Trials / Recruiting
RecruitingNCT06995677
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Tyra Biosciences, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
Detailed description
A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Conditions
- Low-grade NMIBC
- FGFR Gene Amplification
- FGFR Gene Alterations
- FGFR3 Gene Alteration
- FGFR3 Gene Mutation
- FGFR3 Gene Fusions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TYRA-300 60mg | Self-administered 60mg dose Oral tablet(s) given daily |
| DRUG | TYRA-300 50mg | Self-administered 50mg dose Oral tablet(s) given daily |
| DRUG | TYRA-300 Dose TBD | To Be Determined Dose: Self-administered Oral tablet(s) given daily |
Timeline
- Start date
- 2025-06-27
- Primary completion
- 2028-02-01
- Completion
- 2028-09-01
- First posted
- 2025-05-29
- Last updated
- 2026-04-09
Locations
33 sites across 4 countries: United States, Australia, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06995677. Inclusion in this directory is not an endorsement.