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Study on the Long-Term Safety of Sacituzumab Govitecan for Patients with Metastatic Solid Tumors

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 clinical trial is focused on studying the long-term safety of a treatment called sacituzumab govitecan for patients with metastatic solid tumors. Metastatic solid tumors are cancers that have spread from their original site to other parts of the body. The treatment being studied, sacituzumab govitecan, is administered as a solution through an intravenous infusion, which means it is given directly into the bloodstream through a vein.

The purpose of this study is to evaluate how safe sacituzumab govitecan is for patients who are already benefiting from this therapy. Participants in the study will continue to receive the treatment as they have been, and researchers will monitor them over time to see if they experience any side effects or changes in their health. The study will track the percentage of participants who experience any adverse events, serious adverse events, or laboratory abnormalities.

This study is open-label, meaning both the researchers and participants know what treatment is being given. It is a rollover study, which means it includes patients who were already receiving sacituzumab govitecan in a previous study and are continuing to benefit from it. The study aims to provide valuable information about the long-term safety of this treatment for individuals with metastatic solid tumors.

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

    Joining the study

    Participation begins after meeting specific criteria, including being 18 years or older and currently receiving treatment with sacituzumab govitecan in a previous study.

    Participants must continue to benefit from the therapy and meet health requirements, such as a creatinine clearance of at least 30 mL/min.

  2. Step 2

    Treatment administration

    The medication used in this study is Trodelvy, which contains sacituzumab govitecan.

    It is administered as a solution for infusion through an intravenous route.

  3. Step 3

    Monitoring and safety evaluation

    The main objective is to evaluate the long-term safety of the treatment in participants with metastatic solid tumors.

    Participants are monitored for any adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities.

  4. Step 4

    Study duration

    The study is expected to continue until January 11, 2027.

    Participants will remain in the study as long as they continue to benefit from the treatment and meet the study's safety requirements.

Who can join the trial?

5 criteria

  • Participants must be **18 years or older** and able to understand and sign a consent form.
  • Participants must currently be receiving treatment with a medication called **sacituzumab govitecan** as part of a previous study.
  • Participants must continue to benefit from the treatment with **sacituzumab govitecan**.
  • Participants must have a **creatinine clearance** of at least 30 mL/min. This is a measure of how well the kidneys are working.
  • Participants who can have children and are sexually active must agree to use specific methods of **contraception** as outlined in the study guidelines.

Who cannot join the trial?

4 criteria

  • Patients who are not benefiting from the continuation of therapy with the study drug.
  • Patients who have medical conditions other than metastatic solid tumors. Metastatic solid tumors are cancers that have spread from their original location to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means groups that may need special protection or care.
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Investigated drugs

Sacituzumab Govitecan is a medication used in this clinical trial to treat patients with metastatic solid tumors. It is designed to help patients who are already benefiting from its use by continuing the therapy to evaluate its long-term safety. This medication works by targeting specific cancer cells and delivering a chemotherapy agent directly to them, which may help in reducing the size of the tumors or slowing their growth.

What is already known about the treatment

Sacituzumab Govitecan – This medication is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its long-term safety in patients with metastatic solid tumors who are benefiting from its use. Sacituzumab Govitecan is primarily used to treat certain types of advanced cancers, particularly those that have spread to other parts of the body. It works by delivering a chemotherapy drug directly to cancer cells, using an antibody that targets a specific protein on the surface of these cells. This medication is classified as an antibody-drug conjugate, combining targeted therapy with chemotherapy to attack cancer cells more effectively.

Investigated diseases

Metastatic Solid Tumors – Metastatic solid tumors are cancers that have spread from their original site to other parts of the body. These tumors can originate in various organs, such as the breast, lung, or colon, and then metastasize to distant organs like the liver, bones, or brain. The progression involves cancer cells breaking away from the primary tumor, traveling through the bloodstream or lymphatic system, and forming new tumors in other organs. This spread can lead to a range of symptoms depending on the organs affected. The growth and spread of these tumors can disrupt normal organ function and lead to various complications. The nature and impact of metastatic solid tumors can vary widely based on the type of primary cancer and the organs involved.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505336-34-00Protocol codeIMMU-132-14Estimated enrolment25 patientsSponsorGilead Sciences Inc.

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