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

NCT07265947
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
285
clinicaltrials.gov
Lead sponsor
Tyra Biosciences, Inc
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Start date
2025-12-22
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Number of sites
32
clinicaltrials.gov

Summary
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
clinicaltrials.gov
Acronym
SURF303
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Short title
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
clinicaltrials.gov
Official title
A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants With Low Grade Upper Tract Urothelial Carcinoma (SURF303)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2030-11-01
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First posted
2025-12-05
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Registry last updated
2026-10-16
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Primary completion date
2030-10-01
clinicaltrials.gov
Start date
2025-12-22
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Participants
285
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Participant count basis
Estimated
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Planned participants
285
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Protocol amendments
1
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Number of sites
32
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Tyra Biosciences, Inc
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07265947
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ClinicalTrials.gov ID
NCT07265947
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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)

    Timeframe: within 6 months

    Complete response (CR) rate

  1. 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)

    Timeframe: at 6 months

    Complete Response (CR) rate

  2. Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR)

    Timeframe: up to 36 months

  3. Complete Response (proportion of participants who continue to have a CR at 12 and 24 months)

    Timeframe: at 12 and 24 months

  4. Safety and tolerability of dabogratinib

    Timeframe: Up to 2 years

    Incidence rate and severity of adverse events

  5. Rate of renal preservation after treatment with dabogratinib

    Timeframe: Up to 2 years

    Proportion of participants who did not undergo a nephrectomy or nephroureterectomy

  6. Change from unresectable UTUC to resectable UTUC

    Timeframe: Up to 2 years

    Proportion of participants with unresectable disease at baseline who convert to resectable disease on dabogratinib, as assessed by the Investigator

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures

  • Confirmed LG UTUC (both favorable and unfavorable) per AUA

  • At least 5mm of marker lesion(s) left behind

  • Identification of marker lesion(s) within 8 weeks prior to randomization (refer to Inclusion Criterion #2)

  • If synchronous NMIBC, NMIBC must be fully resected and low-grade Ta or T1

  • No prior BCG administration within 1 year of date of consent.

  • No intravesical chemotherapy within 8 weeks prior to C1D1 (including UGN-101).

  • No systemic chemotherapy within 3 months prior to C1D1

  • ECOG PS 0-2

  • Pathology consists of pure urothelial carcinoma

  • Adequate bone marrow function:

    i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL

  • Adequate liver function:

    i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN

  • Adequate renal function:

    i. Estimated glomerular filtration rate >30 mL/min ii. Serum Phosphate level ≤ ULN prior to starting treatment iii. International normalized ratio (INR) ≤1.5 × ULN

  • 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 C1D1
  • Treatment with an investigational agent within 30 days or 5 half-lives from C1D1, 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 strong and moderate inhibitors or inducers of CYP3A or inhibitors of P-gp and BCRP transporters (prohibited list of medications)
Sources for eligibility
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  • Loma Linda University (LLU) - Loma Linda University Medical Center (LLUM)Loma Linda, United StatesRecruiting
  • USC Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • The Winship Cancer Institute of Emory UniversityAtlanta, United StatesRecruiting
  • Duly Health and Care ChicagoLisle, United StatesRecruiting
  • Urology of Indiana, LLCGreenwood, United StatesRecruiting
  • Indiana University (IU) Health Physicians - UrologyIndianapolis, United StatesRecruiting
  • First UrologyJeffersonville, United StatesRecruiting
  • Greater Boston Urology - Plymouth Care CenterPlymouth, United StatesRecruiting
  • University of Michigan Health System (UMHS)Ann Arbor, United StatesRecruiting
  • Michigan Healthcare Professionals - William Beaumont University HospitalRoyal Oak, United StatesRecruiting
  • Urology of St. LouisSt Louis, United StatesRecruiting
  • Summit Health - Washington TownshipSewell, United StatesRecruiting
  • Albany Medical CollegeAlbany, United StatesRecruiting
  • Associated Medical Professionals of NY, PLLCSyracuse, United StatesRecruiting
  • Cleveland ClinicCleveland, United StatesRecruiting
  • Central Ohio Urology GroupGahanna, United StatesRecruiting
  • Penn Medicine RadnorRadnor, United StatesRecruiting
  • Medical University of South Carolina (MUSC)Mt. Pleasant, United StatesRecruiting
  • Urology Associates, P CNashville, United StatesRecruiting
  • Urology Austin - Apex Cancer Care - AustinAustin, United StatesRecruiting
  • The University of Texas Southwestern Medical CenterDallas, United StatesRecruiting
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • Hopital Pitie-SalpetriereParis, FranceRecruiting
  • Hôpital Européen Georges Pompidou (HEGP)Paris, FranceRecruiting

And 7 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523539-20-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)