Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma

Recruiting now · Phase 2

Conditions studied: Low Grade Upper Tract Urothelial Carcinoma

In brief

A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma

Key facts

Study ID

NCT07265947

Run by

Tyra Biosciences, Inc

People needed

230

Starts

2025-12-22

Expected to finish

2030-11-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Evidence or any features of high grade (HG) UTUC
• History of carcinoma in situ (CIS)
• History of prostatic urethral involvement
• Current or previous history of muscle invasive bladder cancer
• Current or previous history of lymph node positive and/or metastatic bladder cancer
• Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder
• Currently receiving systemic cancer therapy (cytotoxic or immunotherapy)
• Current or prior history of pelvic external beam radiotherapy for bladder cancer
• Current or history of receiving a prior FGFR inhibitor
• Systemic immunotherapy within 6 months prior to randomization
• Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter; compounds with an unknown half-life will be default to 30 days.
• Prior treatment with an intravesical or intracavitary agent within 8 weeks of C1D1.
• Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.
• Requiring use of medications that are potential inhibitors or inducers of CYP3A (prohibited list of medications)

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• The Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)
• Duly Health and Care Chicago — Lisle, Illinois, United States (enrolling)
• Urology of Indiana, LLC — Greenwood, Indiana, United States (enrolling)
• First Urology — Jeffersonville, Indiana, United States (enrolling)
• Greater Boston Urology - Plymouth Care Center — Plymouth, Massachusetts, United States (enrolling)
• Urology of St. Louis — St Louis, Missouri, United States (enrolling)
• Summit Health - Washington Township — Sewell, New Jersey, United States (enrolling)
• Albany Medical College — Albany, New York, United States (enrolling)
• Associated Medical Professionals of NY, PLLC — Syracuse, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Central Ohio Urology Group — Gahanna, Ohio, United States (enrolling)
• Penn Medicine Radnor — Radnor, Pennsylvania, United States (enrolling)
• Urology Associates, P C — Nashville, Tennessee, United States (enrolling)
• Urology Austin - Apex Cancer Care - Austin — Austin, Texas, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Hospital Universitario Puerta del Mar — Cadiz, Spain (enrolling)

Full record on ClinicalTrials.gov

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