Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma (SURF303)

October 29, 2026 updated by: Tyra Biosciences, Inc

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Estimated)

285

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou (HEGP)
      • Paris, France, 75013
        • Recruiting
        • Hopital Pitie-Salpetriere
      • Saint-Etienne, France
        • Recruiting
        • CHU de Saint-Etienne - Hopital Bellevue
  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah University Hospital - Ein Kerem
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center
    • Tel Aviv
      • Holon, Tel Aviv, Israel, 5822012
        • Recruiting
        • Edith Wolfson Medical Center
      • Ramat Gan, Tel Aviv, Israel
        • Recruiting
        • Chaim Sheba Medical Center
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
  • Spain
      • Cadiz, Spain, 11009
        • Recruiting
        • Hospital Universitario Puerta del Mar
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politècnic La Fe
  • United States
    • California
      • Loma Linda, California, United States, 92354-3450
        • Recruiting
        • Loma Linda University (LLU) - Loma Linda University Medical Center (LLUM)
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612-9416
        • Recruiting
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Recruiting
        • The Winship Cancer Institute of Emory University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago
      • Lisle, Illinois, United States, 60532
        • Recruiting
        • Duly Health and Care Chicago
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Recruiting
        • Urology of Indiana, LLC
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University (IU) Health Physicians - Urology
      • Jeffersonville, Indiana, United States, 47130
        • Recruiting
        • First Urology
    • Massachusetts
      • Plymouth, Massachusetts, United States, 02360
        • Recruiting
        • Greater Boston Urology - Plymouth Care Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5000
        • Recruiting
        • University of Michigan Health System (UMHS)
      • Royal Oak, Michigan, United States, 48073-0996
        • Recruiting
        • Michigan Healthcare Professionals - William Beaumont University Hospital
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Urology of St. Louis
    • New Jersey
      • Sewell, New Jersey, United States, 08080-2359
        • Recruiting
        • Summit Health - Washington Township
    • New York
      • Albany, New York, United States, 12208-3412
        • Recruiting
        • Albany Medical College
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Associated Medical Professionals of NY, PLLC
    • Ohio
      • Cleveland, Ohio, United States, 44111
        • Recruiting
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210-1280
        • Recruiting
        • The Ohio State University Wexner Medical Center
      • Gahanna, Ohio, United States, 43230
        • Recruiting
        • Central Ohio Urology Group
    • Pennsylvania
      • Radnor, Pennsylvania, United States, 19087
        • Recruiting
        • Penn Medicine Radnor
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464-3771
        • Recruiting
        • Medical University of South Carolina (MUSC)
    • Tennessee
      • Nashville, Tennessee, United States, 37209-4035
        • Recruiting
        • Urology Associates, P C
    • Texas
      • Austin, Texas, United States, 78705-2009
        • Recruiting
        • Urology Austin - Apex Cancer Care - Austin
      • Dallas, Texas, United States, 75235
        • Recruiting
        • The University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Drug Dose Cohort A (DCA) 60mg

Dabogratinib (TYRA-300) monotherapy in Participants
Drug: Dabogratinib (TYRA-300) 60mg

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

Other Names:
  • TYRA-300
Experimental: Study Drug Dose Cohort B (DCB) 80mg

Dabogratinib (TYRA-300) monotherapy in Participants
Drug: Dabogratinib (TYRA-300) 80mg

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

Other Names:
  • TYRA-300

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Complete response (CR) rate
within 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR)
Time Frame: up to 36 months
up to 36 months
Complete Response (proportion of participants who continue to have a CR at 12 and 24 months)
Time Frame: at 12 and 24 months
at 12 and 24 months
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)
Time Frame: at 6 months

Complete Response (CR) rate
at 6 months
Safety and tolerability of dabogratinib
Time Frame: Up to 2 years

Incidence rate and severity of adverse events
Up to 2 years
Rate of renal preservation after treatment with dabogratinib
Time Frame: Up to 2 years

Proportion of participants who did not undergo a nephrectomy or nephroureterectomy
Up to 2 years
Change from unresectable UTUC to resectable UTUC
Time Frame: Up to 2 years

Proportion of participants with unresectable disease at baseline who convert to resectable disease on dabogratinib, as assessed by the Investigator
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tyra Biosciences, Inc

Investigators

  • Study Chair: Doug Warner, Tyra Biosciences, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2025

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

November 2, 2026

Last Update Submitted That Met QC Criteria

October 29, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TYR300-203
  • 2025-523539-20-00 (Ctis)
  • 2025 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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