Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Safety and Effectiveness of Magrolimab with Bevacizumab and Drug Combination for Patients with Advanced Metastatic Colorectal Cancer

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the treatment of metastatic colorectal cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study is evaluating the safety and effectiveness of a new treatment combination. The treatment involves a medication called Magrolimab, which is a humanized monoclonal antibody targeting a protein called CD47, used in combination with other medications: Bevacizumab, a drug that inhibits the growth of blood vessels in tumors, and a chemotherapy regimen known as FOLFIRI. FOLFIRI includes three drugs: 5-fluorouracil, irinotecan, and leucovorin, which work together to stop cancer cells from growing and dividing.

The purpose of this study is to assess how well the combination of Magrolimab, Bevacizumab, and FOLFIRI works in patients who have already received treatment for their advanced cancer but are not eligible for certain other therapies. Participants in the study will be randomly assigned to receive either the new combination treatment or the standard treatment of Bevacizumab and FOLFIRI. The study will monitor the participants over a period of time to evaluate the progression of the disease and any side effects experienced.

Throughout the study, participants will receive the medications through intravenous infusions, which means the drugs are delivered directly into the bloodstream through a vein. The study aims to provide valuable information on whether the addition of Magrolimab to the existing treatment regimen can improve outcomes for patients with metastatic colorectal cancer. The trial will help determine the best dose and assess the safety of the new treatment combination.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of magrolimab, bevacizumab, and FOLFIRI (a combination of fluorouracil, irinotecan, and leucovorin). The other group will receive bevacizumab and FOLFIRI without magrolimab.

  2. Step 2

    Treatment administration

    You will receive the medications through an intravenous infusion, which means the medicine will be given directly into your vein. The specific dosages and frequency of administration will be determined by the study team based on your individual needs and the study protocol.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and other necessary assessments to ensure your safety and to evaluate the effectiveness of the treatment.

    You will be asked to report any side effects or changes in your health to the study team immediately.

  4. Step 4

    End of treatment

    The treatment phase will continue until the study's end date or until it is determined that the treatment is no longer beneficial for you. The estimated end date for the study is September 15, 2024.

  5. Step 5

    Final assessment

    At the end of the study, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment. This will help in understanding the effectiveness and safety of the treatment combination.

Who can join the trial?

11 criteria

  • Individuals who have been previously treated for **inoperable metastatic colorectal cancer (mCRC)**. This means the cancer has spread and cannot be removed by surgery.
  • Individuals who cannot receive **checkpoint inhibitor therapy**. This is a type of treatment that helps the immune system fight cancer.
  • Individuals with cancer that started in the **colon or rectum** and has been confirmed by a doctor. This does not include cancer that started in the appendix or anal canal.
  • Individuals whose cancer has gotten worse after at least one previous treatment. This treatment must have included certain types of chemotherapy and possibly other drugs like **bevacizumab**, **cetuximab**, or **panitumumab**.
  • Individuals with **measurable disease**. This means the cancer can be measured in size using specific criteria.
  • Individuals with an **ECOG performance status** of 0 or 1. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Individuals with a **life expectancy** of at least 12 weeks.
  • Individuals with adequate **blood counts**. This means having enough red blood cells, white blood cells, and platelets.
  • Individuals with adequate **liver function**. This means the liver is working well enough.
  • Individuals with adequate **renal function**. This means the kidneys are working well enough.
  • Other criteria may apply as defined by the study protocol.

Who cannot join the trial?

10 criteria

  • Patients who have not been previously treated for their advanced colorectal cancer cannot participate.
  • Patients who have a different type of cancer other than metastatic colorectal cancer are not eligible.
  • Patients with a history of severe allergic reactions to any of the study drugs cannot join the trial.
  • Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, are not allowed to participate.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Patients with active infections, such as hepatitis or HIV, cannot join the trial.
  • Patients who have had a major surgery within the last 4 weeks are not allowed to participate.
  • Patients with a history of heart problems, such as a heart attack or heart failure, are not eligible.
  • Patients who have received certain treatments, like chemotherapy or radiation, within a specific time frame before the study starts cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Magrolimab

    is a medication being studied for its potential to help the immune system fight cancer. It works by blocking a specific signal that cancer cells use to avoid being attacked by the body's immune cells. In this trial, researchers are looking at how well magrolimab works when combined with other cancer treatments for people with advanced colorectal cancer that cannot be removed by surgery.

  • Bevacizumab

    is a medication that helps to stop the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, bevacizumab can help slow down or stop the growth of cancer. In this trial, it is used in combination with other treatments to see if it can improve outcomes for patients with advanced colorectal cancer.

  • FOLFIRI

    is a combination of three different chemotherapy drugs used to treat colorectal cancer. It includes 5-fluorouracil, irinotecan, and leucovorin. 5-fluorouracil works by interfering with the cancer cell's ability to make DNA, which is necessary for cell growth. Irinotecan helps to stop cancer cells from dividing and growing. Leucovorin is used to enhance the effectiveness of 5-fluorouracil. Together, these medications aim to reduce the size of tumors and slow the progression of cancer.

What is already known about the treatment

Magrolimab – Magrolimab is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its potential use in treating metastatic colorectal cancer (mCRC), a type of cancer that has spread beyond the colon or rectum. The medication works by targeting and blocking a specific protein on cancer cells, which helps the immune system recognize and destroy these cells. Magrolimab is classified as an immunotherapy drug, which means it helps the body's immune system fight cancer.

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. It typically begins as a growth, called a 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 to distant organs, most commonly the liver and lungs. The disease may cause symptoms such as changes in bowel habits, blood in the stool, abdominal pain, and weight loss. The progression of metastatic colorectal cancer can vary, with some cases advancing more rapidly than others. The spread of cancer cells to other parts of the body is a key characteristic of this disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500177-13-00Protocol codeGS-US-587-6156Estimated enrolment127 patientsSponsorGilead Sciences Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.