A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants With Low Grade Upper Tract Urothelial Carcinoma (SURF303)


Condition: Low Grade Upper Tract Urothelial Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07265947

Sponsor: Tyra Biosciences, Inc

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Exclusion Criteria:

  1. Evidence or any features of high grade (HG) UTUC
  2. History of carcinoma in situ (CIS)
  3. History of prostatic urethral involvement
  4. Current or previous history of muscle invasive bladder cancer
  5. Current or previous history of lymph node positive and/or metastatic bladder cancer
  6. Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder
  7. Currently receiving systemic cancer therapy (cytotoxic or immunotherapy)
  8. Current or prior history of pelvic external beam radiotherapy for bladder cancer
  9. Current or history of receiving a prior FGFR inhibitor
  10. Systemic immunotherapy within 6 months prior to randomization
  11. 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.
  12. Prior treatment with an intravesical or intracavitary agent within 8 weeks of C1D
  13. Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.
  14. Requiring use of medications that are potential inhibitors or inducers of CYP3A (prohibited list of medications)

View trial on ClinicalTrials.gov