Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.
This study is looking at how well a drug called zanidatamab works for people with certain types of advanced cancer, including lung, sarcoma, head and neck, bowel, and womb cancer. The drug targets cancers that have a specific change in the HER2 gene. Zanidatamab is already approved in Europe for bile duct cancer, and earlier research suggests it might also help with other cancers that share this HER2 gene change. Participants will receive zanidatamab through a drip every three weeks and will be closely monitored. The aim is to see if zanidatamab can shrink tumours or stop them from growing, offering a potential new treatment option for those with limited choices.
At a glance
What is this study about?
This study is about an investigational medicine called zanidatamab. Cancers develop when there are changes, or 'alterations', in our genes. One gene that can be affected is called HER2. These HER2 gene changes can be found in various types of cancer, including some lung, bowel, head and neck, sarcoma, and womb cancers.
Zanidatamab is an anti-cancer drug designed to specifically target cancer cells that have these HER2 gene changes. It's already used in Europe to treat a specific type of bile duct cancer. However, early research has shown promising results in a small number of patients with other types of cancer that also have this HER2 gene alteration. This means zanidatamab could potentially be helpful for more people if their cancer has this particular genetic change.
The main goal of this study is to find out how effective zanidatamab is in shrinking tumours or stopping their growth in patients with advanced womb, bowel, head and neck, sarcoma, or lung cancer that have the HER2 gene alteration. Researchers will measure how many patients experience a reduction in their tumour size to understand the drug's benefits.
Key takeaways
- This study is for specific advanced cancers with a HER2 gene change.
- The drug being tested is zanidatamab, given every three weeks.
- It aims to see if zanidatamab can shrink or stabilise tumours.
- Close monitoring for side effects and cancer response will occur.
- Participants must have tried at least one other treatment already.
Who may be eligible?
To join this study, you need to have been diagnosed with certain types of cancer, specifically womb, bowel, head and neck, non-small cell lung cancer, or sarcoma. Your cancer must have a specific change in the HER2 gene, which will be checked by the study doctors.
The study is for adults aged 18 or older whose cancer has progressed after receiving at least one previous treatment, and for whom there are no other standard treatment options available. You also need to be generally well enough to take part in a clinical trial, and doctors will check your blood tests to make sure your vital organs like your liver and heart are working adequately.
Your cancer must be advanced, meaning it cannot be removed by surgery and/or has spread. You must also have tumours that can be measured to track the effects of the treatment. If you've previously had anti-HER2 treatments, you generally need to have completed all standard options before joining this study.
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.
- I have womb, bowel, head and neck, lung (non-small cell), or sarcoma cancer.
- My cancer has a specific 'HER2 gene alteration'.
- My cancer has progressed after previous treatment and there are no other standard options.
- I am 18 years old or older.
- My general health and organ functions are good enough for trial participation.
What does participation involve?
If you join this study, you will receive zanidatamab through a drip into your vein every three weeks. You'll continue treatment for as long as it seems to be helping, meaning your cancer is stable or shrinking. Throughout the treatment, you'll have regular hospital visits for medical check-ups.
During these visits, doctors will closely monitor you for any side effects from zanidatamab and provide treatment if needed. They might also adjust the dose of the drug to make it more tolerable for you. To check how your cancer is responding, you'll have scans like CT or MRI every six weeks for the first 18 months, and then every 12 weeks after that.
After you stop treatment, whether due to side effects or if your cancer starts to grow again, you will continue to be monitored by the hospital. This follow-up will last from one to four years, depending on when you started the study.
Potential risks and benefits
Locations (4)
- Institut de Cancérologie de l'OuestVerified postcodeAngers, France· Active not recruiting
- Chu TimoneVerified postcodeMarseille, France· Recruiting
- Institut de Cancérologie de LorraineVerified postcodeVandœuvre-lès-Nancy, France· Active not recruiting
- Gustave RoussyVerified postcodeVillejuif, France· Recruiting
Common questions
What is the HER2 gene alteration?
It's a specific change in a gene that can make some cancers grow. This study is for cancers that have this particular change.
What is zanidatamab?
It's a drug designed to target and treat cancer cells that have the HER2 gene alteration. It's already used for bile duct cancer.
How will I receive the treatment?
You will receive zanidatamab through a drip into your vein at the hospital, once every three weeks.
How long will I be in the study?
You'll receive treatment for as long as it's helping. After treatment stops, you'll have follow-up monitoring for 1 to 4 years.
Will I have regular check-ups?
Yes, you'll have frequent hospital visits for health checks, side effect monitoring, and scans to see how the cancer is responding.
How to find out more
Céline MAHIER AIT OUKHATAR
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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