Charting a Potential
New Course with an Oral Approach for Low-Grade Upper Tract Urothelial Carcinoma

Exploring an investigational, once daily treatment for Low-Grade Upper Tract Urothelial Carcinoma (LG-UTUC)

About the SURF303 study

SURF303 is a Phase 2 clinical trial that is evaluating the efficacy and safety of oral dabogratinib in people with Low-Grade Upper Tract Urothelial Carcinoma (LG-UTUC). It is an open-label, non-placebo study, which means that all participants will receive the study drug. The study is now enrolling in the United States, with more sites opening up around the globe.

Unlike treatments that require installations or procedures in a hospital, oral dabogratinib is an investigational medication that is taken as a once-daily dose.

Up to approximately 230 evaluable participants may be enrolled in this Phase 2 study.

What to Expect –
How the Study Works

The SURF303 study will explore two different doses of dabogratinib, an investigational medication that is taken as a once-daily oral therapy. Participants will be placed at random into one of two dosing arms.

  • Cohort 1 will be 80 mg once a day
  • Cohort 2 will be 60 mg once a day

Who can Join the Study?

Participants must have a confirmed diagnosis of LG-UTUC. Urine and tissue samples collected by a physician may be tested for FGFR3 alterations after a patient is enrolled.

A full list of eligibility criteria may be found here: https://clinicaltrials.gov/study/NCT07265947

What is the Study Measuring?

The main goal of the SURF303 study is to find out whether people can have their LG-UTUC completely disappear within six months after starting treatment, defined as a “complete response.”

The study will also evaluate:

  • How long a response could last, on average
  • How oral dabogratinib is tolerated and any potential side effects

Why This Study Matters

LG-UTUC is a highly-recurrent cancer that affects the upper urinary tract, and can involve the kidney, renal pelvis and ureter. Treatment options are limited and can be burdensome for people who experience high rates of complications, pain and even potential loss of a kidney. Researchers are working to find more effective treatment options that can help people live with greater confidence, peace of mind, and potentially reduce disease recurrence.

FGFR3 is a Frequently Altered Gene in Urologic Cancers

Approximately 85 percent of those living with LG-UTUC have changes, or alterations, in a gene called FGFR3 (short for fibroblast growth factor receptor 3). This gene helps control how cells grow and divide. When it doesn’t work properly, it can cause cells to grow too quickly, leading to cancer. Oral dabogratinib is designed to selectively block FGFR3 activity, potentially helping to stop cancer cells from growing while aiming to spare healthy cells.

Because this is a rare disease with very few treatment options, the hope is to deliver a new precise treatment that is designed to be a kidney sparing option for people living with LG-UTUC.

Study Locations

First Urology

Jeffersonville, Indiana, United States 47130

Urology Associates PC

Nashville, Tennessee, United States 37209

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 SURF303?

  • Patients: Talk to your doctor about whether you might qualify for the SURF303 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 LG-UTUC

We are working to advance SURF303, our clinical study of dabogratinib for LG-UTUC. Please complete this form to receive updates.

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