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

NCT07265947 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: TYR300-2032025-523539-20-00
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Low Grade Upper Tract Urothelial Carcinoma

Keywords

Low-grade UTUC; Upper Tract Urothelial Carcinoma; Low Grade Upper Tract Urothelial Carcinoma; FGFR Gene Amplification; FGFR Gene Alteration; FGFR Gene Alterations; FGFR3 Mutation; FGFR3 Mutations; FGFR3 Gene Fusions

Outcome Measures

Primary Outcomes (1)

• 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)

  Complete response (CR) rate

  within 6 months

Secondary Outcomes (6)

• 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

• Safety and tolerability of dabogratinib

  Up to 2 years

• Rate of renal preservation after treatment with dabogratinib

  Up to 2 years

Study Arms (3)

Study Drug Dose Cohort A (DCA) 60mg

EXPERIMENTAL

Dabogratinib (TYRA-300) monotherapy in Participants

Drug: Dabogratinib (TYRA-300) 60mg

Study Drug Dose Cohort B (DCB) 80mg

EXPERIMENTAL

Dabogratinib (TYRA-300) monotherapy in Participants

Drug: Dabogratinib (TYRA-300) 80mg

Possible Study Drug Dose Cohort C (DCC) TBD mg

EXPERIMENTAL

Dabogratinib (TYRA-300) monotherapy in Participants

Drug: Dabogratinib (TYRA-300) TBD

Interventions

Dabogratinib (TYRA-300) 60mg DRUG

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

Also known as: TYRA-300

Study Drug Dose Cohort A (DCA) 60mg

Dabogratinib (TYRA-300) TBD DRUG

To be determined: Self-administered Oral tablet(s) given daily

Also known as: TYRA-300

Possible Study Drug Dose Cohort C (DCC) TBD mg

Dabogratinib (TYRA-300) 80mg DRUG

Self-administered 80mg dose Oral tablet(s) given daily

Also known as: TYRA-300

Study Drug Dose Cohort B (DCB) 80mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Evidence or any features of high grade (HG) UTUC
• History of carcinoma in situ (CIS)
• History of prostatic urethral involvement
• Current or previous history of muscle invasive bladder cancer
• Current or previous history of lymph node positive and/or metastatic bladder cancer
• Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder
• Currently receiving systemic cancer therapy (cytotoxic or immunotherapy)
• Current or prior history of pelvic external beam radiotherapy for bladder cancer
• Current or history of receiving a prior FGFR inhibitor
• Systemic immunotherapy within 6 months prior to randomization
• Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter; compounds with an unknown half-life will be default to 30 days.
• Prior treatment with an intravesical or intracavitary agent within 8 weeks of C1D1.
• Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.
• Requiring use of medications that are potential inhibitors or inducers of CYP3A (prohibited list of medications)

Sponsors & Collaborators

• Tyra Biosciences, Inc: lead

Study Sites (4)

Duly Health and Care Chicago

Lisle, Illinois, 60532, United States

RECRUITING

First Urology

Jeffersonville, Indiana, 47130, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44111, United States

RECRUITING

Urology Associates, P C

Nashville, Tennessee, 37209-4035, United States

RECRUITING

Study Officials

• Erik T. Goluboff, MD, MBA

  Tyra Biosciences, Inc

  STUDY CHAIR

Central Study Contacts

Grace Indyk

CONTACT

858-356-2323; TyraClinicalTrials@tyra.bio

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two doses will be explored in Phase 2A (Dose Cohort A (DCA) 80 mg QD) and Dose Cohort B (DCB) 60 mg QD) in parallel design, enrolled by 1:1 randomization. Once the optimized dose is identified, additional participants may be enrolled at the recommended Phase 2B dose to further investigate the efficacy, safety, PK, and therapeutic activity of dabogratinib prior to the official initiation of Phase 2B enrollment. Up to 130 participants may be enrolled in Phase 2A. In Phase 2B, approximately 100 participants will be enrolled.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 5, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)