Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
This research study is for adults aged 18 and over who have advanced cancers that haven't responded well to previous treatments. It's specifically for cancers with changes in a protein called HER2, which can cause cancer to grow. The study is testing a new medicine, zongertinib, to see if it can help by blocking these HER2 changes. Participants will be grouped based on their cancer type, HER2 changes, and the dose of zongertinib they receive. They will take zongertinib daily and have regular check-ups with the study doctors. These visits will help the doctors monitor their health, check the treatment's effect on their tumour, and look for any side effects.
At a glance
What is this study about?
This study is called Beamion PANTUMOR-1 and it's trying to find a new way to help people with advanced cancers. Sometimes, a special protein called HER2 can have changes, or 'alterations,' which can make cancer grow. When this happens, it can be hard to treat. This study is testing a medicine called zongertinib to see if it can block these HER2 changes and help shrink or slow down the cancer.
We know that finding effective treatments for advanced cancers, especially when previous options haven't worked, is really important. This study hopes to add to our understanding and potentially offer a new treatment option for those with HER2-altered cancers. It's a 'Phase 2' study, which means it's testing whether the medicine works and is safe in a larger group of people, after earlier tests have shown promise.
Participants will be placed into groups depending on their specific cancer and HER2 changes. This helps the researchers understand how the medicine works for different types of cancer. Doctors will carefully monitor everyone involved, checking both their health and the effects of the treatment. This will help them learn if zongertinib is a helpful medicine.
Key takeaways
- This study investigates a new drug, zongertinib, for advanced cancers with HER2 changes.
- It's for adults whose previous treatments haven't been fully successful.
- Zongertinib aims to block overactive HER2 proteins, which can drive cancer growth.
- Participants will take the medicine daily and have regular health check-ups.
- The study helps researchers understand if zongertinib is a safe and effective treatment.
- Your health and any side effects will be carefully monitored throughout the study.
Who may be eligible?
To join this study, you need to be an adult aged 18 or older and have an advanced solid tumour (meaning cancer that forms a lump, not blood cancer) that has already been treated at least once for advanced stages, but the treatment wasn't successful. Your cancer must also have specific changes in the HER2 protein, which your doctors would have already identified.
There are also some reasons why you might not be able to join. For example, if you have a certain type of lung cancer (HER2 mutant Non-small cell lung cancer), or if you've had other cancers recently that aren't fully cured (though some very common, treatable cancers might be okay). Also, if you need to take other medicines that would interfere with the study medicine, or if you've had major surgery recently, you might not be able to participate. The study doctor will go through all these details with you.
To help the researchers, you also need to be willing to provide a small sample of your cancer tissue that was taken during a previous surgery or biopsy.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have an advanced solid cancer that has already been treated without full success?
- Has your doctor told you that your cancer has specific HER2 changes?
- Are you willing to provide a small sample of your previous tumour tissue?
- Do you feel you may not benefit from or tolerate other standard cancer treatments?
- Have you not been diagnosed with HER2 mutant Non-small cell lung cancer?
What does participation involve?
If you decide to take part, you'll be given the medicine zongertinib, usually once a day. The exact dose will depend on which group you're in. You can continue taking the medicine for as long as it seems to be helping you and you feel well enough to take it. You'll have regular visits to the study clinic.
During many of these visits, the doctors will check to see how the tumour is responding and if it has spread. At every visit, they will carefully check your overall health and ask about any new feelings or side effects you might be having. These check-ups are very important for your safety and to help the researchers understand how the medicine is working. The study team will explain how often these visits are and what they involve in detail.
Potential risks and benefits
Locations (88)
- Alaska Oncology and Hematology, LLCVerified postcodeAnchorage, United States· Recruiting
- University of Arizona Comprehensive Cancer CenterVerified postcodeTucson, United States· Not yet recruiting
- Precision NextGen OncologyVerified postcodeBeverly Hills, United States· Recruiting
- Scripps Cancer Center Torrey PinesVerified postcodeLa Jolla, United States· Not yet recruiting
- Valkyrie Clinical TrialsVerified postcodeLos Angeles, United States· Recruiting
- Yale University School of MedicineVerified postcodeNew Haven, United States· Recruiting
- BRCR GlobalVerified postcodeTamarac, United States· Recruiting
- Illinois Cancer SpecialistsVerified postcodeArlington Heights, United States· Not yet recruiting
- Community MD Anderson Cancer Center - East Medical OncologyVerified postcodeIndianapolis, United States· Recruiting
- Maryland Oncology Hematology, ColumbiaVerified postcodeColumbia, United States· Not yet recruiting
- Karmanos Cancer InstituteVerified postcodeDetroit, United States· Not yet recruiting
- Presbyterian Healthcare ServicesVerified postcodeAlbuquerque, United States· Not yet recruiting
Common questions
What does 'advanced cancer' mean?
Advanced cancer means the cancer has spread beyond where it started or has come back after treatment. It's sometimes called metastatic cancer.
What are 'HER2 alterations'?
HER2 is a protein that can make cancer cells grow. 'Alterations' mean there are changes in this protein that make it overactive, which can cause cancer to develop or spread.
What is zongertinib?
Zongertinib is a new medicine being tested. It's designed to block the overactive HER2 protein, hopefully stopping cancer cells from growing.
What is a 'Phase 2' study?
Phase 2 means this study is testing if the medicine is effective and safe in a larger group of people, after earlier tests have shown some promising results.
How long will I need to be in the study?
You can stay in the study and take the medicine as long as it's helping you and you are tolerating it well. The study team will discuss this during your appointments.
How to find out more
Boehringer Ingelheim
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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