Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
Public ClinicalTrials.gov record NCT05544552. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors.
Study identification
- NCT ID
- NCT05544552
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 310 participants
Conditions and interventions
Conditions
- Locally Advanced Urothelial Carcinoma
- Metastatic Urothelial Carcinoma
- Solid Tumor
- Urothelial Carcinoma
- Solid Tumor, Adult
- Bladder Cancer
- Non-muscle-invasive Bladder Cancer
- FGFR3 Gene Mutation
- FGFR3 Gene Alteration
- Advanced Solid Tumor
- Advanced Urothelial Carcinoma
- Urinary Tract Cancer
- Urinary Tract Tumor
- Urinary Tract Carcinoma
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 21, 2022
- Primary completion
- Oct 31, 2026
- Completion
- May 31, 2027
- Last update posted
- Jan 11, 2026
2022 – 2027
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| UMass Memorial Medical Center | Worchester | Massachusetts | 01655 | — |
| Memorial Sloan Kettering Cancer Center (MSKCC) | New York | New York | 10021 | — |
| Duke Cancer Institute (DCI) - Duke Cancer Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic - Main Campus | Cleveland | Ohio | 44195 | — |
| Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville | Nashville | Tennessee | 37232 | — |
| Seattle Cancer Care Alliance (SCCA) - South Lake Union | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05544552, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 11, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05544552 live on ClinicalTrials.gov.