Not recruitingRare disease

Study of ALX148 with Trastuzumab, Ramucirumab, and Paclitaxel for Patients with Advanced Gastric or Gastroesophageal Junction 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 is focused on studying a type of cancer known as HER2-overexpressing gastric or gastroesophageal junction adenocarcinoma. This is a form of advanced stomach cancer that has spread and is characterized by an excess of a protein called HER2. The study is investigating a new treatment involving a medication called Evorpacept (ALX148), which is being tested in combination with other cancer treatments: trastuzumab, ramucirumab, and paclitaxel. These medications are administered through an injection into the vein, known as an intravenous infusion.

The purpose of the study is to evaluate how effective the combination of these treatments is in improving the condition of patients with this type of cancer. The study is divided into two phases. In the first phase, the focus is on understanding the response rate of the cancer to the treatment, which means observing how much the cancer shrinks or disappears. In the second phase, the study aims to compare the overall survival of patients receiving the new combination of treatments to those receiving a standard treatment of ramucirumab and paclitaxel.

Participants in the study will receive the treatment over a period of time, and their health will be monitored closely to observe any changes in their cancer and to check for any side effects. The study will also look at how the body processes the new medication, Evorpacept, and whether it triggers any immune response. The trial is expected to continue until 2028, providing valuable information on the potential benefits and risks of this new treatment approach for patients with advanced gastric cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The study involves the administration of several medications through intravenous infusion. The medications include ALX148, trastuzumab, ramucirumab, and paclitaxel. These are given to patients with advanced gastric or gastroesophageal junction cancer that overexpresses HER2.
The treatment is designed to assess the effect of these medications on the response rate and overall survival of patients. The specific dosages and frequency of administration will be determined by the study protocol and the healthcare team.
Step 2
Monitoring and assessment
Throughout the trial, regular monitoring will occur to assess the response to treatment. This includes measuring the size of tumors using imaging techniques and evaluating overall health through blood tests and other assessments.
The objective response rate, which includes complete or partial response to treatment, will be evaluated. Additionally, the duration of response and progression-free survival will be monitored.
Step 3
Adverse event monitoring
Any side effects or adverse events experienced during the trial will be recorded and assessed. This includes the type, frequency, and severity of any reactions to the medications.
Laboratory tests will be conducted to identify any abnormalities that may arise during the treatment period.
Step 4
Immunogenicity and pharmacokinetics
The study will also evaluate the presence of antibodies against ALX148 in the blood, which can indicate an immune response to the medication.
Pharmacokinetic studies will measure the concentration of ALX148 in the blood before and after infusion to understand how the body processes the drug.
Step 5
Quality of life assessment
Quality of life will be assessed using specific questionnaires designed to evaluate the impact of the treatment on daily living and overall well-being.
These assessments will help determine the broader effects of the treatment beyond just the physical response to the cancer.
Step 6
Completion of trial
The trial is expected to continue until November 2028. Upon completion, the data collected will be analyzed to determine the effectiveness and safety of the treatment regimen.
Participants will receive follow-up care as needed based on their individual health status and the outcomes of the trial.

Who can join the trial?

8 criteria

Must be at least 18 years old, unless the region requires a higher minimum age.
Must have a type of stomach cancer called **HER2-overexpressing advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma** that has worsened after previous treatments. This includes treatments targeting HER2 and certain types of chemotherapy.
Must have at least one tumor that can be measured. If the tumor was in an area that received radiation, it must have shown signs of getting worse to be considered measurable.
Must have good function of the bone marrow, kidneys, liver, heart (checked by an ECG), and blood clotting ability.
Must have an **ECOG Performance Status** of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
Must have recovered from any immediate side effects of previous treatments.
If able to have children, must not be pregnant and must agree to use a highly effective form of birth control during the study.
Must agree to participate in the study and follow the study procedures.

Who cannot join the trial?

4 criteria

Patients who have not been diagnosed with **HER2-overexpressing** advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. **HER2-overexpressing** means that the cancer cells have more of a protein called HER2 on their surface, which can affect how the cancer grows.
Patients whose cancer has not progressed after treatment with a **HER2-directed agent**. This is a type of medication that specifically targets the HER2 protein to help control cancer growth.
Patients who have not received **fluoropyrimidine-** or **platinum-containing chemotherapy**. These are types of chemotherapy drugs used to treat cancer.
Patients who are not in the 2nd-line or 3rd-line treatment phase. This refers to the sequence of treatments, where 2nd-line is the second set of treatments given after the first set has failed, and 3rd-line is the third set of treatments.

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Verified sites

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

ARNAS Garibaldi Di Catania
Verified
Catania, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

Trial locations

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Investigated drugs

ALX148
is an investigational medication being studied for its potential to enhance the effectiveness of other cancer treatments. In this trial, it is being tested in combination with other drugs to see if it can improve the response rate and overall survival in patients with advanced gastric or gastroesophageal junction cancer that overexpresses HER2.
Trastuzumab
is a medication used to treat certain types of cancer that have high levels of the HER2 protein. It works by targeting and blocking the HER2 protein, which can help slow or stop the growth of cancer cells.
Ramucirumab
is a medication that targets and blocks a specific protein involved in the formation of blood vessels that supply tumors. By inhibiting this protein, ramucirumab can help slow the growth of tumors by reducing their blood supply.
Paclitaxel
is a chemotherapy drug that works by stopping cancer cells from dividing and growing. It is used to treat various types of cancer, including gastric cancer, by interfering with the normal function of microtubules during cell division.

What is already known about the treatment

ALX148 – ALX148 is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced HER2-overexpressing gastric or gastroesophageal junction adenocarcinoma. This medication is being evaluated for its effectiveness in combination with other drugs like trastuzumab, ramucirumab, and paclitaxel. ALX148 works by targeting specific proteins on cancer cells, helping the immune system to recognize and attack these cells more effectively. It is classified as an immune checkpoint inhibitor, which is a type of drug that helps to boost the body's immune response against cancer.

Investigated diseases

Gastric Adenocarcinoma
This is a type of cancer that begins in the glandular cells of the stomach lining. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause symptoms like stomach pain, nausea, and weight loss. The cancer can spread to other parts of the body, including the liver and lymph nodes. It is often associated with certain risk factors, such as infection with Helicobacter pylori and dietary habits. The disease is more common in older adults and can vary in its aggressiveness.
Gastroesophageal Junction Adenocarcinoma
This cancer occurs where the esophagus meets the stomach, known as the gastroesophageal junction. It typically develops from glandular cells and can be influenced by factors like chronic acid reflux and obesity. 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 subtle early symptoms. The condition is more prevalent in males and older individuals.