Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Tyra Biosciences, Inc
Study ID
NCT06995677
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TYRA-300 60mg — DRUG
    Self-administered 60mg dose Oral tablet(s) given daily
  • TYRA-300 50mg — DRUG
    Self-administered 50mg dose Oral tablet(s) given daily
  • TYRA-300 Dose TBD — DRUG
    To Be Determined Dose: Self-administered Oral tablet(s) given daily

Study Details

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

Key Dates

Start date
Jun 27, 2025
Status verified
Feb 2026
Primary completion
Feb 29, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Cohort A (DCA)
    TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
  • Experimental: Dose Cohort B (DCB)
    TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
  • Experimental: Possible Dose Cohort C (DCC)
    To Be Determined- TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

Primary Outcome Measure

To assess the efficacy of TYRA-300 in LG IR-NMIBC participants [ Time Frame: at 3 months ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Urology Centers of AlabamaHomewoodAlabama35209-
Arkansas UrologyLittle RockArkansas72211-
Tri Valley Urology - MurrietaMurrietaCalifornia92562-
Om Research LLCSan DiegoCalifornia92123-
Associated Urological SpecialistsChicago RidgeIllinois60415-
Duly Health and CareLisleIllinois60532-
Urology of IndianaGreenwoodIndiana46143-
First UrologyJeffersonvilleIndiana47130-
University of Kansas Medical Center (KUMC)Kansas CityKansas66160-
Johns Hopkins UniversityBaltimoreMaryland21205-
Greater Boston UrologyPlymouthMassachusetts02360-
Atlantic Health SystemMorristownNew Jersey07960-
New Jersey Urology, LLC (Summit Health - Washington Township)Voorhees TownshipNew Jersey08043-
Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center for Prostate and Urologic CancersNew YorkNew York10065-
Associated Medical Professionals of NYSyracuseNew York13210-
The Bronx Veterans Medical Research Foundation, Inc.The BronxNew York10468-
Duke Cancer InstituteDurhamNorth Carolina27705-
Associate Urologist of North CarolinaRaleighNorth Carolina27612-
Oregon Urology InstituteSpringfieldOhio97477-
MidLantic UrologyBala-CynwydPennsylvania19004-
Keystone Urology SpecialistsLancasterPennsylvania17604-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Lowcounty Urology Clinics, P.A.North CharlestonSouth Carolina29406-
Conrad Pearson-MemphisGermantownTennessee38138-
Urology Associates PCNashvilleTennessee37209-
Urology AustinAustinTexas78759-
Baylor College of MedicineHoustonTexas77030-
Urology San AntonioSan AntonioTexas78229-

Find similar trials in Homewood, AL

By research site
Urology Centers of Alabama· Homewood, ALArkansas Urology· Little Rock, ARTri Valley Urology - Murrieta· Murrieta, CAOm Research LLC· San Diego, CAAssociated Urological Specialists· Chicago Ridge, ILDuly Health and Care· Lisle, IL

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