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Study of zongertinib tablets in patients with advanced solid tumors that have HER2 gene changes

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study focuses on patients with HER2-mutated or overexpressed/amplified solid tumors, which are types of cancer where a specific protein called HER2 is either altered or present in higher amounts than normal. The study will test a new medication called zongertinib (also known as BI 1810631) that is given as a film-coated tablet taken by mouth.

The purpose of this research is to evaluate how well zongertinib works in treating various types of advanced cancers that have changes in the HER2 protein. This is an open-label study, which means all participants will receive the active medication. The medication will be given to patients who have already received at least one previous treatment for their advanced cancer.

During the study, participants will take the medication and be monitored for how their cancer responds to the treatment. The study will also look at how long any improvements last and track any side effects that may occur. Participants will also complete questionnaires about their physical functioning and quality of life during the treatment period, which may last up to 15 months.

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 treatment phase

    You will receive zongertinib (BI 1810631) in the form of film-coated tablets that you take by mouth

    Your cancer must be confirmed to have HER2 alterations (mutations or overexpression) before starting the treatment

    A tissue sample from your tumor will be required to confirm your HER2 status

  2. Step 2

    Treatment monitoring

    Your response to treatment will be regularly assessed through medical examinations

    The medical team will monitor if your tumor is responding to the treatment (objective response)

    Regular checks will be performed to identify any side effects (adverse events) that may occur during treatment

  3. Step 3

    Quality of life assessment

    You will complete quality of life questionnaires about your physical functioning

    These assessments will continue until week 48 of the treatment or until your disease shows progression

  4. Step 4

    Follow-up phase

    Your health status will be monitored to assess how long the treatment response lasts

    The medical team will track how long you remain without disease progression (progression free survival)

    The study will continue until September 2027

Who can join the trial?

10 criteria

  • You must provide written informed consent (agreement to participate) before joining the trial
  • You must be 18 years or older (or above the legal age of consent in your country if it's higher than 18)
  • You must have confirmed HER2-positive cancer, shown by either:
    • Higher than normal levels of HER2 protein
    • Changes (mutations) in the HER2 gene
    • You must provide a tumor tissue sample from a previous biopsy to confirm your HER2 status. The sample must not be from an area that received radiation therapy
    • You must have a solid tumor that is either:
      • Locally advanced and cannot be surgically removed
      • Has spread to other parts of the body (metastatic)
      • You must have received at least one previous treatment for your cancer that has spread
      • Your doctor must determine that you are unlikely to benefit from standard treatments known to extend survival
      • Additional eligibility requirements may apply

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Previous participation in clinical trials within the last 30 days
  • Known allergy or hypersensitivity to zongertinib or similar medications
  • Pregnant or breastfeeding women
  • Active or untreated brain metastases (cancer spread to the brain)
  • Serious heart conditions, including uncontrolled high blood pressure or recent heart attack
  • Severe liver dysfunction (poor liver function)
  • Severe kidney dysfunction (poor kidney function)
  • Active, uncontrolled infections
  • Other active cancers requiring treatment (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Any condition that, in the opinion of the investigator, would interfere with the safe conduct of the study
  • Unable to swallow oral medications
  • Life expectancy less than 12 weeks
  • History of organ transplantation
  • Significant psychological, familial, sociological, or geographical conditions that could interfere with study participation
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Investigated drugs

Zongertinib (also known as BI 1810631) is an oral medication designed to target tumors with HER2 mutations or those that have high levels of HER2 protein. It works by blocking the HER2 signals that help cancer cells grow and spread. This medication is being studied as a treatment for various types of solid tumors that have changes in the HER2 gene or increased amounts of HER2 protein on their surface.

What is already known about the treatment

Zongertinib (BI 1810631) - An oral medication being investigated in clinical trials for the treatment of various solid tumors that have HER2 mutations or overexpression. This targeted therapy belongs to the class of tyrosine kinase inhibitors and works by specifically blocking the HER2 signaling pathway, which plays a crucial role in cancer cell growth and survival. The drug is administered in tablet form and is currently being evaluated in Phase II clinical trials to assess its effectiveness and safety across multiple types of HER2-driven solid tumors. The development of this medication represents a potential new treatment option for patients whose cancers are characterized by HER2 genetic alterations.

Investigated diseases

HER2-mutated or HER2-overexpressed tumors - A group of solid tumors characterized by mutations or increased expression of the HER2 protein on the surface of cancer cells. HER2 (Human Epidermal Growth Factor Receptor 2) is a protein that promotes cell growth and division. When cells have too many HER2 receptors or mutations in the HER2 gene, it can lead to uncontrolled cell growth and tumor formation. These tumors can develop in various organs and tissues of the body. The condition is characterized by abnormal cell multiplication and growth of affected tissue.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510429-14-00Protocol code1479-0009Estimated enrolment497 patientsSponsorBoehringer Ingelheim Espana S.A.

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