Study of Zolbetuximab combined with Paclitaxel and Ramucirumab for patients with previously treated CLDN18.

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What is this study about?

This study focuses on treating patients with gastro-esophageal adenocarcinoma, a type of cancer affecting the stomach and esophagus, specifically in cases where the tumor is CLDN18.2-positive. The study evaluates a combination treatment approach using three medications: Zolbetuximab (also known as Vyloy), Paclitaxel, and Ramucirumab in patients who have already received one previous treatment for their cancer.

The main purpose of this research is to determine if adding Zolbetuximab to the standard treatment improves survival in patients whose tumors test positive for CLDN18.2 and who have not previously received any CLDN18.2-targeted therapy. The treatment involves receiving medications through intravenous infusion, which means the medicine is given directly into a vein.

During the study, participants will receive treatment for up to 24 months. The medications will be given at regular intervals, with Zolbetuximab administered at specific doses calculated based on body surface area. Throughout the treatment period, doctors will monitor the participants’ health status and track how the disease responds to the treatment combination.

1 Initial treatment preparation

Your participation begins after confirming that you have CLDN18.2-positive gastro-esophageal cancer. This means that at least 75% of your cancer cells show specific characteristics when tested.

You must have already received one previous cancer treatment that has not included medications targeting CLDN18.2.

2 Treatment combination

You will receive three medications as part of this study:

– Zolbetuximab (Vyloy) given through an intravenous infusion

– Paclitaxel given through an intravenous infusion

– Ramucirumab given through an intravenous infusion

3 Monitoring during treatment

Regular assessments will track how your cancer responds to treatment using imaging scans

Your overall health status will be monitored throughout the treatment period

Any side effects will be recorded and addressed

4 Treatment continuation

Treatment will continue until either:

– Your cancer shows signs of progression based on imaging scans

– You experience side effects that prevent continued treatment

– You decide to stop participating in the study

5 Follow-up period

After completing or stopping treatment, your health status will continue to be monitored

The study will track your overall survival time and how long you remain without cancer progression

Who Can Join the Study?

Age 18 or older at the time of signing the consent form
Have a WHO performance status of 0-1 (meaning you are able to carry out all normal activities with minor restrictions)
Have a confirmed diagnosis of metastatic gastroesophageal adenocarcinoma (cancer that has spread from stomach or esophagus to other parts of the body)
Have received one previous treatment (first-line therapy) for your cancer
If you received treatment to prevent cancer return (adjuvant therapy) and the cancer came back during treatment or within 6 months after completing it, this counts as first-line therapy
Your tumor must test positive for CLDN18.2 (a specific protein marker) in at least 75% of cancer cells
Can have any PDL1 score (a protein marker that helps determine response to certain treatments)
Must use effective birth control methods, such as:
- Implants
- Injectable contraceptives
- Oral contraceptives
- Some types of IUDs
- Complete sexual abstinence
- Partner with vasectomy
Must provide written informed consent before any study procedures begin

Who Cannot Join the Study?

Prior treatment with Zolbetuximab or any other therapy targeting CLDN18.2
Active brain or spinal cord metastases (cancer that has spread to brain or spinal cord)
History of other cancers within the past 3 years, except for successfully treated skin cancer or early-stage cancer
Severe heart conditions, including heart failure, unstable heart rhythm, or heart attack within the last 6 months
Uncontrolled high blood pressure
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Significant liver problems (liver function tests more than 2.5 times above normal limits)
Significant kidney problems (creatinine clearance less than 30 mL/min)
Pregnant or breastfeeding women
Known allergies to study medications or their components
Participation in another clinical trial within 30 days before starting this study
Any medical condition that, in the opinion of the study doctor, would make it unsafe to participate in the trial

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Cxffdedmj Uxfahjjoolhbcr Seslyetdz	Woluwe-Saint-Lambert	Belgium
Usavnldbck Ob Accgjnp	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.10.2025

Trial locations

Investigated drugs:

Zolbetuximab

Zolbetuximab is a targeted therapy medication that works by attaching to a specific protein called CLDN18.2 found on some stomach and esophageal cancer cells. It helps the immune system identify and fight cancer cells that have this protein.

Paclitaxel is a chemotherapy medication that works by stopping cancer cells from dividing and growing. It is commonly used to treat various types of cancer, including stomach and esophageal cancer.

Ramucirumab is a targeted therapy medication that works by blocking the formation of new blood vessels that feed cancer cells. By preventing the cancer from developing its own blood supply, it can help slow down or stop tumor growth.

Investigated diseases:

Oesophageal adenocarcinoma

Gastro-esophageal adenocarcinoma – A cancer that develops in the glandular cells of the stomach or esophagus. It begins when cells in the inner lining of these organs start growing uncontrollably and form tumors. The specific subtype mentioned here involves tumors that express a protein called CLDN18.2 on their surface. This cancer can affect how the stomach and esophagus function, potentially interfering with eating and digestion. The disease typically develops gradually, starting from changes in the inner lining of these organs. It can spread from its original location to nearby tissues or other parts of the body.

Trial ID:

2025-521358-41-00

NCT ID:

NCT06962137

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Zolbetuximab combined with Paclitaxel and Ramucirumab for patients with previously treated CLDN18.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?