Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations

ClinicalTrials.gov ID: NCT05544552

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.

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ClinicalTrials.gov public records Last synced Oct 22, 2026, 6:54 AM EDT

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
Lead sponsor: Tyra Biosciences, Inc; Industry
Enrollment: 310 participants

Conditions and interventions

Conditions

Interventions

TYRA-300 Drug

Drug

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 22, 2022 (Actual)
Primary completion: Nov 2026 (Estimated)
Completion: Jun 2027 (Estimated)
Last update posted: Jan 12, 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 12, 2026 · Synced Oct 22, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05544552 live on ClinicalTrials.gov.

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