C4251003- A Phase 2 Basket Study of Tucatinib in Combination with Trastuzumab in Subjects with Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations.
This research study is investigating a new treatment approach for specific types of advanced cancers. These are cancers that have spread or are difficult to remove completely and are linked to something called 'HER2 alterations.' Participants would have already tried other treatments without success. The study is combining a new medicine called Tucatinib (TUKYSA) with another drug, Trastuzumab (Herceptin), and sometimes other hormone therapies. Doctors want to see if this new combination can shrink tumours or stop them from growing. This is a Phase 2 study, meaning it's focusing on how well the treatment works and its safety in a small group of people.
At a glance
What is this study about?
This study, known by its number C4251003, is a clinical trial that aims to find better ways to treat certain advanced cancers. We're talking about cancers that have either spread to other parts of the body (metastatic) or are in a local area but can't be easily removed by surgery (locally advanced unresectable). Crucially, these cancers are driven by something called 'HER2 alterations.' HER2 is a protein that can make cancer cells grow more quickly.
Patients taking part in this study would have already received other treatments for their cancer that haven't been successful. The main goal is to test a new combination of medicines. This combination includes a drug called Tucatinib (also known as TUKYSA) together with another medicine called Trastuzumab (known as Herceptin). In some cases, other hormone treatments like Fulvestrant (Faslodex or Fulvestrant Mylan) might also be used. The research team wants to see if this combination can cause the cancer to shrink or stop growing.
This is a 'Phase 2' study. This means that researchers are primarily focused on understanding how effective the treatment is at shrinking tumours (this is called the 'objective response rate') and how safe it is. They will also look at how long people respond to the treatment, how long they live without the cancer getting worse (progression-free survival), and overall survival. They will also carefully monitor any side effects to understand how they can be managed.
Key takeaways
- This study is for people with specific advanced cancers linked to 'HER2 alterations'.
- It tests a new combination of medicines: Tucatinib, Trastuzumab, and sometimes Fulvestrant.
- Participants must have tried other treatments that didn't work previously.
- The main goals are to see if the treatment shrinks tumours and to check its safety.
- It's a 'Phase 2' study, focusing on effectiveness and side effects in a smaller group.
- Close medical monitoring is provided throughout the study.
Who may be eligible?
To be considered for this study, you would generally need to be at least 18 years old. Both men and women can potentially take part.
The most important factor for this study is that you have a type of advanced cancer that is linked to 'HER2 alterations.' This means your cancer cells have specific changes in a protein called HER2. Your cancer would also need to be either locally advanced and can't be removed, or it has spread to other parts of your body. Also, you must have already tried other treatments for your cancer that haven't worked as hoped.
There will be other detailed criteria that your doctor will check to make sure the study is a good fit for your specific health situation. This might include your general health, other medical conditions, and previous treatments. It's important to discuss all these details with your doctor.
- Are you 18 years old or older?
- Do you have advanced cancer (spread or cannot be removed)?
- Has your doctor confirmed your cancer has 'HER2 alterations'?
- Have you already received other treatments for your cancer that didn't work well?
- Are you able to attend regular hospital visits and follow study procedures?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive ongoing care and your treatment will be closely monitored by a team of doctors and nurses. You will take the study medicines, which are Tucatinib tablets and regular infusions of Trastuzumab. Depending on your type of cancer, you might also receive injections of Fulvestrant.
You will have regular hospital visits for check-ups, blood tests, and scans to see how your body is responding to the treatment and to keep an eye on any side effects. The study team will track how long you take the medicines, if the dose needs to be adjusted, and if the treatment causes any problems. The total length of your participation will depend on how you respond to the treatment and whether you experience any side effects, but you will be monitored throughout your treatment and for a period after stopping the study medications.
Potential risks and benefits
Locations (3)
- —Germany
- —Belgium
- —Spain
Common questions
What is HER2 and why is it important for this study?
HER2 is a protein that can be found on the surface of some cancer cells. When HER2 is altered, it can cause cancer cells to grow and divide more quickly. This study is testing treatments specifically designed for cancers with these HER2 alterations.
What is a 'Phase 2' study?
A Phase 2 study is a stage of clinical research where doctors are mainly looking at how well a new treatment works and how safe it is in a group of people with a specific condition. It helps to decide if the treatment should move on to larger studies.
What does 'previously treated' mean?
It means that you have already received other treatments for your cancer, such as chemotherapy, radiation, or other targeted therapies, but these treatments were not successful in controlling your cancer.
Will I know if I'm getting the study medicine or a placebo?
This particular study is not using a placebo. Everyone enrolled will receive the study medications (Tucatinib, Trastuzumab, and potentially Fulvestrant) in various combinations as part of the new treatment approach being tested.
What kind of commitment is involved if I join?
If you join, you'll have regular hospital visits for health checks, blood tests, and scans. You'll take study medication as prescribed and report any side effects. The study team will explain the full schedule to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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