Recruiting

Study of ivonescimab with chemotherapy combination for first and second-line treatment in patients with advanced or metastatic gastric and gastroesophageal cancer

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What is this trial about?

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

This clinical trial focuses on patients with advanced or metastatic gastric cancer and esophagogastric junction cancer. The study evaluates a new treatment approach combining ivonescimab (also known as AK112/SMT112) with standard chemotherapy medications. The chemotherapy drugs used in this study include fluorouracil, irinotecan, paclitaxel, oxaliplatin, calcium levofolinate, and folinic acid.

The purpose of this research is to determine how well ivonescimab works when combined with chemotherapy in treating patients with advanced stomach and esophageal junction cancers. The study includes patients whose cancers may have specific biological markers (HER2, PD-L1, or Claudin18.2). These markers are proteins found on cancer cells that can affect how the cancer responds to treatment.

During the study, participants will receive ivonescimab through an intravenous infusion along with their chemotherapy treatment. The treatment will continue as long as patients show benefit from it and do not experience unacceptable side effects. Regular medical examinations and scans will be performed to monitor how the cancer responds to the 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.

Step 1
Initial medical assessment
Your medical condition will be confirmed through examination of gastric cancer or esophagogastric junction cancer
Various tests will be performed to check your liver function, blood count, and kidney function
A pregnancy test will be required for women who can become pregnant
Step 2
Treatment assignment
You will receive a combination of medications through intravenous injection
The treatment includes ivonescimab combined with standard chemotherapy drugs
The chemotherapy medications include: fluorouracil, irinotecan, calcium levofolinate, folinic acid, paclitaxel, and oxaliplatin
Step 3
Regular monitoring
Your response to treatment will be assessed through regular tumor measurements
Your overall health status will be monitored using the ECOG performance status scale
Quality of life assessments will be conducted using specific questionnaires
Any side effects or adverse reactions will be recorded and monitored
Step 4
Ongoing evaluations
Regular scans will be performed to measure your tumor response
Blood tests will continue throughout the treatment period
Your general health and any symptoms will be assessed at each visit
Step 5
Study completion
The study will continue until 2028
Treatment will continue until your disease progresses or you experience unacceptable side effects
Follow-up visits will be scheduled to monitor your long-term health status

Who can join the trial?

13 criteria

You must be 18 years or older
You must be diagnosed with gastric cancer or cancer of the area where the esophagus meets the stomach that has spread to other parts of the body (stage IV) or cannot be removed by surgery
You must have at least one tumor that can be measured using imaging tests
You must be able to perform daily activities with minimal assistance (ECOG score of 0 or 1)
Your blood tests must show: - Adequate white blood cell counts (neutrophils ≥1.5 × 10⁹/L) - Adequate platelet counts (≥100 × 10⁹/L) - Adequate hemoglobin levels (≥9 g/dL)
Your liver function tests must be within acceptable ranges
Your kidney function must be adequate (kidney filtration rate ≥50 mL/min)
Your blood clotting tests must be within normal ranges if you are not taking blood thinners
If you are of childbearing age, you must: - Have a negative pregnancy test before starting the study - Agree to use effective birth control during the study and for 120 days after - Not donate eggs during this period
If you are a male participant, you must: - Use effective birth control if your partner can become pregnant - Not donate sperm during the study and for 120 days after
You must be willing to follow all study requirements, including scheduled visits and tests
You must be affiliated with the Social Security System or equivalent
You must sign an informed consent form before any study procedures begin

Who cannot join the trial?

13 criteria

Prior treatment with anti-PD-1/PD-L1 therapy (a type of immunotherapy that helps your immune system fight cancer cells)
Active brain metastases (cancer that has spread to the brain) that are not stable or require steroids
History of autoimmune diseases (conditions where your immune system attacks healthy cells in your body)
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Significant heart conditions or uncontrolled high blood pressure
Major surgery within 28 days before starting the study treatment
Previous treatment with other experimental drugs within 4 weeks before starting this study
Active bleeding or high risk of bleeding
Pregnant or breastfeeding women
Known allergies to the study medications or their components
Any other serious medical condition that could interfere with study participation
Unable to swallow oral medications
Mental conditions that could affect the ability to follow study procedures

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Verified sites

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

Verified
Centr Georges Francois Leclerc
Dijon, France
Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Ivonescimab is a medication being studied for treating advanced gastric (stomach) and gastroesophageal cancer. It works by targeting specific proteins in cancer cells and helping the immune system fight the cancer. This medication is designed to be used in combination with chemotherapy treatments. Chemotherapy (various standard cancer-fighting medications) is used in combination with ivonescimab to treat cancer. These medications work by killing rapidly dividing cells, including cancer cells, throughout the body.

What is already known about the treatment

Ivonescimab – A novel investigational bispecific antibody being studied in clinical trials for the treatment of advanced or metastatic gastric cancer and esophagogastric junction cancer. The medication is administered intravenously in combination with chemotherapy and works by targeting both VEGF and PD-1 pathways, potentially enhancing anti-tumor immune responses while inhibiting blood vessel formation in tumors. This dual-targeting approach represents an innovative strategy in cancer immunotherapy, particularly for patients with and without specific biomarkers such as HER2, PD-L1, or Claudin18.2.

Investigated diseases

Gastric Cancer
A disease that begins in the cells of the stomach lining and can spread to other parts of the body. The cancer typically develops slowly over many years, starting with pre-cancerous changes in the inner lining of the stomach. It can grow through the stomach's wall and extend to nearby organs or lymph nodes. When advanced, the cancer cells can travel through the bloodstream or lymphatic system to distant organs.
Esophagogastric Junction Cancer
A cancer that forms in the area where the esophagus (food pipe) meets the stomach. This type of cancer develops in the cells at this junction point and can grow into either the esophagus or stomach. The cancer begins in the innermost layer of the tissue and can gradually grow outward through the other layers. As it advances, it can spread to nearby lymph nodes and other organs.
Metastatic Cancer
A condition where cancer cells have spread from their original location to other parts of the body through the bloodstream or lymphatic system. These cells can form new tumors in different organs, creating secondary cancer sites. The new tumors are the same type of cancer as the original tumor.
Locally Advanced Cancer
A cancer that has grown outside the organ where it started but has not spread to distant parts of the body. The tumor has become large or grown into nearby tissues or lymph nodes, making it difficult or impossible to remove surgically. It remains concentrated in one general area of the body.