Not recruiting

Study on the Safety and Effectiveness of Etrumadenant, Quemliclustat, and Zimberelimab in Patients with Metastatic Colorectal Cancer

Verified siteRegistered 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 treatments for 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 testing several treatment combinations that include the medications Quemliclustat (also known as AB680), Etrumadenant (also known as AB928), and Zimberelimab (also known as AB122). These medications are being tested in combination with other treatments like Bevacizumab, Fluorouracil, Regorafenib, Oxaliplatin, and Calcium Folinate.

The purpose of the study is to evaluate how effective and safe these treatment combinations are for patients with metastatic colorectal cancer. Participants in the study will receive different combinations of these medications, and their health will be monitored to see how the cancer responds to the treatment and to check for any side effects. The study is designed to help researchers understand which combinations of treatments work best for this type of cancer.

Throughout the study, participants will receive regular check-ups and assessments to track their progress. The study aims to provide valuable information that could lead to better treatment options for people with metastatic colorectal cancer in the future.

The research process

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

Step 1
Joining the study
Upon joining the study, the patient will be assigned to a specific cohort based on their previous treatment history and current health status.
The study focuses on patients with metastatic colorectal cancer, evaluating the effectiveness and safety of various treatment combinations.
Step 2
Treatment administration
The patient will receive a combination of medications, which may include quemliclustat, etrumadenant, bevacizumab, fluorouracil, regorafenib, oxaliplatin, zimberelimab, and calcium folinate.
Medications are administered in various forms such as capsules, tablets, and solutions for injection or infusion.
The specific dosage and frequency will depend on the treatment regimen assigned to the patient.
Step 3
Monitoring and assessments
Throughout the study, the patient's response to treatment will be closely monitored using criteria such as the Response Evaluation Criteria in Solid Tumors (RECIST).
Regular assessments will be conducted to evaluate the progression-free survival, objective response rate, and overall survival.
Step 4
Safety evaluations
The study includes safety evaluations to monitor any adverse effects that may arise from the treatment combinations.
The patient's health and well-being will be assessed regularly to ensure the treatment's safety and tolerability.
Step 5
Completion of the study
The study is expected to continue until approximately July 2025, with the duration of participation varying based on individual response and treatment outcomes.
Upon completion, the patient's overall health and treatment response will be reviewed to determine the next steps in their care.

Who can join the trial?

10 criteria

Participants must be **male or female** and **18 years or older** at the time of signing the consent form.
For **Cohort B**, the disease must have worsened during or after no more than two different treatments for **metastatic colorectal cancer**. These treatments should have included **oxaliplatin** and **irinotecan** with a **biologic agent**.
The cancer must be **metastatic colorectal adenocarcinoma**, confirmed by examining tissue samples under a microscope.
The disease must be **measurable**, meaning there is at least one tumor that can be measured. If the tumor was treated with radiation before, it can only be considered measurable if it has clearly grown since the radiation.
The participant must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The participant must have a **life expectancy of at least 3 months**, as determined by the study doctor.
The participant must have **adequate blood and organ function**.
The participant must test **negative for HIV, Hepatitis B, and Hepatitis C**.
The participant must agree to either **abstain from sex** or use **contraceptive methods** with female partners who can become pregnant. They must also agree not to **donate sperm** for 30 days after the last dose of etrumadenant, 90 days after the last dose of zim, and 180 days after mFOLFOX-6 and bev, whichever is longer.
For **Cohort A**, the disease must have worsened after no more than one previous treatment for **metastatic colorectal cancer**. This treatment should have included **oxaliplatin** or **irinotecan** with a **biologic agent**.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer than metastatic colorectal cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients who are not in the age range specified for the study cannot participate. The study is for certain age groups only.
Patients who are not able to safely tolerate the treatment combinations being tested cannot participate. Tolerability refers to how well a patient can handle the side effects of a treatment.
Patients who are part of a vulnerable population that the study is not designed to include cannot participate. Vulnerable population refers to groups of people who may need special protection or consideration in research.

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Verified sites

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

Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

AB928
is a medication being studied for its potential to enhance the effectiveness of other cancer treatments. It is being tested in combination with other therapies to see if it can help improve outcomes for patients with metastatic colorectal cancer. The goal is to determine if AB928 can help shrink tumors or slow their growth.
Etruma
is another medication involved in the trial. It is being used in combination with other treatments to assess its ability to fight cancer. The study aims to evaluate how well etruma works in reducing tumor size or preventing the cancer from getting worse, as well as to monitor its safety and any side effects it may cause.

What is already known about the treatment

Etruma – Etruma is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating metastatic colorectal cancer. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for etruma is to help manage and treat metastatic colorectal cancer. At the molecular level, etruma works by targeting specific pathways that cancer cells use to grow and spread, thereby inhibiting their proliferation. It is classified pharmacologically as an antineoplastic agent, which means it is designed to combat tumor cells.

Investigated diseases

Metastatic colorectal cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It typically progresses through stages, starting in the lining of the colon or rectum and eventually moving to nearby lymph nodes and distant organs, such as the liver or lungs. The disease often develops from polyps, which are small growths on the inner wall of the colon or rectum that can become cancerous over time. As the cancer spreads, it can cause symptoms like changes in bowel habits, blood in the stool, and abdominal pain. 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, making it more challenging to manage.