A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression (FORTITUDE-301)
This study is looking at a new medicine called bemarituzumab for people with solid tumours (cancers that form solid lumps) that show a specific feature known as FGFR2b overexpression. This means their cancer cells have too much of a certain protein. The study has two main parts. The first part will carefully check for any side effects of the medicine and help doctors find the right dose. The second part will then look to see how well the medicine works at shrinking the tumours or stopping them from growing. We hope to learn if bemarituzumab can be a safe and effective new treatment option for people with these types of cancer.
At a glance
What is this study about?
This research study is testing a new medicine called bemarituzumab. It's designed for people who have solid tumours, which are cancers that form a solid mass, like in the breast, lung, or bowel. The medicine is specifically for cancers that have a particular characteristic called 'FGFR2b overexpression'. This means that the cancer cells have too much of a specific protein on their surface, which can sometimes help the cancer grow. Bemarituzumab works by targeting and blocking this protein.
The study has two main goals. The first goal is to check how safe bemarituzumab is and to find the best dose to give. Doctors will carefully monitor participants for any side effects. The second main goal is to see how effective the medicine is at treating these cancers. This means they will look to see if the medicine can shrink the tumours or stop them from growing larger. Doctors will use scans like CT and MRI to see if the tumours are responding to the treatment.
By doing this study, we hope to find out if bemarituzumab can offer a new and effective treatment option for people whose cancers have this specific FGFR2b overexpression. This could potentially lead to better ways to manage these types of solid tumours in the future.
Key takeaways
- This study is testing a new cancer medicine called bemarituzumab.
- It's for specific solid tumours with a marker called FGFR2b overexpression.
- The study aims to check the medicine's safety and how well it works.
- Participation involves regular clinic visits, blood tests, and scans.
- You can withdraw from the study at any time.
- This research might lead to new treatments for these cancers.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. Both men and women can take part.
Your doctors will need to check if your specific type of solid tumour has 'FGFR2b overexpression'. This is a special characteristic of the cancer that the study drug targets.
There might be other health conditions or treatments that could stop you from joining, as the researchers want to make sure the study is as safe as possible for everyone involved. Your doctor will be able to discuss all the details with you.
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 a solid tumour?
- Has your doctor confirmed your cancer has 'FGFR2b overexpression'?
- Are you able to attend regular clinic appointments for treatment and check-ups?
What does participation involve?
If you decide to take part, you will receive the study medicine, bemarituzumab, either on its own or alongside your usual treatment. You will have regular visits to the clinic to monitor your health and how you are responding to the treatment. These visits will involve blood tests, physical examinations, and scans (like CT or MRI) to check the size of your tumour.
Doctors will carefully watch for any side effects and adjust your treatment if needed. You will also have your sight checked regularly, as this is a new medicine. The total length of your participation will depend on how you respond to the treatment and what your doctors decide is best for you, but there will be ongoing follow-up to ensure your well-being.
Potential risks and benefits
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Common questions
What is a 'solid tumour'?
A solid tumour is a type of cancer that forms a solid mass or lump, unlike blood cancers like leukaemia.
What does 'FGFR2b overexpression' mean?
It means your cancer cells have a lot of a specific protein called FGFR2b on their surface. This study drug is designed to target this protein.
What is bemarituzumab?
Bemarituzumab is a new medicine being tested. It's designed to block the FGFR2b protein on cancer cells.
What's the difference between Phase 1 and Phase 2?
Phase 1 studies mainly check the safety of a new medicine and find the right dose. Phase 2 studies then look to see how well it works.
Will I know if the medicine is working?
Yes, doctors will use scans like CT and MRI to see if your tumour is shrinking or stopping its growth, and they will share this information with 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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