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

September 8, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou (HEGP)
  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah University Hospital - Ein Kerem
    • Tel Aviv
      • Holon, Tel Aviv, Israel, 5822012
        • Recruiting
        • Edith Wolfson Medical Center
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
  • Spain
      • Cadiz, Spain, 11009
        • Recruiting
        • Hospital Universitario Puerta del Mar
  • United States
    • 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
      • Lisle, Illinois, United States, 60532
        • Recruiting
        • Duly Health and Care Chicago
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Recruiting
        • Urology of Indiana, LLC
      • 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)
    • 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
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  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 archival/fresh tissue in addition to urine sample for retrospective genomic testing
  5. Identification of marker lesion(s) within 8 weeks prior to randomization (refer to Inclusion Criterion #2)
  6. If synchronous NMIBC, NMIBC must be fully resected and low-grade Ta or T1
  7. No prior BCG administration within 1 year of date of consent.
  8. No intravesical chemotherapy within 8 weeks prior to C1D1 (including UGN-101).
  9. No systemic chemotherapy within 3 months prior to C1D1
  10. ECOG 0-2
  11. Pathology consists of pure urothelial carcinoma

  12. Adequate bone marrow, liver, and renal function:

    1. i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL
    2. i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN
    3. Estimated glomerular filtration rate >60 mL/min
    4. Serum Phosphate level ≤ ULN prior to starting treatment
    5. International normalized ratio (INR) ≤1.5 × ULN

Exclusion Criteria:

  1. Evidence or any features of high grade (HG) UTUC
  2. History of carcinoma in situ (CIS)
  3. History of prostatic urethral involvement
  4. Current or previous history of muscle invasive bladder cancer
  5. Current or previous history of lymph node positive and/or metastatic bladder cancer
  6. Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder
  7. Currently receiving systemic cancer therapy (cytotoxic or immunotherapy)
  8. Current or prior history of pelvic external beam radiotherapy for bladder cancer
  9. Current or history of receiving a prior FGFR inhibitor
  10. Systemic immunotherapy within 6 months prior to randomization
  11. 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.
  12. Prior treatment with an intravesical or intracavitary agent within 8 weeks of C1D1.
  13. Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.
  14. Requiring use of medications that are potential inhibitors or inducers of CYP3A (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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Experimental: Possible Study Drug Dose Cohort C (DCC) TBD mg
Dabogratinib (TYRA-300) monotherapy in Participants
Drug: Dabogratinib (TYRA-300) TBD
To be determined: Self-administered Oral tablet(s) given daily
Other Names:
  • TYRA-300

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tyra Biosciences, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TYR300-203
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523539-20-00 (Ctis)

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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