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

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.

Who Can Participate?

Eligibility

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.

What is Involved?

Description

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

Christopher

Hoimes

Protocol Number

PRO00111245

NCT ID

NCT05544552

Phase

I/II

Enrollment Status

Open to Enrollment

ClinicalTrials.gov