A Study of Evorpacept Combined with Trastuzumab and Chemotherapy for Patients with Metastatic HER2-Positive Breast Cancer

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What is this study about?

This study is looking at breast cancer that has spread to other parts of the body and is known as HER2-positive, which means the cancer cells have too much of a certain protein called HER2 on their surface. The study will test a combination of treatments that includes evorpacept, which is an experimental medicine also known by its code name ALX148, together with trastuzumab, a medicine that targets the HER2 protein, and one chemotherapy medicine chosen from the following options: capecitabine, eribulin, gemcitabine, paclitaxel, or vinorelbine. These chemotherapy medicines work by stopping cancer cells from growing and dividing. The purpose of this study is to find out how well this combination of medicines works in shrinking or stopping the growth of tumors in people whose cancer has gotten worse after previous treatments.

People taking part in this study will receive evorpacept and trastuzumab through a needle into a vein, along with one of the chemotherapy medicines, which may be given either through a vein or as tablets taken by mouth depending on which one is chosen. The treatments will be given in cycles that last 21 days, and participants will continue to receive treatment as long as it is working and not causing unacceptable side effects. During the study, doctors will regularly check how the cancer is responding to treatment using imaging scans, and they will monitor for any side effects or problems that may occur. Blood samples will be taken to measure the levels of the study medicines in the body and to check for any immune reactions to evorpacept.

The study will measure how many people have their tumors shrink or disappear completely with this treatment combination, and how long the treatment keeps working before the cancer starts growing again. Doctors will also track how long people live overall and will carefully record any side effects that occur, including their type and severity. The study will collect information about how the body processes evorpacept and whether the immune system develops antibodies against it.

1 Initial assessment and baseline measurements

At the start of the study, your doctor will perform imaging scans to measure at least one tumor that can be tracked throughout the treatment.

Blood samples will be collected to check for HER2 copy number amplification in circulating tumor DNA. This is a genetic marker that helps determine if the treatment may work for you.

Your heart function will be assessed to ensure your left ventricular ejection fraction (a measure of how well your heart pumps blood) is at least 50 percent.

Blood tests will be performed to check your kidney function. Your creatinine clearance (a measure of how well your kidneys filter waste) must be at least 30 milliliters per minute.

Blood tests will also check your liver function, including bilirubin (a substance produced when red blood cells break down) and liver enzymes called aspartate transaminase and alanine transaminase.

Your overall physical condition will be evaluated using a scale from 0 to 1, where 0 means you are fully active and 1 means you have some restrictions but can still perform light work.

2 Treatment with evorpacept, trastuzumab, and chemotherapy

You will receive evorpacept given through a vein (intravenous infusion). The specific dose and schedule will be determined by your doctor.

You will also receive trastuzumab given through a vein (intravenous infusion). Trastuzumab is a targeted therapy that works against HER2-positive breast cancer cells.

Along with evorpacept and trastuzumab, you will receive one of the following chemotherapy medications, chosen by your doctor based on what is most suitable for you:

Capecitabine: tablets taken by mouth. This medication comes in 150 milligram and 500 milligram strengths.

Eribulin: a solution given through a vein (intravenous injection) at a concentration of 0.44 milligrams per milliliter.

Gemcitabine: a powder mixed into a solution and given through a vein (intravenous infusion). Available in 200 milligram and 1000 milligram doses.

Paclitaxel: a concentrated solution given through a vein (intravenous infusion) at a concentration of 6 milligrams per milliliter.

Vinorelbine: a concentrated solution given through a vein (intravenous infusion) at a concentration of 10 milligrams per milliliter.

The combination of these three medications (evorpacept, trastuzumab, and one chemotherapy drug) will continue throughout your participation in the study.

3 Regular monitoring and imaging assessments

Throughout the study, your tumors will be regularly assessed using imaging scans. These assessments will follow a standard method called Response Evaluation Criteria in Solid Tumors version 1.1, which measures changes in tumor size.

The imaging scans will be reviewed both by your doctor and by independent medical experts who do not know which treatment you are receiving. This ensures objective evaluation of how the treatment is working.

Your doctor will monitor how your cancer responds to treatment, including whether tumors shrink, stay the same size, or grow.

The time it takes for your cancer to progress and how long any response to treatment lasts will be recorded.

4 Safety monitoring and blood tests

Throughout the study, you will be monitored for any side effects or adverse reactions to the medications. Any side effects will be recorded, including their type, how often they occur, how severe they are, when they happen, and whether they are related to the study drugs.

Side effects will be graded using a standard scale called the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Regular blood tests will be performed to check for any abnormal laboratory values. These will also be recorded and graded for severity.

Blood samples will be collected at specific times to measure the levels of evorpacept in your bloodstream. This helps researchers understand how your body processes the medication.

Blood samples will also be tested to see if your body develops antibodies against evorpacept, which could affect how the medication works.

5 Long-term follow-up

Your survival and overall health status will be tracked throughout the study period.

The study is expected to continue until June 2027, though your individual participation may vary depending on how you respond to treatment and any side effects you experience.

Who Can Join the Study?

You must have at least one measurable lesion, which means a tumor that can be seen and measured on imaging scans using a specific measurement system called RECIST version 1.1
Your cancer must have gotten worse during or after your most recent treatment
Your heart’s pumping function must be at least 50 percent, measured by a test called LVEF, which stands for left ventricular ejection fraction and shows how well your heart pumps blood
You must be able to receive one of these chemotherapy medicines: capecitabine, eribulin, gemcitabine, paclitaxel, or vinorelbine
Your kidneys must work well enough, with a creatinine clearance of at least 30, which is a measure of how well your kidneys filter waste from your blood
Your liver must work well enough, shown by blood tests: your total bilirubin, a substance made when red blood cells break down, must be no more than 1.5 times the normal upper limit, or no more than 3 times if you have a condition called Gilbert syndrome
Your liver enzyme levels called AST and ALT must be no more than 3 times the normal upper limit, or no more than 5 times if cancer has spread to your liver
Your ECOG Performance Status must be 0 or 1, which means you are able to carry out normal activities or have only slight limitations in physical activity
Your expected survival time must be at least 3 months
You must have recovered from side effects of previous treatments, procedures, and surgeries to your normal state or to mild severity, except for side effects that cannot be reversed but do not pose a safety risk in your doctor’s opinion
You must have HER2 positive breast cancer confirmed by tissue examination, meaning your cancer cells have high levels of a protein called human epidermal growth factor receptor 2
You must have received at least one prior treatment including a medicine called T-DXd for advanced or metastatic breast cancer, which means cancer that has spread beyond the breast to other parts of the body
If you received treatment before surgery that resulted in cancer returning within 6 months of completing T-DXd, this will count as a line of treatment for metastatic disease

Who Cannot Join the Study?

The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why patients cannot participate are not available in this document.
Generally, clinical trials have exclusion criteria to ensure patient safety and study accuracy, but these specific details would need to be obtained from the complete study documentation.
If you are interested in participating, the research team would review your complete medical history to determine if you meet all requirements for the study.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Universitario Basurto	Bilbao	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Csvmco Lsle Bzqjow	Lyon	France
Ayosfcn Uwega Sxnjwqnda Llezio Dw Bijjcph	Bologna	Italy
Hmaalsbm Dj Lv Sdtlb Cnlj I Slor Pok	Barcelona	Spain
Aiambmh Oisqpzvjjje Pufu Gbqmmdlk Xqcdh	Bergamo	Italy
Hdiyuswi Vlcg dsipvclk	Barcelona	Spain
Iidfshap Cancr	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	09.01.2026
Italy	Recruiting	09.01.2026
Spain	Recruiting	09.01.2026

Trial locations

Investigated drugs:

Evorpacept is an investigational medication being studied as a cancer treatment. It works by helping the immune system recognize and fight cancer cells. In this trial, it is being tested in combination with other treatments to see if it can help patients with breast cancer that has spread to other parts of the body.

Trastuzumab is a targeted therapy medication used to treat certain types of breast cancer. It works by blocking a protein called HER2 that helps cancer cells grow. This medication is given to patients whose breast cancer cells have too much of this HER2 protein.

Chemotherapy refers to powerful medications that kill cancer cells or stop them from growing. In this trial, participants will receive a single chemotherapy drug (the specific drug may vary) along with the other study medications to help fight the cancer.

Breast Cancer – Breast cancer is a disease where abnormal cells in the breast tissue grow uncontrollably and form a tumor. The cancer can begin in different parts of the breast, most commonly in the milk ducts or the glands that produce milk. As the disease progresses, cancer cells can multiply and spread within the breast tissue. In metastatic breast cancer, the cancer has spread beyond the breast to other parts of the body such as bones, lungs, liver, or brain. Some breast cancers are classified as HER2-positive, meaning the cancer cells have higher than normal levels of a protein called human epidermal growth factor receptor 2, which promotes cancer cell growth. The disease can progress at different rates depending on various factors including the specific characteristics of the cancer cells.

Trial ID:

2025-522012-16-00

Protocol code:

AT148009

NCT ID:

NCT07007559

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study of Evorpacept Combined with Trastuzumab and Chemotherapy for Patients with Metastatic HER2-Positive Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?