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Dabogratinib

Phase 2

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

Target and mechanism

Target class-Tinib (Kinase)
ModalitySmall molecule

Also known as Dabogratinib (TYRA-300) 60mg

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment230

FDA Designations

No designations recorded

Clinical trial landscape

Dabogratinib · 1 trial · 1 indication

Phase 2 1
NCT07265947Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial CarcinomaLow Grade Upper Tract Urothelial Carcinoma
RECRUITING230 Analytics
PHASE2RECRUITING
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
Low Grade Upper Tract Urothelial CarcinomaUnlock trial analytics

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 to N/A
SexALL
Healthy VolunteersNo
Study Sites17

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 StatesSpain
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Recent Changes (Last 90 Days)

LOWAug 3, 2026NCT07265947lastUpdatePostDate: changed
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Frequently asked questions about Dabogratinib

What is Dabogratinib used for?

Dabogratinib is an investigational small molecule being studied for the treatment of Low Grade Upper Tract Urothelial Carcinoma, a type of cancer affecting the upper urinary tract. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does Dabogratinib target?

Dabogratinib is a kinase inhibitor, a class of drugs that work by blocking specific enzymes involved in cell signaling and growth. Its exact molecular target has not been disclosed, but as a -tinib, it is designed to interfere with kinase activity relevant to cancer cell proliferation.

Who is developing Dabogratinib?

Dabogratinib is being developed by Tyra Biosciences, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol TYRA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Low Grade Upper Tract Urothelial Carcinoma.

What phase is Dabogratinib in?

Dabogratinib is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received approval from the FDA or other regulatory bodies. The ongoing Phase 2 trial is designed to assess its efficacy and safety in the target patient population.

What clinical trials is Dabogratinib in?

Dabogratinib is being evaluated in a Phase 2A/B clinical trial registered as NCT07265947. This study is recruiting participants with Low Grade Upper Tract Urothelial Carcinoma and aims to enroll approximately 230 patients across sites in the United States and Spain. The trial is controlled but not blinded.

Is Dabogratinib the same as TYRA-300?

Yes, Dabogratinib is also known as TYRA-300, specifically in its 60mg formulation. The drug is being developed under this alternative name in clinical and research contexts, and both names refer to the same investigational compound.