Changing the Tide with an Oral Approach for Bladder Cancer
Exploring the first oral FGFR3-selective inhibitor in clinical development for low-grade intermediate-risk non–muscle invasive bladder cancer (IR-NMIBC)
About the Study
SURF302 is an open-label Phase 2 clinical trial evaluating the investigational medicine dabogratinib (formerly TYRA-300) in people with FGFR3-altered, low-grade intermediate-risk non–muscle invasive bladder (IR-NMIBC) cancer. The study will enroll up to 90 participants at multiple clinical sites, primarily in the United States. Dabogratinib is the only oral FGFR3-selective inhibitor currently in clinical development for IR-NMIBC.
Unlike treatments that require injections or procedures in a hospital, dabogratinib is taken as a once-daily tablet.
What to Expect –
How the Study Works
Participants in SURF302 will be placed into one of the study groups at random to receive either:
- A once-daily tablet taken by mouth of dabogratinib at 50 mg
- A once-daily tablet taken by mouth of dabogratinib at 60 mg
What the Study is Measuring
The main goal of the SURF302 study is to find out whether people can have their bladder cancer completely disappear three months after starting treatment — this is called a complete response.
The study will also look at other important things, such as:
- How long a response could last, on average
- How safe dabogratinib is and how well people tolerate it
Why This Study Matters
People with low-grade intermediate-risk non–muscle invasive bladder (IR-NMIBC) cancer are often treated with surgery to remove visible tumors, followed by medications placed directly into the bladder (called intravesical therapies) to help prevent the cancer from coming back.
Although these treatments can help manage the disease, they can also be time-consuming and uncomfortable. Many patients need multiple procedures, frequent catheterization, and regular visits to their doctor or clinic. These repeated treatments can disrupt daily life and cause anxiety about whether the cancer might return.
Even with today’s available therapies, bladder cancer often comes back, meaning patients may face cycles of treatment and monitoring over many years. Because of this, researchers are working to find better, longer-lasting, and less burdensome treatment options — approaches that can help people live with greater confidence and peace of mind.
The SURF302 study is exploring an investigational oral medicine called dabogratinib, which is designed to target a specific pathway in bladder cancer that may help the disease grow. Unlike treatments that must be placed directly into the bladder, dabogratinib is taken by mouth as a pill, which could make it a more convenient and less invasive option for patients. The goal of the study is to see whether dabogratinib can help eliminate cancer cells, reduce the chance of recurrence, and improve quality of life for people living with low-grade IR-NMIBC.
Study Locations
About Our Sponsor
Tyra Biosciences, Inc. is a clinical-stage biotechnology company based in Carlsbad, CA. At Tyra, we are focused on applying our accelerated small molecule drug discovery engine to develop therapies in targeted oncology and genetically defined conditions.
Interested in SURF302?
- Patients: Talk to your doctor about whether you might qualify for the SURF302 trial.
- Physicians: Refer a patient or find a participating site near you by visiting clinicaltrials.gov or contacting a Tyra study representative at tyraclinicaltrials@tyra.bio.
Together, we can explore a new, targeted treatment option for FGFR3-altered IR-NMIBC
We are working to advance SURF302, our clinical study of dabogratinib for low-grade IR NMIBC. Please complete this form to receive updates.
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