A Multicenter, Open-label Phase 1/2 Study of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors with Activating FGFR3 Gene Alterations (SURF-301)
This research study, called SURF-301, is investigating a new medication called TYRA-300, which is being explored as a treatment for advanced cancers, such as bladder cancer (urothelial carcinoma) and other solid tumors. The study is specifically looking for people whose cancer has a particular genetic change in a gene called FGFR3. It's an early-stage study, split into two main parts. The first part is focused on finding a safe dose of the new drug and understanding any side effects. The second part will then look at how effective the drug is at shrinking tumors or slowing down their growth. This is a multi-centre study, meaning it's happening in different locations, and involves adults aged 18 and over.
At a glance
What is this study about?
This research study is looking into a new medication called TYRA-300. It's designed for people who have advanced cancers, which means their cancer has grown or spread and is harder to treat. Specifically, the study is interested in bladder cancer (sometimes called urothelial carcinoma) and other solid tumors. A key requirement for joining this study is that a person's cancer must have a specific genetic change in something called the FGFR3 gene. Researchers believe this change might make the cancer respond to the new drug.
Since this is a new medicine, the study is being done in phases. The first phase focuses on safety. Doctors will give different doses of TYRA-300 to participants to find out what dose is safe and what side effects might occur over the first 28 days. Once a safe dose is found, the study moves to the second phase. In this phase, doctors will give the drug to more people to see how well it works. They will check if the drug can shrink tumors or stop them from growing.
The overall goal of this study is to see if TYRA-300 could be a helpful new treatment option for people with these specific types of advanced cancers. By understanding how safe the drug is and how well it treats the cancer, doctors can decide if it should be tested in even larger studies in the future. It's important to remember that this is still an early-stage study, and the drug is not yet available outside of clinical trials.
Key takeaways
- This study tests a new drug, TYRA-300, for advanced bladder cancer and other specific solid tumors.
- It's for people whose cancer has a particular FGFR3 gene change.
- The study aims to find a safe dose and see how well the drug shrinks tumors.
- It's an early-stage trial (Phase 1/2) meaning safety and effectiveness are being explored for the first time in people.
- Close medical monitoring and regular check-ups are part of participating.
- You can discuss your eligibility and any questions with your doctor.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. Both men and women are welcome to participate. The most important health requirement is that you have an advanced solid cancer, such as bladder cancer, and tests must show that your cancer has a specific change in its FGFR3 gene.
There will be other detailed health checks to make sure the study is right and safe for you. These might include checking your overall health, other medical conditions you have, and any other treatments you're currently receiving. The study team will review all your medical information carefully to see if you meet all the necessary criteria.
If you think you might be eligible, the best step is to talk to your doctor. They can help you understand if your specific cancer and health profile match what the study is looking for.
- Are you 18 years old or older?
- Do you have advanced bladder cancer or another solid cancer?
- Has your doctor told you that your cancer has an FGFR3 gene change?
- Are you able to attend regular hospital visits for tests and check-ups?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will be given the study drug, TYRA-300. Because this is an early-stage study, there will be frequent visits, especially at the beginning, to monitor your health very closely. During these visits, you can expect to have blood tests, urine tests, physical examinations, and scans (like CT or MRI) to check how the drug is affecting your body and your cancer.
The first month (28 days) will be a key period where doctors will watch very closely for any side effects. After this initial monitoring, the frequency of visits might change, but you will still need regular check-ups throughout your time in the study. The total time you spend in the study will depend on how you respond to the treatment and your overall health, but participation usually involves regular treatment cycles and follow-up for a period of time.
Potential risks and benefits
Locations (3)
- —Spain
- —France
- —Italy
Common questions
What is the FGFR3 gene?
The FGFR3 gene is like an instruction manual in your cells. Sometimes, changes in this gene can make cancer grow. This study is for people whose cancer has a specific change in this gene.
What does 'advanced solid cancer' mean?
'Advanced' means the cancer has grown or spread from where it started. 'Solid cancer' refers to a tumour that forms a lump, like bladder cancer, as opposed to blood cancers like leukaemia.
What is a 'Phase 1/2 study'?
This means it's an early study. Phase 1 focuses on finding a safe dose and checking for side effects. Phase 2 then looks at how well the drug works to treat the cancer.
Will I know if the drug is working?
The study team will regularly perform tests, like scans, to check the size of your tumors. They will discuss these results with you to explain how the treatment is (or isn't) affecting your cancer.
Do I have to pay to be in the study?
Usually, clinical trial drugs and study-related medical care are provided free of charge to participants and funded by the trial. You can confirm all costs with the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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