Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

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

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

13 criteria

  • 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 trial?

3 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

  • Evorpacept

    Evorpacept is an experimental cancer medication currently being studied in clinical trials for treating advanced cancers, including metastatic HER2-positive breast cancer. It is administered through injection and is being tested in combination with other cancer treatments such as trastuzumab and chemotherapy. The drug works by blocking certain signals that help cancer cells hide from the body's immune system, allowing the immune system to better recognize and attack the cancer cells. Evorpacept belongs to a class of medications called immune checkpoint inhibitors, which help the body's natural defenses fight cancer more effectively.

  • Trastuzumab

    Trastuzumab is an approved cancer medication given through intravenous infusion to treat certain types of breast cancer that have high levels of a protein called HER2. It is widely used in clinical practice and has been a standard treatment for HER2-positive breast cancer for many years. The medication works by attaching to the HER2 protein on cancer cells and blocking signals that tell the cancer to grow, while also alerting the immune system to destroy these cells. Trastuzumab is classified as a targeted therapy and monoclonal antibody, meaning it specifically targets cancer cells while leaving normal cells relatively unharmed.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522012-16-00Protocol codeAT148009Estimated enrolment120 patientsSponsorAlx Oncology Holdings Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.