Active not recruitingPHASE2INTERVENTIONAL

Bemarituzumab in FGFR2b+ Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative Chemotherapy

This clinical trial is testing a new treatment called bemarituzumab when given alongside standard chemotherapy for advanced cancer of the stomach or where the food pipe meets the stomach. This is for patients whose cancer has spread and has a particular genetic feature called FGFR2b+. These patients will have already tried at least one other chemotherapy treatment that didn't work well enough. The study aims to see how well these combinations work in shrinking the cancer, how long patients live without their cancer growing, and what the side effects are like. Patients will be given bemarituzumab with one of three different chemotherapy combinations, chosen by their doctor based on their usual care.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrolment target

126

Start

03 Mar 2025

Estimated completion

01 Mar 2028

Metastatic Gastro-esophageal Adenocarcinoma

What is this study about?

This study is looking into a new treatment approach for a type of advanced cancer that affects the stomach or the area where the food pipe joins the stomach (called the gastroesophageal junction). This particular cancer is advanced, meaning it has spread to other parts of the body, and cannot be cured by surgery. The focus is on patients whose cancer has a specific change in its genes, known as FGFR2b-positive. This genetic change can sometimes make it harder for standard treatments to work.

The main idea behind this study is to combine a new drug, bemarituzumab, with standard chemotherapy treatments that are already used for this type of cancer. Bemarituzumab is designed to target the FGFR2b change, hoping to make the chemotherapy more effective. Researchers want to find out if this combination can help shrink the cancer, stop it from growing for longer, and improve how long people live comfortably.

Patients taking part in this study will be split into three groups, and each group will receive bemarituzumab along with a different standard chemotherapy combination. These combinations include irinotecan, paclitaxel plus ramucirumab, or trifluridine/tipiracil. Your doctor will decide which chemotherapy combination is best for you based on what's usually given for your condition. The study will also carefully check for side effects and how the treatment affects your quality of life.

Key takeaways

This study is for advanced stomach or gastroesophageal junction cancer.
It combines a new drug (bemarituzumab) with existing chemotherapy.
It's for patients whose cancer has a specific genetic marker (FGFR2b+).
Participants must have had previous chemotherapy.
The study aims to see how well the treatment works and its side effects.
Your doctor chooses which chemotherapy you receive with bemarituzumab.

Who may be eligible?

To join this study, you need to be at least 18 years old and have advanced cancer of the stomach or gastroesophageal junction that has spread and can't be removed by surgery. Your cancer must have a specific genetic marker called FGFR2b. You should have already received at least one course of chemotherapy for your advanced cancer and it didn't work as well as hoped, or you couldn't tolerate it. If your cancer has a different marker called HER2/neu, you can still join if you've already had treatment for that.

Your general health needs to be good enough to take part, meaning you can look after yourself for the most part, and your blood tests for things like your liver, kidneys, and blood cells need to be within a healthy range. Researchers也会需要 access to a sample of your cancer tissue to check for the FGFR2b marker. You'll also need to be expected to live for more than 12 weeks to join.

There are specific rules for joining different groups within the study. For example, if you're going to receive the trifluridine/tipiracil combination, you must have already had at least two previous chemotherapy treatments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have advanced stomach or gastroesophageal junction cancer?
Has your cancer spread and can it not be removed by surgery?
Has your cancer been tested and found to be FGFR2b-positive?
Have you already had at least one chemotherapy treatment for your advanced cancer?
Is your general health good enough to take part?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given the new drug bemarituzumab along with one of three standard chemotherapy treatments. Your doctor will choose which chemotherapy combination is most suitable for you. You will have regular appointments for check-ups, blood tests, and scans to see how the treatment is working and to monitor for any side effects. The study will look at how your cancer responds to treatment, how long it takes before your cancer grows again, and how you feel generally. You will also be asked about your quality of life during the treatment. The total length of your participation will depend on how you respond to the treatment, but you will be monitored closely throughout.

Potential risks and benefits

Taking part in this study might offer some potential benefits, such as receiving a new treatment combination that could be more effective for your cancer than standard options alone. However, there are also potential risks involved, as all medications can have side effects. These can range from mild to more serious, and the study team will monitor you closely for any adverse reactions. You will be fully informed about these potential risks before deciding to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (35)

Uniklinik RWTH Aachen
Verified postcode
Aachen, Germany
Klinikum St. Marien
Verified postcode
Amberg, Germany
Universitätsklinikum Augsburg
Verified postcode
Augsburg, Germany
Helios Klinikum Bad Saarow
Verified postcode
Bad Saarow, Germany
Klinikum Neukölln Vivantes Netzwerk für Gesundheit GmbH Klinlinik für Innere Medizin - Hämatologie und Onkologie
Verified postcode
Berlin, Germany
Charité - Universitätsmedizin Berlin Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CVK)
Verified postcode
Berlin, Germany
VIVANTES Berlin Friedrichshain
Verified postcode
Berlin, Germany
Klinikum Bielefeld gem. GmbH Klinik für Hämatologie, Onkologie und Palliativmedizin
Verified postcode
Bielefeld, Germany
Klinikum Chemnitz
Verified postcode
Chemnitz, Germany
St.-Johannes-Hospital
Verified postcode
Dortmund, Germany
Gemeinschaftspraxis Hämatologie-Onkologie
Verified postcode
Dresden, Germany
Universitätsklinikum Düsseldorf Klinik für Gastroenterologie, Hepatologie und Infektiologie Gastroonkologische Studienzentrale
Verified postcode
Düsseldorf, Germany

Common questions

What is advanced stomach or gastroesophageal junction cancer?

This is cancer that started in your stomach or where your food pipe meets your stomach, and it has spread to other parts of your body.

What does FGFR2b-positive mean?

This refers to a specific genetic change found in your cancer cells that the new drug, bemarituzumab, is designed to target.

Will I definitely receive the new drug?

Yes, if you join this study, you will receive bemarituzumab combined with a standard chemotherapy treatment.

What if I've already had chemotherapy?

This study is specifically for people who have already tried at least one chemotherapy treatment for their advanced cancer.

How long will I be in the study?

The length of your participation will depend on how your body responds to the treatment and whether side effects occur.