 plus standard treatment to standard treatment alone.
The main goal is to see if DKN-01 helps people live longer without their cancer growing.
Participation involves regular hospital visits, treatments, blood tests, and scans.
You will be randomly assigned to a treatment group.
You can leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with advanced bowel cancer. Both men and women can take part.

To be considered for the study, you would typically need to have had some previous treatment for your bowel cancer, and the cancer would have started to grow again or spread. There will be specific medical checks to make sure your overall health is suitable for the study treatments.

Important things that might mean you can't join include having certain other serious health conditions or if your cancer has specific genetic characteristics that would make this treatment unsuitable for you. Your doctor will carefully review all your medical information to see if this study is a good fit for you.

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 progressed or come back?
Have you already had some previous treatment for your bowel cancer?
Are you generally well enough to receive chemotherapy treatments?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive the new drug DKN-01 along with the standard chemotherapy and bevacizumab. The other group will receive just the standard chemotherapy and bevacizumab. You won't get to choose which group you're in.

You'll have regular visits to the hospital or clinic for your treatments, which are given as infusions (drips). These visits will also include blood tests, scans (like CT scans) to check your cancer, and check-ups with the study doctors and nurses to monitor your health and any side effects. The treatment will continue for as long as it's helping you, or until you experience significant side effects.

Even after you stop study treatment, you'll continue to have follow-up appointments to track your health and how your cancer is doing. The total duration of your participation can vary, as it depends on how your body responds to the treatment and your overall health, but follow-up can continue for several years.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new drug DKN-01 proves to be more effective than standard treatment in controlling your cancer. However, there's no guarantee the treatment will work for you, and it's also possible you could get side effects from any of the drugs. These side effects can range from mild to serious, and the study team will monitor you closely for them. You are always free 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.

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Unverified
Germany

Common questions

What is 'advanced colorectal cancer'?

This means bowel cancer that has spread to other parts of your body, or has returned after previous treatments.

What is DKN-01?

DKN-01 is a new drug being tested to see if it can help stop bowel cancer from growing when combined with other treatments.

What does 'randomized' mean?

It means you'll be put into one of the treatment groups by chance, like drawing lots. You won't choose which group you're in.

Will I know if I'm getting the new drug?

No, this is usually a 'blinded' study, meaning neither you nor your doctor will know which treatment group you are in to keep the results fair.

What are the standard treatments mentioned?

These are common chemotherapy combinations like FOLFIRI or FOLFOX, usually given with a drug called bevacizumab (like Aybintio), which targets blood vessel growth in tumours.