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A study testing zimberelimab, domvanalimab, and sacituzumab govitecan for patients with PD-L1 positive advanced triple-negative breast cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study is looking at a specific type of breast cancer called triple-negative breast cancer that has spread to other parts of the body or cannot be removed by surgery. Triple-negative breast cancer is a form of breast cancer where the cancer cells do not have certain proteins on their surface, which makes it different from other types of breast cancer. The study focuses on patients whose cancer tests positive for a marker called PD-L1, which is a protein found on some cancer cells. The treatment being studied involves a combination of three medications given through a vein: zimberelimab (also known by the code name AB122), domvanalimab (also known by the code name AB154), and sacituzumab govitecan (marketed as Trodelvy). These medications work in different ways to help the body fight cancer cells. This combination is being tested as the first treatment for patients who have not yet received any therapy for their advanced disease.

The main goal of this study is to find out how well this three-drug combination works in shrinking or stopping the growth of tumors in patients with this specific type of breast cancer. The study will measure how many patients experience a reduction in the size of their tumors or have their tumors disappear completely. The researchers will also look at how long patients live without their disease getting worse, how long patients survive overall, and how long any positive response to treatment lasts. Additionally, the study will examine the safety of this treatment combination and any side effects that may occur.

Patients in this study will receive the three medications through infusions into a vein at specific time intervals over a treatment period that can last up to twelve months. Throughout the study, patients will have regular check-ups that include imaging scans such as CT scans or MRI scans to see how the tumors are responding to treatment. Blood and stool samples will be collected at various points during the study. Patients will also need to provide a tissue sample from their tumor, either from a previous biopsy or from a new biopsy taken before treatment starts. The study requires that patients have measurable disease that can be tracked using imaging tests, and they must not have received any previous treatment for their advanced cancer, although some prior treatment in earlier stages of the disease is allowed if enough time has passed.

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 procedures

    Before starting treatment, a pregnancy test will be performed if applicable. This test must be completed within 14 days before the first dose of medication.

    Blood and stool samples will be collected at designated times throughout the study.

    A recent tissue sample from the affected area will need to be provided. If a recent sample is not available, a new biopsy may be required before treatment begins.

    Imaging scans such as computerized tomography or magnetic resonance imaging will be performed to document the disease.

  2. Step 2

    Treatment phase with study medications

    Treatment will consist of a combination of three medications: zimberelimab, domvanalimab, and sacituzumab govitecan.

    All three medications will be given through intravenous infusion, which means they will be delivered directly into a vein.

    The specific dosage, frequency, and duration of each medication will be determined by the treatment protocol established for the study.

    Treatment will continue according to the schedule provided by the medical team overseeing the study.

  3. Step 3

    Ongoing monitoring and assessments

    Regular blood tests will be performed to monitor blood cell counts, liver function, and kidney function.

    Imaging scans will be conducted periodically to assess how the disease is responding to treatment. These assessments will follow RECIST version 1.1 criteria, which are standardized methods for measuring tumor size and response.

    Any side effects or changes in health status will be monitored and recorded using the Common Terminology Criteria for Adverse Events version 5.0, a standardized system for describing side effects.

    Blood and stool samples will continue to be collected at the designated time points as specified in the study protocol.

  4. Step 4

    Treatment continuation or completion

    Treatment will continue until the disease progresses, unacceptable side effects occur, or the study protocol determines treatment should stop.

    The medical team will regularly evaluate the response to treatment, including whether the disease has decreased in size, remained stable, or progressed.

    The duration of response, if the disease responds to treatment, will be measured from the first time a response is documented until the disease progresses or other criteria are met.

  5. Step 5

    Post-treatment follow-up period

    After completing treatment with the study medications, follow-up will continue to monitor long-term outcomes.

    If applicable, contraception must be continued for 6 months after the last dose of study medication.

    During this period, egg cell donation, sperm donation, sperm banking, and breastfeeding are not permitted.

    The medical team will continue to track survival and any long-term effects of the treatment.

Who can join the trial?

14 criteria

  • You must be 18 years of age or older, of any race or ethnic group, and able to understand and sign a consent form
  • You must be willing to provide blood and stool samples at specific times during the study
  • If you are a woman who can become pregnant and are sexually active with a male partner, you must have a negative pregnancy test within 14 days before starting treatment. You must also agree to use highly effective birth control from the time of screening until 6 months after the last dose of study treatment. You must not donate eggs or breastfeed during this time
  • If you are a male participant who is sexually active with a woman who can become pregnant, you must be surgically sterile or use acceptable birth control from the time of screening until 6 months after the last dose of study treatment. You must not donate or store sperm during this time
  • You must have an ECOG performance status of 0 to 1, which is a measure of how well you can perform daily activities. A score of 0 means you are fully active, and 1 means you have some restrictions but can still do light work
  • You must have a life expectancy of at least 12 weeks at the time of screening
  • You must have triple-negative breast cancer confirmed by tissue examination. This means your cancer has less than 1% expression of estrogen and progesterone receptors and is negative for a protein called HER2
  • Your cancer must be PD-L1 positive, which means it has a specific protein marker with a score of 10 or higher as measured by a specific test
  • You must have locally advanced or metastatic disease that cannot be removed by surgery, confirmed by CT scan or MRI. This means the cancer has spread and cannot be cured by surgery alone
  • You must have measurable disease according to specific criteria. If a tumor is in an area that was previously treated with radiation, it can only be counted if it has clearly grown since the radiation treatment
  • You must not have received any prior treatment for advanced disease. If you received treatment after diagnosis or before surgery in the past, at least 6 months must have passed between completing that treatment and the cancer coming back
  • You must have adequate bone marrow, liver, and kidney function. This includes having enough white blood cells, platelets, and hemoglobin in your blood, normal liver enzyme levels, normal bilirubin levels, adequate kidney function, and normal blood clotting times
  • Any side effects from previous treatments must have resolved to a mild level, except for hair loss or other side effects that your doctor considers safe
  • You must be willing to provide a tissue sample from where the cancer has spread. If a recent sample is not available, a new biopsy must be taken before starting treatment. If a biopsy cannot be done, your eligibility will be reviewed by the study doctor

Who cannot join the trial?

3 criteria

  • The study document does not list specific reasons why patients cannot participate in this clinical trial
  • If you are interested in this study, the research team will need to review your complete medical history to determine if you are eligible to participate
  • General factors that often prevent participation in cancer studies may include having certain other medical conditions, taking specific medications, or having received certain previous treatments, but these specific details are not provided in the available information
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Investigated drugs

  • Zimberelimab

    is a type of immunotherapy medicine that helps your immune system fight cancer cells. It works by blocking a protein that prevents your immune system from attacking the cancer.

  • Domvanalimab

    is another immunotherapy medicine that also helps boost your immune system's ability to recognize and destroy cancer cells. It works in a different way than zimberelimab to help your body fight the disease.

  • Sacituzumab govitecan

    is a targeted cancer treatment that combines an antibody with a chemotherapy drug. The antibody part finds cancer cells, and then delivers the chemotherapy directly to those cells to kill them while limiting damage to healthy cells.

What is already known about the treatment

  • Zimberelimab

    Zimberelimab is an investigational medication given through intravenous infusion that is currently being studied in clinical trials and is not yet approved for standard medical use. It is being tested as a treatment for PD-L1 positive advanced triple-negative breast cancer, a particularly aggressive form of breast cancer. This medication works by blocking a protein called PD-1 on immune cells, which helps the body's immune system recognize and attack cancer cells more effectively.

  • Domvanalimab

    Domvanalimab is an experimental drug administered by intravenous infusion that is currently under investigation in clinical research and has not received approval for routine clinical practice. It is being evaluated for treating PD-L1 positive advanced triple-negative breast cancer in combination with other medications. The medication functions by blocking a protein called TIGIT on immune cells, which removes a brake on the immune system and allows it to fight cancer cells more aggressively.

  • Sacituzumab Govitecan

    Sacituzumab govitecan is a medication delivered through intravenous infusion that has received approval for treating certain types of breast cancer and is being further studied in clinical trials for PD-L1 positive advanced triple-negative breast cancer. It belongs to a class of drugs called antibody-drug conjugates, which work like a guided missile by attaching to a specific protein on cancer cells and then releasing a chemotherapy drug directly into those cells to destroy them. This targeted approach helps kill cancer cells while potentially reducing damage to healthy tissues compared to traditional chemotherapy.

Investigated diseases

Triple-Negative Breast Cancer – Triple-negative breast cancer is a type of breast cancer where the cancer cells test negative for three specific receptors: estrogen receptors, progesterone receptors, and HER2 protein. This means the cancer does not respond to hormonal therapy or treatments that target HER2. It tends to grow and spread more quickly than other types of breast cancer. The disease can occur at any age but is more common in younger women and those with certain genetic mutations. When the cancer is advanced, it means it has spread beyond the breast to nearby tissues or to distant parts of the body. The term "locally advanced" refers to cancer that has grown into nearby tissues but has not spread to distant organs, while "metastatic" means it has spread to distant parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521489-80-00Protocol codeMEDOPP0653Estimated enrolment25 patientsSponsorMedica Scientia Innovation Research S.L.

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