NCT07265947

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Tyra Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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)

Conditions

• Low Grade Upper Tract Urothelial Carcinoma

Interventions

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

Timeline

• Start date: 2025-12-22
• Primary completion: 2030-10-01
• Completion: 2030-11-01
• First posted: 2025-12-05
• Last updated: 2026-04-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study