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NCT06995677 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
A Phase 2 study of FGFR3 Gene Mutation and FGFR3 Gene Alteration, sponsored by Tyra Biosciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT06995677: Recruiting Phase 2 study of FGFR3 Gene Mutation and FGFR3 Gene Alteration, sponsored by Tyra Biosciences.
NCT06995677 is a Phase 2 study of FGFR3 Gene Mutation and FGFR3 Gene Alteration that is actively recruiting participants, run by Tyra Biosciences. The registered enrollment target is 90 participants, below the 143-participant average among 3 other FGFR3 Gene Mutation trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06995677, a Phase 2 study of FGFR3 Gene Mutation and FGFR3 Gene Alteration, is actively recruiting participants, sponsored by Tyra Biosciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
Primary Outcome
Complete response (CR) rate
Conditions Studied
Interventions
- DRUG TYRA-300 60mg
- DRUG TYRA-300 50mg
- DRUG TYRA-300 Dose TBD
Study Locations (20)
California
- Tri Valley Urology - Murrieta - Murrieta
- Om Research LLC - San Diego
Illinois
- Associated Urological Specialists - Chicago Ridge
- Duly Health and Care - Lisle
New York
- Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center for Prostate and Urologic Cancers - New York
- The Bronx Veterans Medical Research Foundation, Inc. - The Bronx
Pennsylvania
- MidLantic Urology - Bala-Cynwyd
- Keystone Urology Specialists - Lancaster
South Carolina
- Carolina Urologic Research Center - Myrtle Beach
- Lowcounty Urology Clinics, P.A. - North Charleston
Texas
- Baylor College of Medicine - Houston
- Urology San Antonio - San Antonio
Alabama
- Urology Centers of Alabama - Homewood
Arkansas
- Arkansas Urology - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2025-06-27 |
| Est. Completion | 2028-09 |
| Phase | Phase 2 |
What NCT06995677 shows while recruiting
NCT06995677 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 143-participant average among 3 other FGFR3 Gene Mutation trials with a reported enrollment target (37% lower).
The record links to 6 conditions, with FGFR3 Gene Mutation appearing as the primary indexed condition, and to 3 interventions - of which TYRA-300 60mg is the first listed.
NCT06995677 names 20 study sites across 14 states, led by California, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT06995677 about?
NCT06995677 is a clinical study titled "Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer". Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
What is the current status of trial NCT06995677?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2025-06-27. Estimated completion is 2028-09.
What conditions does trial NCT06995677 study?
This clinical trial studies the following conditions: FGFR3 Gene Mutation, FGFR3 Gene Alteration, FGFR Gene Amplification, FGFR Gene Alterations, Low-grade NMIBC.
What interventions are being tested in trial NCT06995677?
The interventions under investigation include: TYRA-300 60mg (DRUG), TYRA-300 50mg (DRUG), TYRA-300 Dose TBD (DRUG).
Who is sponsoring clinical trial NCT06995677?
This trial is sponsored by Tyra Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06995677 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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