Zongertinib for Cancer in Patients Eligible for Early Access Treatment

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What is this study about?

This clinical trial is being done in people with cancer. The study treatment is BI 1810631, which contains the drug zongertinib. It is taken by mouth as a tablet. The purpose of the study is to learn more about the anti-cancer effect and side effects of this treatment when used for cancer care.

The study follows people who receive the study drug and looks at how the treatment is tolerated over time. Some extra testing of tumor samples or blood samples may be done to look for markers in the cancer, which are small signs that can help explain how the cancer is behaving. These tests are optional and are used for research only.

1 study treatment begins

You start the study by taking zongertinib, which is the study medicine listed as BI 1810631.

The medicine is taken by mouth as a film-coated tablet.

The dose is 120 mg at a time.

The medicine is taken once daily.

The duration of treatment is not specified in the source data.

2 study evaluation of treatment effect and side effects

During the trial, your cancer treatment is checked for anti-tumor activity, which means how well the medicine works against the cancer.

Your toxicity, which means side effects or harm caused by the medicine, is also evaluated.

These checks are part of the study while you are receiving the trial medicine.

3 optional sample testing

Some sample tests may be done if they are chosen for your study participation.

These optional tests may include biomarker analyses, which are tests that look for signs in tumor samples or blood that can help understand the cancer or its response to treatment.

The tests may use fixed tumor samples, fresh tumor samples, or liquid biopsies, which means tests done on a blood sample or other body fluid sample.

The study may also look for pathway activations, which are signs that certain cell processes are active, and resistance mechanisms, which are ways the cancer may stop responding to treatment.

Who Can Join the Study?

Be an adult, meaning 18 years of age or older.
Have a cancer diagnosis confirmed by tissue testing (histologically confirmed means the cancer was proven by examining a sample under a microscope).
Have an ECOG performance status of 0 to 2, which means you must be well enough to do most daily activities, with some possible limitation.
Have acceptable organ function, meaning the body’s major organs must be working well enough for study treatment, including:
- Neutrophils (a type of white blood cell that helps fight infection) must be at least 1.5 x 10^9/L.
- Hemoglobin (the protein in red blood cells that carries oxygen) must be at least 90 g/L.
- Platelets (blood cells that help blood clot) must be at least 75 x 10^9/L, unless you have a blood cancer, where this rule does not apply because low counts may be part of the disease.
- Bilirubin (a substance measured to check liver function) must be no more than 1.5 times the upper limit of normal.
- AST and ALT (liver enzymes, which are proteins that can rise when the liver is irritated or damaged) must be less than 3 times the upper limit of normal, or less than 5 times the upper limit if there are known liver metastases (cancer that has spread to the liver).
- Creatinine (a waste product used to check kidney function) must be no more than 1.5 times the upper limit of normal, or creatinine clearance must be at least 40 mL/min/1.73 m2, which also checks kidney function.
- These blood and organ test requirements must be met without growth factor support (medicine that helps blood cells grow) and without a red blood cell transfusion in the 14 days before screening.
Have measurable or evaluable disease, meaning the cancer must be able to be checked by exam, scans, or lab tests to see whether it changes during treatment.
If treatment choice depends on a molecular target, the tumor must have been tested in an accredited diagnostic laboratory (a certified lab) and must show a potentially actionable variant, meaning a gene change that may help guide treatment.
Be able to understand the study and be willing to sign a written or electronic informed consent, which is the formal agreement to join the study after being told about it.
Be willing and able to follow the study rules and visit schedule.
If the study drug is taken by mouth, be able to swallow and keep oral medicine down and have no known malabsorption syndrome, meaning no known problem that prevents the body from absorbing medicine properly.
If you are a woman who could become pregnant or a man, agree to use effective contraception (reliable birth control such as hormonal methods, barrier methods like condoms, or abstinence) during the study and for 4 months after the last study treatment.
If you are a man, agree not to cause a pregnancy during the study and for 4 months after treatment ends.
If you are a man, even after vasectomy (surgical sterilization), agree to use barrier contraception during treatment and for 4 months after the last dose, or to completely avoid sexual intercourse.

Who Cannot Join the Study?

Any ongoing side effects from previous treatment that are worse than grade 2, except for hair loss or nerve damage that is worse than grade 1. “Grade” means how severe a side effect is, with higher numbers meaning more serious problems.
Receiving any other cancer treatment, such as chemotherapy, biologic treatment, radiation therapy, or hormone treatment not used as replacement therapy, unless the required wash-out period has passed. A wash-out period is the time needed after stopping a treatment before starting the study drug. The required time is at least 2 weeks.
For people with castration-resistant prostate cancer (prostate cancer that keeps growing even when testosterone is lowered), continuing androgen deprivation therapy is allowed, so this is not an exclusion by itself.
Using certain supportive care medicines that may also have anti-cancer effects, such as megestrol acetate or bisphosphonates, unless they were started at least 1 week before joining the study.
Having palliative radiotherapy during the study for symptom relief is not allowed unless it is done after discussion with the study sponsor.
Being pregnant or breastfeeding.
Having active, growing brain metastases, which means cancer that has spread to the brain and is still getting worse. People whose brain metastases were treated before may join only if they are medically stable and have been off steroids for at least 4 weeks before the study starts. Steroids are medicines that reduce swelling and inflammation.
Having serious heart problems before the study, including uncontrolled or painful angina (chest pain from poor blood flow to the heart), uncontrolled irregular heart rhythms, or symptomatic congestive heart failure (heart failure that causes symptoms such as shortness of breath or swelling).
Having a left ventricular ejection fraction below 45%. This is a measure of how well the main pumping chamber of the heart is working.
Having had a stroke, including a transient ischemic attack (TIA) or “mini-stroke,” within 3 months before the first study dose.
Having had an acute myocardial infarction, which means a heart attack, within 3 months before the first study dose.
Having any other serious medical condition that the doctor thinks makes study participation unsafe or unlikely to be followed correctly, including:
- Ongoing or active infection
- Significant uncontrolled high blood pressure
- Drug abuse
- Severe mental illness
- Serious social problems that could prevent following study requirements

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Oulu University Hospital	Oulu	Finland
Pohjois-Savon hyvinvointialue	Kuopio	Finland
Pirkanmaan hyvinvointialue	Tampere	Finland
Vyvwovtuixpuwgri hmuulhmzfztilds	Turku	Finland
Hlcfodnj Uyjwmikgee Cninnww Hwhcgbun	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	02.03.2026

Trial locations

Investigated drugs:

Zongertinib

BI 1810631 (zongertinib) is an oral cancer medicine being tested in this trial. It is taken by mouth as a film-coated tablet and is meant to help slow down or stop the growth of cancer cells. The study is looking at how well it works against cancer and how safe it is for patients.

Investigated diseases:

Neoplasm malignant

Cancer – Cancer is a disease in which abnormal cells begin to grow and divide without normal control. These cells can form a mass called a tumor, or they may spread into nearby tissues and other parts of the body. As the disease progresses, the abnormal cells may continue to multiply, invade surrounding areas, and spread farther from the original site.

Trial ID:

2025-524769-26-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Zongertinib for Cancer in Patients Eligible for Early Access Treatment

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Who Can Join the Study?

Who Cannot Join the Study?