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Study of ZN-c3, Encorafenib, and Cetuximab for Adults with Metastatic Colorectal Cancer

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a type of cancer called metastatic colorectal cancer, which is a form of cancer that starts in the colon or rectum and has spread to other parts of the body. The study is testing a new treatment combination that includes three medications: azenosertib (also known as ZN-c3), encorafenib, and cetuximab. Azenosertib is a small-molecule inhibitor, which means it is designed to block certain proteins that help cancer cells grow. Encorafenib is a BRAF V600-mutant kinase inhibitor, which targets specific mutations in cancer cells, and cetuximab is a solution for infusion that works by blocking a protein on the surface of cancer cells.

The purpose of this study is to find the best dose of azenosertib when used in combination with encorafenib and cetuximab. The study will also look at how well this combination works in treating metastatic colorectal cancer. Participants in the study will receive these medications and will be monitored by healthcare professionals. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment. The study will take place over several phases, starting with a dose-escalation phase to determine the safest and most effective dose, followed by an expansion phase to further evaluate the treatment's effectiveness.

Throughout the study, participants will have regular check-ups, including blood tests and scans, to monitor their health and the cancer's response to the treatment. The study aims to provide valuable information on the potential benefits and safety of this new treatment combination for people with metastatic colorectal cancer. The trial is expected to continue until the end of 2026, with recruitment having started in July 2023.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, participants will attend an initial visit. During this visit, medical history will be reviewed, and a physical examination will be conducted.

    Blood tests and other necessary assessments will be performed to confirm eligibility for the trial.

  2. Step 2

    Treatment initiation

    Participants will begin treatment with three medications: encorafenib, cetuximab, and azenosertib.

    Encorafenib is taken orally in the form of a film-coated tablet. The dosage and frequency will be determined by the study team.

    Cetuximab is administered through an intravenous infusion. The dosage and frequency will be determined by the study team.

    Azenosertib is taken orally in the form of a film-coated tablet. The dosage and frequency will be determined by the study team.

  3. Step 3

    Regular follow-up visits

    Participants will attend regular follow-up visits to monitor their health and response to the treatment.

    During these visits, blood tests, physical examinations, and other assessments will be conducted to ensure safety and effectiveness of the treatment.

  4. Step 4

    Dose adjustments

    Based on the results of the follow-up visits, the study team may adjust the dosage of the medications to find the most effective and safe dose.

    Participants will be informed of any changes to their treatment plan.

  5. Step 5

    End of treatment

    The treatment will continue until the study team determines it is time to stop, based on the participant's health and response to the medications.

    A final assessment will be conducted to evaluate the overall impact of the treatment.

Who can join the trial?

12 criteria

  • Participants must be 18 years or older.
  • Must have metastatic colorectal cancer confirmed by a doctor.
  • Must have a BRAF V600E mutation in the tumor, confirmed by a lab test.
  • Must have measurable disease as determined by a doctor using specific guidelines.
  • Must have adequate tumor tissue available for analysis, either from a previous sample or a new biopsy.
  • Must have experienced disease progression after 1 or 2 previous treatments for metastatic disease.
  • Must have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
  • Must have adequate bone marrow function, which includes having enough white blood cells, platelets, and hemoglobin.
  • Must have adequate liver and kidney function, which includes normal levels of certain blood tests.
  • Must weigh at least 40 kg (about 88 pounds).
  • Must be able to give informed consent and agree to follow the study requirements.
  • Must be willing and able to attend all scheduled visits and follow the treatment plan and other study procedures.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer that has spread to other parts of the body (metastatic cancer) cannot participate.
  • Patients who have had a different cancer treatment within the last 4 weeks are not eligible.
  • Patients with severe heart problems, such as heart failure or a recent heart attack, cannot join the study.
  • Patients with uncontrolled high blood pressure are not allowed to participate.
  • Patients with active infections that require treatment with antibiotics are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients with known allergies to the study drugs or similar drugs are not eligible.
  • Patients with a history of severe allergic reactions to any medication are excluded.
  • Patients with significant liver or kidney disease cannot participate.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
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Investigated drugs

  • ZN-c3

    is an experimental medication being tested in this clinical trial. It is not yet widely available and is being studied to see how well it works when combined with other treatments for metastatic colorectal cancer. The goal is to find the best dose that patients can tolerate while still being effective against the cancer.

  • Encorafenib

    is a medication used to treat certain types of cancer. It works by blocking the action of a protein that helps cancer cells grow. In this trial, it is being used in combination with other treatments to see if it can help stop the growth of colorectal cancer that has spread to other parts of the body.

  • Cetuximab

    is a type of therapy known as a monoclonal antibody. It targets specific proteins on the surface of cancer cells, helping to slow down or stop their growth. In this study, cetuximab is being used alongside other medications to see if it can improve outcomes for patients with metastatic colorectal cancer.

What is already known about the treatment

ZN-c3 – ZN-c3 is administered orally and is currently being studied in combination with two other medications, encorafenib and cetuximab, for treating adults with metastatic colorectal cancer. This medication is in the clinical trial phase, where researchers are determining the best dose that can be safely given to patients. ZN-c3 works by targeting specific proteins in cancer cells, which helps to stop their growth and spread. It is classified as an investigational drug, meaning it is still being tested and is not yet approved for general medical use.

Investigated diseases

Metastatic Colorectal Cancer – Metastatic colorectal cancer is a type of cancer that originates in the colon or rectum and has spread to other parts of the body, such as the liver or lungs. It begins as a growth, or polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade nearby tissues and spread through the lymphatic system or bloodstream to distant organs. The disease may cause symptoms like changes in bowel habits, blood in the stool, abdominal pain, and weight loss. The progression of metastatic colorectal cancer can vary, with some cases spreading rapidly while others progress more slowly. The spread of cancer to other organs can complicate the disease and affect the body's overall function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502267-37-00Protocol codeZ0011001 (ZN-c3-016)Estimated enrolment82 patientsSponsorK-Group Beta Inc.

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