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Study on Gallium (68Ga) Tezatabep Matraxetan PET for Evaluating HER2 Status in Patients with Gastro-Esophageal and HER2-Low Breast Cancer

Verified siteInvestigationalNo placebo

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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 two types of cancer: gastroesophageal cancer and breast cancer. The trial is particularly interested in cases where these cancers show a specific characteristic known as HER2-expression. HER2 is a protein that can affect the growth of cancer cells. The study will use a special imaging technique called PET/CT to look at how a new treatment, known by its code name 68Ga-ABY-025, interacts with these cancers. This treatment involves a solution that is injected into the body and helps to highlight cancer cells during the scan.

The purpose of the study is to evaluate how well the 68Ga-ABY-025 treatment can identify HER2 status in cancerous tumors and any spread of the disease, known as metastases. The study will involve patients with gastroesophageal cancer and those with a subtype of breast cancer called HER2-low. Participants will undergo PET/CT scans to see how the treatment is taken up by the cancer cells. This will help doctors understand more about the HER2 status of the tumors, which is important for planning the best treatment approach.

Throughout the study, participants will receive the 68Ga-ABY-025 treatment and have PET/CT scans to monitor the uptake of the treatment in their tumors. The study will also look at how the treatment affects the cancer over time, including any changes in the size or spread of the tumors. The trial aims to provide valuable information on the effectiveness of this new imaging method in assessing HER2 status, which could lead to better treatment strategies for patients with these types of 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 visit
Upon joining the study, an initial visit is scheduled. During this visit, a detailed explanation of the study is provided, and any questions are answered.
A written consent form is signed to confirm participation in the study.
Step 2
Screening and eligibility
A series of tests and assessments are conducted to confirm eligibility for the study. This includes checking for specific medical conditions such as gastro-esophageal cancer or breast cancer with HER2-expression.
Eligibility criteria include being at least 18 years old, having a certain performance status, and having a life expectancy of more than 12 weeks.
Step 3
Preparation for imaging
Preparation for the imaging procedure involves scheduling a PET/CT scan using a special solution called [68Ga]Ga-ABY-025.
The solution is administered through an intravenous injection, which means it is injected directly into a vein.
Step 4
Imaging procedure
The PET/CT scan is performed to measure the HER2 status in tumors. This involves lying still on a table while the scanner takes images of the body.
The scan helps to identify the presence and extent of cancer by showing how the solution is taken up by the tumors.
Step 5
Follow-up visits
Regular follow-up visits are scheduled to monitor health and any changes in the condition. These visits may include additional scans and assessments.
The frequency and duration of these visits depend on the specific requirements of the study and the individual's health status.
Step 6
End of study
At the end of the study, a final assessment is conducted to evaluate the overall health and any effects of the study procedures.
Participants are provided with information about the study results and any further steps that may be necessary for their health care.

Who can join the trial?

9 criteria

Must be 18 years or older.
Must have given written consent to participate in the study.
Must have metastatic disease (cancer that has spread to other parts of the body) due to one of the following:
- Gastroesophageal adenocarcinoma (a type of cancer in the stomach and esophagus) with confirmed HER2-positive status, scheduled for treatment targeting HER2.
- Non-small cell lung cancer with HER2-positive status, scheduled for treatment targeting HER2.
- HER2-low metastatic breast cancer (cancer that has spread and has low levels of HER2), either newly diagnosed or previously treated.
- Must have at least one metastatic lesion (cancer spot) that is 10 mm or larger available for biopsy (a procedure to take a small sample of tissue).
- Must have at least one (and up to five) additional metastatic index lesions (cancer spots) that are 10 mm or larger for evaluating treatment effect.
- Must have a WHO performance status of 2 or less, which means the patient is able to carry out all self-care but is unable to carry out any work activities; up and about more than 50% of waking hours.
- Must have an expected survival of more than 12 weeks.

Who cannot join the trial?

4 criteria

Patients who do not have **gastro-esophageal cancer** with **HER2-expression** or **breast cancer** with **low HER2-expression** cannot participate. **HER2** is a protein that can affect the growth of cancer cells.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Both **male** and **female** patients are eligible, so exclusion is not based on gender.
Patients who are part of a **vulnerable population** are not eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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Karolinska University Hospital
Verified
Solna, Sweden

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Investigated drugs

[68Ga]Ga-ABY-025 is a special type of imaging agent used in this clinical trial. It is designed to help doctors see certain proteins, called HER2, in tumors using a PET/CT scan. HER2 is a protein that can affect how cancer grows and spreads. By using this imaging agent, doctors can get a clearer picture of the HER2 status in both the main tumor and any areas where the cancer has spread. This helps in understanding the nature of the cancer and planning the best treatment approach for patients with certain types of cancer, like gastric or breast cancer. The information gathered from this imaging can be compared to other standard tests to ensure accuracy.

Gallium (68Ga) Tezatabep Matraxetan

What is already known about the treatment

[68Ga]Ga-ABY-025 – This medication is administered through an injection and is used in PET/CT scans to help visualize and measure the HER2 status in certain types of cancer, specifically gastro-esophageal cancer and breast cancer with low HER2 expression. It is currently being studied in clinical trials to determine its effectiveness in non-invasively assessing HER2 levels in tumors. The main therapeutic indication is to aid in the diagnosis and treatment planning for cancers that express the HER2 protein. At the molecular level, it works by binding to the HER2 protein on cancer cells, allowing doctors to see these cells more clearly on imaging scans. It is classified as a radiopharmaceutical used for diagnostic purposes in oncology.

Investigated diseases

Gastroesophageal Cancer with HER2 Expression
This type of cancer occurs in the region where the esophagus meets the stomach. It is characterized by the overexpression of the HER2 protein, which can promote the growth of cancer cells. The disease typically begins with the development of malignant cells in the lining of the esophagus or stomach. As it progresses, these cancerous cells can invade deeper layers of the esophagus or stomach and may spread to nearby lymph nodes and other organs. The progression can lead to symptoms such as difficulty swallowing, weight loss, and chest pain. Over time, the cancer may metastasize to distant parts of the body.
Breast Cancer with Low HER2 Expression
This form of breast cancer is identified by a lower level of HER2 protein expression on the surface of cancer cells. It begins with the formation of malignant cells in the breast tissue, which can grow and divide uncontrollably. The progression of the disease can lead to the formation of a lump or mass in the breast, changes in breast shape, or skin dimpling. As the cancer advances, it may spread to nearby lymph nodes and potentially to other parts of the body. The low HER2 expression can influence the behavior and growth rate of the cancer. Symptoms may include breast pain, swelling, or changes in the nipple.