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Study to Determine the Best Dose of Zongertinib with Trastuzumab Deruxtecan or Trastuzumab Emtansine for Patients with Advanced HER2+ 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

This clinical trial is focused on studying certain types of cancer, specifically HER2-positive metastatic breast cancer and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. These are advanced forms of cancer that have spread to other parts of the body. The study is testing a new treatment approach using a combination of medications. One of the medications being tested is called zongertinib (also known by its code name BI 1810631), which is taken orally as a film-coated tablet. The other medications involved are trastuzumab deruxtecan and trastuzumab emtansine, both of which are given through an intravenous infusion, meaning they are administered directly into the bloodstream.

The purpose of this study is to find a suitable dose of zongertinib when used in combination with either trastuzumab deruxtecan or trastuzumab emtansine, and to see if these combinations can help people with these types of cancer. The study is divided into two main parts. The first part, called Phase Ib, involves gradually increasing the dose of zongertinib to determine the highest dose that can be given safely. The second part, Phase II, aims to find out how effective the treatment is at shrinking tumors or stopping them from growing. Participants will receive the study medications and be monitored for any side effects and how well the treatment is working.

Throughout the study, participants will have regular check-ups and tests to assess their health and the progress of their cancer. The study will help researchers understand the best way to use these medications together and whether they can provide a new treatment option for people with these advanced cancers. The study is expected to continue until 2028, with recruitment starting in 2024.

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

    Joining the study

    Upon joining the study, the patient will begin the treatment process. The study is designed to find a suitable dose of zongertinib in combination with either trastuzumab deruxtecan or trastuzumab emtansine for patients with certain types of cancer that have spread.

  2. Step 2

    Phase Ib: dose escalation

    The initial phase involves determining the safest and most effective dose of zongertinib when used with the other medications. This phase focuses on understanding how the body tolerates the medication and identifying any side effects.

    During this phase, the patient will receive zongertinib orally in the form of a film-coated tablet. The patient will also receive either trastuzumab deruxtecan or trastuzumab emtansine intravenously as a solution for infusion.

    The first 21 days of the treatment cycle are crucial for evaluating the maximum tolerated dose. The dose may be adjusted based on the patient's response and any side effects experienced.

  3. Step 3

    Phase II: dose optimization

    In this phase, the focus shifts to assessing the effectiveness of the treatment in reducing tumor size or slowing its growth. The goal is to find the most effective dose for further development.

    The patient will continue to receive the combination of zongertinib and either trastuzumab deruxtecan or trastuzumab emtansine as determined in the previous phase.

    The patient's response to the treatment will be monitored through regular assessments, including imaging tests to measure tumor size and progression.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient will undergo regular health assessments to monitor the effects of the treatment. This includes checking for any side effects and evaluating the overall health status.

    The patient will also participate in assessments to measure the impact of the treatment on daily life and any changes in symptoms.

  5. Step 5

    End of treatment

    The trial is expected to continue until 2028. The patient will remain in the study until the treatment is completed or until it is determined that the treatment is no longer beneficial.

    At the end of the treatment, the patient will undergo a final assessment to evaluate the overall impact of the treatment on their condition.

Who can join the trial?

7 criteria

  • Patients must be **18 years or older** or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent form.
  • Must have **HER2+ mBC** (metastatic breast cancer) or **mGEAC** (metastatic gastric, esophageal, or gastroesophageal junction adenocarcinoma) that is documented.
  • For dose optimization (Phase II): Patients must provide **tumor tissue** from areas not treated with radiation before the biopsy, if possible, collected through previously stored tissue.
  • Must have documented **progression** of the disease as assessed by the investigator.
  • Must have at least one **measurable lesion** according to RECIST 1.1, which is a standard way to measure how well a tumor responds to treatment.
  • Must have an **ECOG score** of 0 or 1, which means the patient is fully active or has some symptoms but can still carry out light work.
  • Must have **adequate organ function** based on laboratory tests.

Who cannot join the trial?

4 criteria

  • Patients with other types of cancer not specified in the study.
  • Patients who are unable to follow the treatment plan and schedule.
  • Patients who have started other anti-cancer treatments before the study treatment shows results.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

  • Zongertinib (BI 1810631)

    is an oral medication being tested in this trial. It is used in combination with other treatments to help determine the best dose that patients can tolerate. The goal is to find out how safe and effective it is for patients with certain types of advanced cancer, specifically those that are HER2 positive.

  • Trastuzumab Deruxtecan (T-DXd)

    is an intravenous medication used in this trial. It is combined with zongertinib to see how well they work together in treating patients with advanced HER2 positive cancers. This medication is designed to target and attack cancer cells.

  • Trastuzumab Emtansine (T-DM1)

    is another intravenous medication used in combination with zongertinib in this trial. Like T-DXd, it is used to treat patients with advanced HER2 positive cancers. It works by delivering a chemotherapy drug directly to the cancer cells, helping to stop their growth.

What is already known about the treatment

  • Zongertinib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced HER2-positive metastatic breast cancer and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. It is in the dose escalation and optimization phases to determine the safest and most effective dosage. Zongertinib works by targeting specific proteins involved in cancer cell growth, thereby inhibiting tumor progression. It is classified as a targeted therapy, focusing on molecular pathways associated with cancer cell proliferation.

  • Trastuzumab Deruxtecan (T-DXd)

    Administered intravenously, this medication is under investigation for its use in treating HER2-positive metastatic breast cancer and certain types of adenocarcinoma. It is currently in clinical trials to optimize its dosage when combined with other treatments. T-DXd functions by delivering chemotherapy directly to cancer cells, utilizing an antibody-drug conjugate mechanism to target and destroy tumor cells. It is classified as a targeted cancer therapy.

  • Trastuzumab Emtansine (T-DM1)

    This intravenous medication is being evaluated in clinical trials for its potential in treating HER2-positive metastatic breast cancer and specific adenocarcinomas. The trials aim to find the optimal dose when used in combination with other drugs. T-DM1 combines an antibody with a chemotherapy agent, specifically targeting and killing cancer cells while minimizing damage to normal cells. It is part of the targeted therapy class, focusing on specific cancer cell markers.

Investigated diseases

  • Metastatic Gastric Adenocarcinoma

    This is a type of stomach cancer that has spread to other parts of the body. It begins in the glandular cells of the stomach lining and can progress to affect nearby organs and distant sites. As the disease advances, it may cause symptoms like weight loss, stomach pain, and difficulty eating.

  • Esophageal Adenocarcinoma

    This cancer originates in the glandular cells of the esophagus, typically in the lower part. It often develops from a condition called Barrett's esophagus, where the lining of the esophagus changes due to acid reflux. The disease can progress to cause swallowing difficulties and chest pain.

  • Gastroesophageal Junction Adenocarcinoma

    This cancer occurs where the esophagus meets the stomach. It shares characteristics with both gastric and esophageal adenocarcinomas. As it progresses, it may lead to symptoms such as difficulty swallowing and weight loss.

  • Metastatic Breast Cancer

    This is breast cancer that has spread beyond the breast to other parts of the body, such as bones, liver, or lungs. It begins in the breast tissue and can progress to cause symptoms like bone pain, fatigue, and shortness of breath. The disease is considered advanced and requires ongoing management.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509566-38-00Protocol code1479-0012Estimated enrolment633 patientsSponsorBoehringer Ingelheim International GmbH

sourced from the EU Clinical Trials Register and site verification

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