Tyra SURF-301: Phase 1/2 study for patients with urothelial carcinoma and an FGFR3 alteration

What is the Purpose of this Study?

We are doing this study to find out if an investigational drug called TYRA-300 (the study drug) is a safe and effective option for patients with locally advanced/metastatic urothelial cancer and other solid tumors.

What is the Condition Being Studied?

Locally Advanced/Metastatic Urothelial Cancer

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with locally advanced/metastatic urothelial cancer
  • Have a life expectancy >12 weeks
  • Are able to swallow capsules
  • Do not have certain eye conditions, such as uncontrolled glaucoma

For more information about who can join this study, please contact the study team at julia.hurrelbrink@duke.edu.

Age Group

What is Involved?

If you choose to join this study, you will:

  • Take the study drug by mouth daily
  • Have blood draws and give urine samples
  • Have imaging done (CT or MRI)
  • Have eye exams
  • Have heart scans (ECG)
  • Have punch biopsies of your skin, where the study doctor removes a small piece of skin from a numbed area
  • Donate a previous tumor biopsy for research, if available

While receiving the study drug, you will visit the clinic about once a week during the first month, every other week during the following month, then once every 4 weeks. Your participation could last up to 12 months or longer, depending on how you respond to the study drug. The dose of study drug you take will depend on when you join the study.

Study Details

Full Title
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)
Principal Investigator
Instructor in the Department of Medicine
Protocol Number
IRB: PRO00111245
NCT: NCT05544552
Phase I/II
Enrollment Status