Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Tyra Biosciences, Inc
Study ID
NCT07265947
Phase
PHASE2
Status
Recruiting
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Conditions

  • Low Grade Upper Tract Urothelial Carcinoma

Eligibility Criteria

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

Interventions

  • Dabogratinib (TYRA-300) 60mg — DRUG
    Self-administered 60mg dose Oral tablet(s) given daily
  • Dabogratinib (TYRA-300) 80mg — DRUG
    Self-administered 80mg dose Oral tablet(s) given daily
  • Dabogratinib (TYRA-300) TBD — DRUG
    To be determined: Self-administered Oral tablet(s) given daily

Study Details

A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma

Key Dates

First listed
Dec 5, 2025
Start date
Dec 22, 2025
Status verified
Sep 2026
Primary completion
Oct 31, 2030
Completion
Nov 30, 2030

Study Design

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

Arms

  • Experimental: Study Drug Dose Cohort A (DCA) 60mg
    Dabogratinib (TYRA-300) monotherapy in Participants
  • Experimental: Study Drug Dose Cohort B (DCB) 80mg
    Dabogratinib (TYRA-300) monotherapy in Participants
  • Experimental: Possible Study Drug Dose Cohort C (DCC) TBD mg
    Dabogratinib (TYRA-300) monotherapy in Participants

Primary Outcome Measure

To assess the efficacy of Dabogratinib in LG UTUC FGFR3+ participants (proportion of participants with a CR within 6 months out of all LG UTUC FGFR3+ participants) [ Time Frame: within 6 months ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Moffitt Cancer CenterTampaFlorida33612-9416-
The Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-1013-
Duly Health and Care ChicagoLisleIllinois60532-
Urology of Indiana, LLCGreenwoodIndiana46143-
First UrologyJeffersonvilleIndiana47130-
Greater Boston Urology - Plymouth Care CenterPlymouthMassachusetts02360-
University of Michigan Health System (UMHS)Ann ArborMichigan48109-5000-
Urology of St. LouisSt LouisMissouri63141-
Summit Health - Washington TownshipSewellNew Jersey08080-2359-
Albany Medical CollegeAlbanyNew York12208-3412-
Associated Medical Professionals of NY, PLLCSyracuseNew York13210-
Cleveland ClinicClevelandOhio44111-
Central Ohio Urology GroupGahannaOhio43230-
Penn Medicine RadnorRadnorPennsylvania19087-
Medical University of South Carolina (MUSC)Mt. PleasantSouth Carolina29464-3771-
Urology Associates, P CNashvilleTennessee37209-4035-
Urology Austin - Apex Cancer Care - AustinAustinTexas78705-2009-
The University of Texas Southwestern Medical CenterDallasTexas75235-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAMoffitt Cancer Center· Tampa, FLThe Winship Cancer Institute of Emory University· Atlanta, GADuly Health and Care Chicago· Lisle, ILUrology of Indiana, LLC· Greenwood, INFirst Urology· Jeffersonville, IN