AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with Low Grade Upper Tract Urothelial Carcinoma (SURF303)

This research study is testing a new drug called dabogratinib (TYRA-300) for a specific type of cancer. This cancer, called low-grade upper tract urothelial carcinoma, affects the tubes that carry urine from your kidneys to your bladder. The study is particularly looking at people whose cancer has a certain genetic change (called an FGFR3 alteration). Researchers want to find out how effective the drug is at making the cancer disappear or shrink, and to check for any side effects. They're also trying to find the best dose to use. This is an ‘open-label’ study, meaning both you and your doctors will know you are receiving the study drug.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Tyra Biosciences Inc.

Enrolment target

Start

28 May 2026

Low Grade Upper Tract Urothelial Carcinoma

What is this study about?

This study is about a type of cancer that affects the upper part of your urinary system, specifically the tubes that carry urine from your kidneys to your bladder. This particular cancer is called low-grade upper tract urothelial carcinoma. Sometimes, this type of cancer has a specific change in its genes, called an FGFR3 alteration, which the new drug, dabogratinib (TYRA-300), is designed to target.

The main goal of this study is to see if dabogratinib can make the cancer completely disappear (what doctors call a 'complete response') within six months. We also want to find the safest and most effective dose of the drug. The study will also look at how long the cancer stays gone and whether the drug can help avoid surgery that removes the kidney or part of the urinary tract.

More importantly, we're carefully watching for any side effects, also known as adverse events, to make sure the drug is safe. We’ll also examine how the drug moves through your body. By understanding these things, we hope to find a better treatment option for people living with this type of cancer.

Key takeaways

Tests a new drug (dabogratinib) for a specific type of urinary tract cancer.
Aims to see if the cancer disappears completely or shrinks within 6 months.
Specifically for people with an FGFR3 genetic change in their cancer.
Researchers are carefully looking for any side effects.
Could help avoid surgery for some patients.
This is an early-stage study to understand the drug better.

Who may be eligible?

This study is for adults, aged 18 or older, who have been diagnosed with low-grade upper tract urothelial carcinoma. Both men and women can take part.

Crucially, your cancer must have a specific genetic change called an FGFR3 alteration. This drug is designed to work for this particular type of cancer.

There will be other medical criteria to ensure the study is safe for you and that the results are clear. Your doctor will be able to check if you meet all the requirements.

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?
Have you been diagnosed with low-grade upper tract urothelial carcinoma?
Have your doctors confirmed that your cancer has an FGFR3 genetic change?
Are you able to attend regular clinic appointments for medical checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study drug, dabogratinib. The study is split into two parts (Phase 2A and Phase 2B). The first part will help doctors decide the best dose to use for the second part of the study. You will have regular visits to the clinic for medical checks, including blood tests and scans, to see how the drug is working and to monitor for any side effects. You'll be closely watched for at least six months, and potentially longer, to see how you respond. The exact number of visits and the full duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available. However, there are also potential risks, as the drug might cause side effects, and it's not guaranteed to work for everyone. The research team will carefully monitor your health and any side effects throughout the study. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Bulgaria
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Unverified
France
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Unverified
Spain

Common questions

What is dabogratinib?

Dabogratinib (TYRA-300) is a new drug being tested to treat a specific type of urinary tract cancer.

What kind of cancer is this study for?

This study is for low-grade upper tract urothelial carcinoma, especially if it has a certain genetic change called an FGFR3 alteration.

What does 'complete response' mean?

A 'complete response' means that scans and tests show no signs of the cancer remaining.

Will I know if I'm getting the drug?

Yes, this is an 'open-label' study, meaning everyone taking part will receive dabogratinib, and you and your doctors will know this.

What if the drug doesn't work for me?

Your doctors will regularly check how you are responding, and your treatment plan will be discussed with you if the drug isn't effective or if you experience significant side effects.