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Study of DKN-01 with Drug Combination for Patients with Advanced Colorectal Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial is for people with advanced colorectal cancer. The experimental drug being tested is called DKN-01. It is given together with the usual chemotherapy regimens known as FOLFIRI or FOLFOX, and with a targeted medicine called bevacizumab. The chemotherapy regimens contain medicines that are given by an IV (a needle placed in a vein) to kill cancer cells.

The purpose of the study is to find out if adding DKN-01 can lengthen the time patients live without the cancer getting worse, also called progression-free survival. Participants receive the study medicines by IV infusion every two weeks. Treatment continues until the cancer grows, side effects become too strong, or the doctor decides to stop. Throughout the trial, doctors check how the cancer is responding and watch for side effects.

To see how the cancer is responding, patients have regular scans, such as a CT scan, which takes detailed pictures of the inside of the body. Blood tests and physical exams are also done to monitor health. After stopping the study medicines, patients are followed for several months to see how long they stay well.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be assigned to one of two groups. One group will receive the standard treatment, and the other group will receive the standard treatment plus an additional medication called DKN-01.

  2. Step 2

    Treatment administration

    The treatment involves a combination of medications administered through an intravenous (IV) line. This means the medications will be given directly into your bloodstream through a needle in your vein.

    The standard treatment includes a combination of drugs known as FOLFIRI or FOLFOX, along with bevacizumab. These are common treatments for advanced colorectal cancer.

    If you are in the group receiving the additional medication, you will also receive DKN-01.

  3. Step 3

    Medication details

    The medications used in the study include fluorouracil, bevacizumab, calcium folinate, oxaliplatin, irinotecan hydrochloride, and DKN-01.

    These medications are given as a solution for infusion, which means they are mixed with a liquid and slowly administered through the IV line.

  4. Step 4

    Treatment schedule

    The treatment is given in cycles. Each cycle lasts for a specific period, followed by a rest period to allow your body to recover.

    The exact schedule, including the dosage and frequency of each medication, will be explained to you by the study team.

  5. Step 5

    Monitoring and assessments

    Throughout the study, you will have regular check-ups and tests to monitor your health and the effects of the treatment.

    These assessments may include blood tests, imaging scans, and other evaluations to track the progress of your condition.

  6. Step 6

    End of treatment

    The study is expected to continue until September 2025. Your participation may end earlier if the treatment is no longer beneficial or if you choose to withdraw from the study.

    After completing the treatment, you will have follow-up visits to monitor your health and any long-term effects of the treatment.

Who can join the trial?

13 criteria

  • Must have a confirmed diagnosis of advanced colorectal cancer, which means the cancer has spread beyond the colon or rectum.
  • Must have shown disease progression after receiving a first-line treatment that includes a type of drug called fluoropyrimidine, except for a specific combination called FOLFOXIRI.
  • Must have acceptable blood clotting ability, which means blood can clot properly unless on blood-thinning medication.
  • Females who can have children must use a highly effective birth control method during the study and for at least 6 months after the last dose of study drugs. They must also have a negative pregnancy test before starting the study.
  • Males who are not sterile must use a highly effective birth control method during the study and for at least 6 months after the last dose of study drugs. Their female partners should also use effective birth control if they can have children.
  • Must be able to provide written consent, meaning they understand the study and agree to follow its requirements.
  • Must be at least 18 years old in North America or 19 years old in the Republic of Korea.
  • Must have at least one measurable tumor that can be assessed using imaging techniques like CT or MRI.
  • Must have enough tumor tissue available for evaluation before starting the study.
  • Must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
  • Must have acceptable liver function, which means liver tests are within a certain range.
  • Must have acceptable kidney function, which means kidney tests are within a certain range.
  • Must have acceptable blood cell counts, which means having enough white blood cells, platelets, and hemoglobin.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer other than colorectal cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or assessments.
  • Patients who have a medical condition that might interfere with the study treatment or affect their safety.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications or their ingredients.
  • Patients who have a history of certain heart conditions or other serious illnesses.
  • Patients who are unable to provide informed consent.
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Investigated drugs

  • DKN-01

    is an experimental medication being tested in this clinical trial. It is designed to work by targeting specific pathways in cancer cells, potentially slowing down or stopping their growth. The goal of adding DKN-01 to the treatment is to see if it can improve the outcomes for patients with advanced colorectal cancer when used alongside other standard treatments.

  • FOLFIRI

    is a combination of chemotherapy drugs used to treat colorectal cancer. It includes three different medications that work together to stop cancer cells from growing and dividing. This combination is often used when the cancer has spread or returned after initial treatment.

  • FOLFOX

    is another combination of chemotherapy drugs used to treat colorectal cancer. Like FOLFIRI, it consists of multiple medications that work together to attack cancer cells. It is commonly used as a standard treatment for advanced colorectal cancer.

  • Bevacizumab

    is a medication that helps prevent the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, bevacizumab can help slow down the growth of cancer. It is often used in combination with chemotherapy to treat various types of cancer, including colorectal cancer.

What is already known about the treatment

DKN-01 – DKN-01 is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials as a potential treatment for advanced colorectal cancer. The main therapeutic indication for DKN-01 is to improve progression-free survival in patients with this type of cancer. At the molecular level, DKN-01 works by targeting and inhibiting a specific protein involved in cancer cell growth, which may help slow down or stop the progression of the disease. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the disease progresses, cancer cells can invade and destroy normal tissue nearby and may spread to other parts of the body. The progression of colorectal cancer can vary, with some cases growing slowly over several years. Symptoms may not appear until the cancer has advanced, making regular screenings important for early detection.
Trial detailsLast updated 9 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501465-40-00Protocol codeDEK-DKK1-P207Estimated enrolment156 patientsSponsorLeap Therapeutics Inc.

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