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Phase II trial evaluating trastuzumab deruxtecan in patients with HER2‑positive advanced/metastatic 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

The trial focuses on patients whose tumors show an excess of the protein HER2, which can occur in several cancers such as HER2-positive rare cancer, HER2 positive non‑small cell lung cancer, HER-positive non rare tumor type, and HER2 positive bladder cancer. The investigational medicine is trastuzumab deruxtecan, given as a intravenous infusion that delivers the drug directly into a vein.

The purpose of the study is to evaluate how well this therapy works against advanced HER2‑positive cancers that have spread to other parts of the body. Participants will receive the infusion on a regular schedule, usually every few weeks, and will attend clinic visits for routine check‑ups, safety monitoring, and simple questionnaires about how they feel. The overall period of involvement lasts several months, during which doctors will track tumor size, any side effects, and overall health status.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Evaluation

    After joining the trial, you will undergo a baseline evaluation that includes a review of your medical history, a physical examination, laboratory tests, and imaging studies to document the extent of your cancer.

  2. Step 2

    First Dose of Study Drug

    You will receive the study medication, Enhertu, which contains the active substance trastuzumab deruxtecan. The dose is 5.4 mg per kilogram of body weight and is given by intravenous infusion. The infusion is performed in a clinical setting under medical supervision.

  3. Step 3

    Ongoing Treatment Cycles

    Subsequent doses of Enhertu are administered at the same dose of 5.4 mg/kg by intravenous infusion according to the study schedule. Each treatment visit includes the infusion and repeat laboratory tests to monitor your health.

  4. Step 4

    Tumor Assessment at 18 Weeks

    Approximately 18 weeks after the first dose, imaging studies are performed to evaluate the tumor’s response to the treatment. The primary measure is the objective response rate, which indicates how much the tumor has shrunk.

  5. Step 5

    Safety Monitoring and Quality‑of‑Life Questionnaire

    Throughout the trial, you will have regular safety assessments that include laboratory tests and evaluation of side effects using the NCI‑CTCAE grading system. You will also complete the EQ‑5D‑5L questionnaire, which records your overall health and quality of life.

  6. Step 6

    Continuation or Discontinuation of Treatment

    Treatment continues until disease progression, unacceptable toxicity, or the end of the study period, whichever occurs first. Your physician will decide whether to continue or stop the medication based on these criteria.

  7. Step 7

    Follow‑Up After Treatment

    After treatment ends, you will attend follow‑up visits to monitor long‑term outcomes, including overall survival and any delayed side effects. These visits may include additional imaging, laboratory tests, and health questionnaires.

Who can join the trial?

14 criteria

  • Must be at least 18 years old when signing the consent form.
  • Must have a confirmed diagnosis of an advanced (cannot be removed by surgery) or metastatic solid tumor that fits one of the study groups: rare tumors, non‑small cell lung cancer, bladder (urothelial) cancer, or common tumors.
  • Must have tumor cells that show high HER2 activity, proved by a lab test that either shows strong HER2 protein (IHC 3+) or a gene test (RNASeq) indicating high HER2 expression.
  • Must have disease that got worse after receiving at least one standard cancer treatment for the type of tumor you have.
  • Must have tumors that can be measured on scans using the standard criteria called RECIST V1.1.
  • Must have a performance status of ECOG 0‑1, meaning you are fully active or able to do light work but not bedridden.
  • Must have a tumor that can be seen on imaging and safely biopsied more than once using a needle or endoscope.
  • Must have normal blood counts and organ function (bone marrow, liver, kidneys, etc.) based on lab tests done within two weeks before starting the study.
  • Must have waited the required “washout” period after any previous cancer therapy before beginning the study drug.
  • Must have a heart pumping function (LVEF) of at least 50 %, measured by an ultrasound (ECHO) or a MUGA scan within 28 days before the first dose.
  • Women who could become pregnant must have a negative pregnancy test, use reliable birth control from screening until 7 months after the last dose, cannot donate or retrieve eggs, and must not breastfeed during this time; egg freezing can be considered before joining.
  • Men with partners who could become pregnant must use reliable birth control from screening until 4 months after the last dose, cannot donate or freeze sperm during this period, and sperm freezing can be considered before joining.
  • Must read, understand, sign, and date the voluntary informed‑consent form and agree to attend all study visits and follow the study procedures.
  • Must have medical insurance coverage.

Who cannot join the trial?

13 criteria

  • You cannot join the study if you had a heart attack (medical term: myocardial infarction) or have had symptoms of congestive heart failure (a condition where the heart does not pump blood well) classified as moderate to severe (New York Heart Association Class II‑IV) within the past 6 months.
  • You cannot join if an electrocardiogram (ECG) shows a prolonged QT interval (a measurement of the heart’s electrical activity) greater than 470 milliseconds for women or greater than 450 milliseconds for men.
  • You cannot join if you have serious lung problems, such as a history of non‑infectious interstitial lung disease or pneumonitis that needed steroids, current lung inflammation that cannot be ruled out by imaging, a recent (within 3 months) pulmonary embolism (blood clot in the lungs), severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, fluid around the lungs (pleural effusion), autoimmune diseases that affect the lungs (like rheumatoid arthritis, Sjogren’s syndrome, or sarcoidosis), or if you have had an entire lung removed.
  • You cannot join if you have spinal cord compression or active brain metastases (cancer that has spread to the brain) that are untreated, cause symptoms, or require steroids or seizure medicines to control symptoms. Inactive, treated brain metastases may be allowed only if you are symptom‑free, not using steroids or seizure medicines, and at least 2 weeks have passed since any brain radiation.
  • You cannot join if you have had another primary cancer within the past 3 years, except for fully removed non‑melanoma skin cancer, early‑stage disease treated in place, or other solid tumors that were cured.
  • You cannot join if you have had a severe allergic (hypersensitivity) reaction to the study drug, any of its inactive ingredients, or to other monoclonal antibodies (a type of lab‑made protein used as medication).
  • You cannot join if you have an uncontrolled infection that needs intravenous (IV) antibiotics, antivirals, or antifungal medicines.
  • You cannot join if you have an active primary immunodeficiency (a condition where the immune system does not work properly), uncontrolled HIV infection, or active hepatitis B or C infection.
  • You cannot join if you still have side effects from previous cancer treatment that are worse than mild (grade > 1) – except hair loss – unless those side effects are stable, mild‑to‑moderate (grade 2), have not gotten worse for at least 3 months, and are being managed (examples include ongoing nerve tingling or fatigue).
  • You cannot join if you have lingering hormone‑related side effects (grade 1 or 2 endocrine problems) from prior immune checkpoint inhibitor (ICI) therapy, unless the study team decides individually that steroids can be used safely.
  • You cannot join if you have previously received any drug that contains a chemotherapy component targeting topoisomerase I (an enzyme important for DNA replication), including antibody‑drug conjugates.
  • You cannot join if you have a history of substance abuse or any other serious medical condition, such as significant heart disease or mental health problems, that the investigator believes could interfere with your participation or the study results.
  • You cannot join if you are currently pregnant or breastfeeding.
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Investigated drugs

Enhertu is an antibody‑drug conjugate that combines a lab‑made antibody with a chemotherapy‑like agent. The antibody part seeks out and binds to the HER2 protein, which is found in high amounts on some cancer cells. Once attached, the attached drug is released inside the cancer cell, helping to kill it. In this trial, patients with advanced or metastatic cancers that have too much HER2 receive Enhertu through an IV infusion to see how well it can shrink or stop tumor growth.

What is already known about the treatment

Enhertu - This medication is supplied as a powder that is mixed into a solution and given by intravenous infusion. It is an approved antibody‑drug conjugate used for several HER2‑positive cancers and is now being studied in this trial for rare and advanced HER2‑positive tumors. The drug works by using an antibody that finds HER2 on cancer cells and carries a chemotherapy payload that damages the cell’s DNA, leading to cell death. It is classified as a targeted antibody‑drug conjugate therapy.

Investigated diseases

  • HER2-positive rare cancer

    A rare cancer that has excess HER2 protein on its cells. It can start as a small growth and then enlarge over time. The tumor may spread to nearby tissues and to distant parts of the body. HER2 signaling can make the cancer grow faster than similar tumors without this feature.

  • HER2-positive non‑small cell lung cancer

    A type of lung cancer that originates in the larger airways and shows high HER2 levels. It often begins as a small nodule in the lung and can enlarge into a larger mass. The disease may spread to nearby lymph nodes and later to other organs. As it progresses, breathing difficulties can become more noticeable.

  • HER2-positive non‑rare tumor

    A relatively common tumor that overexpresses HER2. It usually starts as a localized growth that can increase in size. The tumor may invade surrounding tissue and travel to distant sites. With advancement, more areas of the body can become involved.

  • HER2-positive bladder cancer

    A bladder cancer that has high HER2 expression. It typically begins as a small lesion on the bladder lining and can grow into deeper layers. The cancer may spread to nearby lymph nodes and eventually to other organs. As it progresses, urinary symptoms may become more pronounced.

Trial detailsLast updated 13 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522058-38-00Protocol codeET-25-148Estimated enrolment200 patientsSponsorCentre Leon Berard

sourced from the EU Clinical Trials Register and site verification

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