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Dabogratinib

Phase 2

Low Grade Upper Tract Urothelial Carcinoma | Small molecule | Oncology |Tyra Biosciences, Inc.|Last Updated: Jun 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment230
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07265947Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial CarcinomaPHASE2 RECRUITING 230 — — Dec 22, 2025Nov 1, 2030Jun 3, 20267 United States
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Study Endpoints
Primary Endpoints
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)
within 6 months

Complete response (CR) rate

Secondary Endpoints
To assess the efficacy of Dabogratinib in LG UTUC in all participants (proportion of participants with a CR within 6 months out of all LG UTUC participants)
at 6 months
Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR)
up to 36 months
Complete Response (proportion of participants who continue to have a CR at 12 and 24 months)
at 12 and 24 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Study Drug Dose Cohort A (DCA) 60mgEXPERIMENTALDabogratinib (TYRA-300) monotherapy in Participants
Study Drug Dose Cohort B (DCB) 80mgEXPERIMENTALDabogratinib (TYRA-300) monotherapy in Participants
Possible Study Drug Dose Cohort C (DCC) TBD mgEXPERIMENTALDabogratinib (TYRA-300) monotherapy in Participants
Interventions
NameTypeDescription
Dabogratinib (TYRA-300) 60mgDRUGSelf-administered 60mg dose Oral tablet(s) given daily
Dabogratinib (TYRA-300) 80mgDRUGSelf-administered 80mg dose Oral tablet(s) given daily
Dabogratinib (TYRA-300) TBDDRUGTo be determined: Self-administered Oral tablet(s) given daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

1. Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures 2. Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA 3. At least 5mm of marker lesion left behind 4. Participants must have previous genomic report or...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 3, 2026NCT07265947lastUpdatePostDate: changed
LOWJun 3, 2026NCT07265947lastUpdatePostDate: changed
LOWJun 2, 2026NCT07265947lastUpdatePostDate: changed
LOWJun 2, 2026NCT07265947lastUpdatePostDate: changed
LOWJun 2, 2026NCT07265947lastUpdatePostDate: changed
LOWMay 26, 2026NCT07265947primaryCompletionDate: changed
LOWMay 24, 2026NCT07265947studyFirstPostDate: changed