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

Conditions

• Low Grade Upper Tract Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dabogratinib (TYRA-300) 60mg — DRUG
  Self-administered 60mg dose Oral tablet(s) given daily
• Dabogratinib (TYRA-300) 80mg — DRUG
  Self-administered 80mg dose Oral tablet(s) given daily
• Dabogratinib (TYRA-300) TBD — DRUG
  To be determined: Self-administered Oral tablet(s) given daily

Study Details

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

Key Dates

Start date

Dec 22, 2025

Status verified

Jun 2026

Primary completion

Oct 31, 2030

Completion

Nov 30, 2030

Study Design

Enrollment

230 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Study Drug Dose Cohort A (DCA) 60mg
  Dabogratinib (TYRA-300) monotherapy in Participants
• Experimental: Study Drug Dose Cohort B (DCB) 80mg
  Dabogratinib (TYRA-300) monotherapy in Participants
• Experimental: Possible Study Drug Dose Cohort C (DCC) TBD mg
  Dabogratinib (TYRA-300) monotherapy in Participants

Primary Outcome Measure

To assess the efficacy of Dabogratinib in LG UTUC FGFR3+ participants (proportion of participants with a CR within 6 months out of all LG UTUC FGFR3+ participants) [ Time Frame: within 6 months ]

Central Contacts

• Grace Indyk
  858-356-2323
  [email protected]

Locations (7)

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