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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Centr Georges Francois Leclerc Dijon France
IRCCS Humanitas Research Hospital Rozzano Italy
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital General Universitario Gregorio Maranon Madrid Spain
National Institute Of Gastroenterology Saverio De Bellis Research Hospital Castellana Grotte Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Ppnd Txegr Huunybna Uxvshptxdvmg Sabadell Spain
Anrrxvz Ogddwjlicmj Ulqeytozfppfa Senkom Siena Italy
Fpidylsiy Pjib Lh Iaulqagvisnha Bfndtyqup Dft Hymhuekp Ujffnghlpbvrz Le Pcu Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
15.04.2021
Italy Italy
Not recruiting
15.04.2021
Spain Spain
Not recruiting
15.04.2021

Trial locations

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.

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.

Trial ID:
2024-511158-36-00
Protocol code:
ARC-9
NCT ID:
NCT04660812
Trial Phase:
Human Pharmacology (Phase I) – Other

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