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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTyra Biosciences, Inc

About this trial

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

Eligibility criteria

Qualifiers

Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures

Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA

At least 5mm of marker lesion left behind

Participants must have previous genomic report or archival/fresh tissue in addition to urine sample for retrospective genomic testing

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dabogratinib (TYRA-300) 60mg
  • Dabogratinib (TYRA-300) 80mg
  • Dabogratinib (TYRA-300) TBD

Treatment groups

230 Participants
are divided into 3 treatment groups

Sponsors and collaborators