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Study of BT8009 for Patients with Advanced Breast Cancer with NECTIN4 Amplification

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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 breast cancer known as NECTIN4 Amplified Advanced Breast Cancer. The treatment being tested in this study is called zelenectide pevedotin, which is administered as a solution through an intravenous infusion. The purpose of the study is to evaluate how effective this treatment is in patients with this specific type of breast cancer.

Participants in the study will receive the treatment and be monitored over a period of time to observe any changes in their condition. The study aims to measure the response of the cancer to the treatment, looking for signs of improvement or stability. The treatment will be given in cycles, and the health of the participants will be closely watched by the study team to ensure safety and to gather information on how the treatment affects the cancer.

The study will also collect data on any side effects experienced by participants, as well as other health indicators such as laboratory test results and vital signs. This information will help researchers understand the overall impact of zelenectide pevedotin on patients with NECTIN4 Amplified Advanced Breast Cancer and contribute to the development of new treatment options for this disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the study procedures and provide written consent to participate.

    A series of tests will be conducted to confirm your eligibility, including blood tests and imaging scans. These tests will help ensure that you meet the study criteria.

  2. Step 2

    Treatment administration

    You will receive the study medication, BT8009, through an intravenous infusion. This means the medication will be delivered directly into your bloodstream through a vein.

    The dosage and frequency of the medication will be determined by the study protocol, and you will be informed of the schedule during your visits.

  3. Step 3

    Regular monitoring

    Throughout the study, you will have regular visits to monitor your health and the effects of the medication. These visits will include physical exams, blood tests, and imaging scans.

    The study team will assess your response to the treatment and check for any side effects. It is important to report any new symptoms or concerns during these visits.

  4. Step 4

    Follow-up

    After completing the treatment phase, you will enter a follow-up period. During this time, the study team will continue to monitor your health and collect information on your long-term response to the treatment.

    Follow-up visits will be scheduled at regular intervals, and you will be informed of the specific schedule.

Who can join the trial?

16 criteria

  • Must be at least 18 years old.
  • Must have a type of breast cancer called NECTIN4 Amplified Advanced Breast Cancer.
  • Must have breast cancer that is either recurrent (came back after treatment), unresectable (cannot be removed by surgery), or metastatic (has spread to other parts of the body).
  • Must have a confirmed NECTIN4 gene amplification through a specific test.
  • Must have measurable disease according to specific criteria, meaning the cancer can be measured in size.
  • Must provide a sample of the tumor tissue for testing, if not already provided.
  • Must have a life expectancy of at least 12 weeks.
  • Must have an ECOG Performance Status of 0, 1, or 2, which is a scale used to assess how the disease affects daily living abilities.
  • Must have an oxygen saturation level of at least 93% on room air, which measures how much oxygen is in the blood.
  • Must have adequate organ function, including specific levels for liver and kidney function tests.
  • Must have adequate bone marrow function, which includes certain levels of hemoglobin, neutrophils, and platelets in the blood.
  • If taking blood thinners, must have a stable blood clotting time within a safe range.
  • Women who can become pregnant must have a negative pregnancy test before starting the study.
  • Women and men must agree to use highly effective birth control during the study and for 6.5 months after the last dose of the study drug.
  • Men must agree not to donate sperm during the study and for 6.5 months after the last dose of the study drug. Women must not breastfeed or donate eggs during this time.
  • Must be able to understand the study procedures and agree to participate by signing a consent form.

Who cannot join the trial?

9 criteria

  • Participants cannot join if they have any other type of cancer that is not NECTIN4 Amplified Advanced Breast Cancer.
  • Participants who have had another cancer treatment within the last 4 weeks are not eligible.
  • Individuals with severe heart problems cannot participate.
  • Participants with uncontrolled infections are not allowed to join.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Participants who have had an organ transplant are excluded.
  • Individuals with a history of severe allergic reactions to similar drugs cannot participate.
  • Participants with a known history of drug or alcohol abuse are not eligible.
  • Individuals who are unable to follow the study procedures for any reason are excluded.
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Investigated drugs

Zelenectide Pevedotin is a medication being studied for its potential to treat advanced breast cancer. It is specifically being tested in patients whose tumors have a high level of a protein called NECTIN4. This medication works by targeting and binding to the NECTIN4 protein on cancer cells, which may help to stop the growth of the cancer or even shrink the tumors. The goal of using Zelenectide Pevedotin in this trial is to see how effective it is in improving the condition of patients with this specific type of breast cancer.

What is already known about the treatment

Zelenectide Pevedotin – This medication is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced breast cancer that has a specific genetic feature called NECTIN4 amplification. The main goal of using this medication is to see how well it can shrink tumors in patients with this type of cancer. At the molecular level, zelenectide pevedotin works by targeting and binding to the NECTIN4 protein on cancer cells, delivering a toxic substance that helps kill these cells. It is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy designed to attack cancer cells while minimizing damage to normal cells.

Investigated diseases

NECTIN4 Amplified Advanced Breast Cancer – This is a type of breast cancer characterized by the amplification of the NECTIN4 gene. It involves the uncontrolled growth of breast cells that have an increased number of copies of the NECTIN4 gene. As the disease progresses, these cancerous cells can invade nearby tissues and spread to other parts of the body. The amplification of NECTIN4 may contribute to the aggressiveness of the cancer. This form of breast cancer is considered advanced when it has spread beyond the breast and nearby lymph nodes. The progression of the disease can vary, with some cases showing rapid growth and others progressing more slowly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517868-33-00Protocol codeBT8009, Duravelo-3Estimated enrolment66 patientsSponsorBicycletx Limited

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).