Study of Bemarituzumab with Irinotecan, Paclitaxel, Ramucirumab, or Trifluridine/Tipiracil for Advanced Stomach or Gastroesophageal Cancer in Patients After Chemotherapy

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What is this study about?

This clinical trial is focused on studying a type of cancer called adenocarcinoma that affects the stomach or the area where the stomach meets the esophagus, known as the gastroesophageal junction. Specifically, it involves patients whose cancer is advanced or has spread to other parts of the body and is positive for a protein called FGFR2b. The study is testing a treatment called Bemarituzumab, also known by its code name AMG 552, to see how effective it is when combined with other standard cancer treatments. These treatments include Irinotecan, Paclitaxel with Ramucirumab, and Trifluridine/Tipiracil, which are all medications used to treat cancer.

The purpose of the study is to evaluate how well Bemarituzumab works in combination with these other treatments for patients who have already tried at least one other chemotherapy treatment without success. The study will involve different groups of patients receiving different combinations of these medications. Some patients may receive a combination of Bemarituzumab and Irinotecan, others may receive Bemarituzumab with Paclitaxel and Ramucirumab, and another group may receive Bemarituzumab with Trifluridine/Tipiracil. There is also a possibility of receiving a placebo, which is a substance with no active medication.

Participants in the study will receive their assigned treatment over a period of up to 12 months. The treatments will be given either as tablets taken by mouth or as infusions, which are medications delivered directly into the bloodstream through a vein. The study aims to determine the effectiveness of these treatment combinations in shrinking the cancer or stopping it from growing. The results will help doctors understand if these combinations can be a better option for treating this type of cancer in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Blood tests and other diagnostic procedures are performed to ensure adequate blood, liver, and kidney function.

2 treatment allocation

Participants are assigned to one of three treatment groups based on previous treatments received.

Group 1 receives bemarituzumab combined with irinotecan.

Group 2 receives bemarituzumab combined with paclitaxel and ramucirumab.

Group 3 receives bemarituzumab combined with trifluridine/tipiracil.

3 treatment administration

For bemarituzumab, irinotecan, paclitaxel, and ramucirumab, the medication is administered through an intravenous infusion.

Trifluridine/tipiracil is taken orally in the form of film-coated tablets.

The specific dosage and frequency of administration depend on the treatment group and individual health conditions.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and manage any side effects.

Scheduled visits and examinations are required throughout the study period.

Participants are expected to comply with all study protocols, including follow-up assessments.

5 end of treatment

The study is estimated to conclude by March 31, 2028.

Final assessments are conducted to evaluate the overall response to the treatment.

Who Can Join the Study?

The patient must provide a signed informed consent form, which means they agree to participate in the study after understanding all the details.
The patient must have good blood, liver, and kidney function. This includes having enough white blood cells, platelets, and hemoglobin, which is a protein in red blood cells. The liver and kidney tests should be within certain limits.
The patient must have normal blood clotting ability, which means their blood can form clots properly to stop bleeding.
Female patients who can have children, or male patients with female partners who can have children, must agree to use birth control or not have sexual intercourse during the study and for at least 6 months after the last treatment. Male patients should not donate sperm during this time. Female patients must have a negative pregnancy test before starting the study.
The patient must be willing and able to follow the study rules, including attending all treatments, visits, and tests.
The patient must be 18 years or older.
The patient must have been diagnosed with a specific type of advanced or metastatic cancer in the stomach or where the stomach meets the esophagus, which cannot be removed by surgery.
The patient must have a disease that can be measured or evaluated using specific medical guidelines.
The patient must have received at least one previous treatment that included certain cancer drugs, unless they could not tolerate or were not eligible for these drugs. If the cancer returned within 6 months after previous treatments, those treatments count as one line of therapy.
The patient must have tumor samples available for specific testing related to the study.
Patients with a certain type of tumor (HER2/neu-positive) can join if they have had previous targeted therapy for this tumor type.
The patient 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 patient must have a life expectancy of more than 12 weeks.

Who Cannot Join the Study?

Patients who do not have FGFR2b-positive cancer. This means the cancer must have a specific marker called FGFR2b.
Patients whose cancer is not advanced or metastatic. Advanced means the cancer is in a late stage, and metastatic means it has spread to other parts of the body.
Patients who are not diagnosed with adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinoma is a type of cancer that starts in glandular cells.
Patients who are not within the specified age range for the trial.
Patients who are not willing or able to follow the trial procedures.
Patients who have other medical conditions that might interfere with the trial.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the trial medications.
Patients who have certain infections or diseases that could affect the trial results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Hospital Universitario De Jaen	Jaen	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
HELIOS Kliniken Schwerin GmbH	Schwerin	Germany
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Sze Arfi Hvnhgpfa	Herne	Germany
Ilpcyhpc Cyengv Dayugujyincwliier	L'hospitalet De Llobregat	Spain
Knuwxpve Ehegszomviumhoewaofpygoy Hfjtyodvbcclghahu	Essen	Germany
Hjiiusxb Vzyi djzthjdc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	15.11.2024
Spain	Not yet recruiting	15.11.2024

Trial locations

Investigated drugs:

Bemarituzumab is a medication being studied for its potential to treat patients with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. It targets a specific protein called FGFR2b, which is found in some cancer cells, and may help to slow down or stop the growth of these cancer cells.

Irinotecan is a chemotherapy drug used in this trial to help treat cancer by interfering with the DNA of cancer cells, which can prevent them from growing and dividing.

Paclitaxel is another chemotherapy medication included in the trial. It works by stopping cancer cells from dividing, which can slow down or stop the growth of the cancer.

Ramucirumab is a medication that works by blocking a protein that helps cancer cells grow new blood vessels. By doing this, it can help to starve the cancer cells of the nutrients they need to grow.

Trifluridine/tipiracil is a combination of two drugs used in this trial. Trifluridine is a type of chemotherapy that gets incorporated into the DNA of cancer cells, disrupting their function. Tipiracil helps to maintain the levels of trifluridine in the body, enhancing its effectiveness against cancer cells.

Adenocarcinoma of the Stomach – This is a type of cancer that begins in the glandular cells of the stomach lining. It often develops slowly over many years and may not cause symptoms in the early stages. As it progresses, it can lead to symptoms such as stomach pain, nausea, and weight loss. The cancer can spread to other parts of the body, including the liver and lymph nodes. Advanced stages may involve the cancer spreading beyond the stomach to nearby organs. It is often associated with certain risk factors, including diet and infection with Helicobacter pylori.

Adenocarcinoma of the Gastroesophageal Junction – This cancer occurs where the esophagus meets the stomach, known as the gastroesophageal junction. It typically arises from the glandular cells in this area and can be linked to conditions like gastroesophageal reflux disease (GERD). As the disease progresses, it may cause difficulty swallowing, chest pain, and unintended weight loss. The cancer can invade nearby tissues and spread to distant organs. It is often diagnosed at an advanced stage due to the subtlety of early symptoms. Risk factors include obesity, smoking, and a diet low in fruits and vegetables.

Trial ID:

2024-512484-31-00

NCT ID:

NCT06680622

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Bemarituzumab with Irinotecan, Paclitaxel, Ramucirumab, or Trifluridine/Tipiracil for Advanced Stomach or Gastroesophageal Cancer in Patients After Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?