RecruitingPhase 2NCT06995677

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)

Sponsor

Tyra Biosciences, Inc

Enrollment

90 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Low-grade NMIBC FGFR Gene Amplification FGFR Gene Alterations FGFR3 Gene Alteration FGFR3 Gene Mutation FGFR3 Gene Fusions

Summary

Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a targeted drug called TYRA-300 in people with low-grade non-muscle-invasive bladder cancer (cancer that is in the lining of the bladder but has not grown into the muscle wall) that has a specific gene mutation called FGFR3. The drug is taken by mouth and placed directly inside the bladder. **You may be eligible if...** - You are 18 or older with confirmed low-grade non-muscle-invasive bladder cancer - Your tumor has an FGFR3 mutation or fusion - Your disease is considered intermediate risk (it has come back, is large, is multifocal, or is T1 grade) - Your liver, kidneys, and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have a history of muscle-invasive or metastatic bladder cancer - You have previously received an FGFR inhibitor drug - You have had pelvic radiation therapy - You have certain eye conditions, uncontrolled heart disease, or high phosphate levels - You are pregnant or planning pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTYRA-300 60mg

Self-administered 60mg dose Oral tablet(s) given daily

DRUGTYRA-300 50mg

Self-administered 50mg dose Oral tablet(s) given daily

DRUGTYRA-300 Dose TBD

To Be Determined Dose: Self-administered Oral tablet(s) given daily

Locations(35)

Urology Centers of Alabama

Homewood, Alabama, United States

Arkansas Urology

Little Rock, Arkansas, United States

Tri Valley Urology - Murrieta

Murrieta, California, United States

Om Research LLC

San Diego, California, United States

Associated Urological Specialists

Chicago Ridge, Illinois, United States

Duly Health and Care

Lisle, Illinois, United States

First Urology

Jeffersonville, Indiana, United States

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, United States

Johns Hopkins University

Baltimore, Maryland, United States

Atlantic Health System

Morristown, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center for Prostate and Urologic Cancers

New York, New York, United States

The Bronx Veterans Medical Research Foundation, Inc.

The Bronx, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

Associate Urologist of North Carolina

Raleigh, North Carolina, United States

Oregon Urology Institute

Springfield, Ohio, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Keystone Urology Specialists

Lancaster, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Lowcounty Urology Clinics, P.A.

North Charleston, South Carolina, United States

Conrad Pearson-Memphis

Germantown, Tennessee, United States

Urology Associates PC

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

Urology San Antonio

San Antonio, Texas, United States

Epworth Freemasons-Victoria Parade

Richmond, Victoria, Australia

Istituti Fisioterapici Ospitalieri (IFO)

Rome, Italy, Italy

Istituto Europeo di Oncologia

Milan, Italy

Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara

Pisa, Italy

ASL Napoli 2 Nord - Ospedale Santa Maria delle Grazie

Pozzuoli, Italy

Centro Médico Teknon

Barcelona, Spain, Spain

Hospital Clínico San Carlos

Madrid, Spain, Spain

Hospital Universitario 12 de Oc

Madrid, Spain, Spain

Hospital Quirón Barcelona

Barcelona, Spain

MD Anderson Cancer Center - Madrid

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

View Full Details on ClinicalTrials.gov

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NCT06995677

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