Study on the Safety and Effectiveness of Domvanalimab, Zimberelimab, and Quemliclustat in Adults with Advanced Upper Gastrointestinal Cancer

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What is this study about?

This clinical trial is focused on studying treatments for patients with advanced upper gastrointestinal tract cancers, which include cancers of the stomach, gastroesophageal junction, and esophagus. The study will explore the safety and effectiveness of different treatment combinations. These treatments involve several medications: Domvanalimab (also known as AB154), Zimberelimab (also known as AB122), and Quemliclustat (also known as AB680). Additionally, the study will include chemotherapy drugs such as Calcium Folinate, Oxaliplatin, and Fluorouracil. Some participants may receive a placebo as part of the study.

The purpose of the study is to assess how well these drug combinations work and how safe they are for patients with these types of cancers. Participants will receive the treatments over a period of up to 24 months. The study will monitor the participants’ health and any side effects they may experience. The goal is to understand the potential benefits and risks of these treatments for people with advanced upper gastrointestinal tract cancers.

Throughout the study, participants will undergo regular check-ups and assessments to track their response to the treatment. This includes measuring the size of the cancer and checking for any changes in the participants’ health. The study aims to provide valuable information that could help improve treatment options for people with these challenging types of cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the patient meets the study criteria.

The patient must have a confirmed diagnosis of advanced upper gastrointestinal tract cancer and meet other health requirements.

2 treatment plan discussion

The treatment plan is discussed, including the medications involved and their administration methods.

The patient is informed about the combination therapies, which may include calcium folinate, domvanalimab, zimberelimab, quemliclustat, oxaliplatin, and fluorouracil.

3 medication administration

Medications are administered as solutions for infusion, which means they are given through a vein over a period of time.

The frequency and duration of administration depend on the specific treatment plan and the patient’s response to the therapy.

4 regular monitoring

Regular monitoring is conducted to assess the patient’s response to the treatment and to check for any side effects.

This includes physical examinations, blood tests, and imaging studies as needed.

5 follow-up visits

Scheduled follow-up visits are necessary to evaluate the effectiveness of the treatment and to make any necessary adjustments.

These visits help in tracking the progress and managing any adverse effects that may occur.

6 end of trial assessment

At the end of the trial, a final assessment is conducted to determine the overall impact of the treatment.

The patient is provided with information about the results and any further steps that may be needed for their care.

Who Can Join the Study?

Participants must have a confirmed diagnosis of locally advanced, unresectable, or metastatic gastric, GEJ (gastroesophageal junction), or esophageal adenocarcinoma. This means the cancer is in a stage that cannot be removed by surgery or has spread to other parts of the body.
Participants should have a life expectancy of at least 3 months, as assessed by the study doctor.
Participants must have an ECOG Performance Score of 0-1. This is a scale used to assess how the disease affects a patient’s daily living abilities, where 0 means fully active and 1 means some symptoms but nearly fully active.
Participants need to have at least one measurable target lesion, which is a specific area of cancer that can be measured to see if the treatment is working, according to RECIST v1.1 criteria. These are guidelines used to measure cancer response to treatment.
Participants must have adequate organ and marrow function, meaning their organs and bone marrow are working well enough to participate in the study.
Participants should be able to provide a previous tumor sample that can be used for PD-L1 testing. This is a test to see if the cancer has certain proteins that might respond to the study treatment.
Participants can be of any gender.
Participants must be within the age range specified by the study, which includes adults.

Who Cannot Join the Study?

Patients with other types of cancer that are not related to the gastrointestinal tract (the part of the body that digests food) cannot participate.
Patients who have had a different type of cancer in the past, unless it was successfully treated and has not returned, are excluded.
Patients with serious heart problems, such as heart failure or a recent heart attack, are not eligible.
Patients with uncontrolled high blood pressure cannot take part in the study.
Patients with active infections, including HIV (a virus that affects the immune system), hepatitis B or hepatitis C (viruses that affect the liver), are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had an organ transplant are not eligible.
Patients who are currently participating in another clinical trial are excluded.
Patients with a known allergy to any of the study drugs cannot take part.
Patients with a history of autoimmune diseases (conditions where the immune system attacks the body) are not eligible.
Patients with a history of drug or alcohol abuse within the past year are excluded.
Patients who have received certain treatments for cancer, such as chemotherapy or radiation, within a specific time frame before the study starts, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Prive Des Cotes D’armor	Plerin	France
Centre Francois Baclesse	Caen	France
Ifgjgmlp Rejzfaoq De Cyczbt Du Mmkdxbzqwdq	Montpellier	France
Cadlym Laia Btidkr	Lyon	France
Atfzgvnsvv Pgjdhwuq Hskanrtt Dl Mcmmarfkm	Marseille	France
Coosri Ohhwk Lxoqjzm	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	13.10.2022

Trial locations

Investigated drugs:

Domvanalimab is a medication being studied for its potential to help the immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. In this trial, it is being tested to see if it can help treat advanced cancers of the stomach and esophagus.

Zimberelimab is another medication that is part of this study. It is designed to boost the body’s immune response against cancer cells. By targeting certain proteins, zimberelimab may help the immune system recognize and destroy cancer cells more effectively. This trial is exploring its use in treating advanced cancers of the stomach and esophagus.

Quemliclustat is a medication that is being tested for its ability to interfere with cancer cell growth. It works by targeting specific pathways that cancer cells use to grow and spread. In this trial, quemliclustat is being combined with other therapies to see if it can improve treatment outcomes for patients with advanced cancers of the stomach and esophagus.

Investigated diseases:

Gastrointestinal carcinoma

Gastrointestinal Tract Malignancies – These are cancers that occur in the digestive system, which includes the stomach, intestines, and other organs involved in digestion. They begin when cells in these areas grow uncontrollably, forming tumors. As the disease progresses, these tumors can invade nearby tissues and spread to other parts of the body. Symptoms may include changes in bowel habits, abdominal pain, and weight loss. The progression can vary depending on the specific location and type of cancer within the gastrointestinal tract.

Upper Gastrointestinal Tract Cancer – This type of cancer affects the upper part of the digestive system, including the esophagus, stomach, and the beginning of the small intestine. It starts with abnormal cell growth in these areas, leading to tumor formation. As it advances, the cancer can spread to surrounding tissues and distant organs. Symptoms often include difficulty swallowing, indigestion, and nausea. The disease’s progression depends on the cancer’s location and how early it is detected.

Advanced Upper Gastrointestinal Tract Malignancies – These are cancers in the upper digestive system that have progressed to a more severe stage. They typically involve significant tumor growth and may have spread to other parts of the body. Symptoms can be more pronounced and may include severe pain, significant weight loss, and difficulty eating. The disease’s progression is marked by increased tumor size and potential metastasis. The impact on the body can be extensive, affecting overall health and function.

Trial ID:

2024-511917-40-00

Protocol code:

ARC-21(EDGE-Gastric)

NCT ID:

NCT05329766

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Domvanalimab, Zimberelimab, and Quemliclustat in Adults with Advanced Upper Gastrointestinal Cancer

What is this study about?

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