Low Grade Upper Tract Urothelial CarcinomaPhase 2SURF303NCT07265947
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
A Phase 2 study testing Dabogratinib (TYRA-300) 60mg and Dabogratinib (TYRA-300) 80mg in people with Low Grade Upper Tract Urothelial Carcinoma, run by Tyra Biosciences, Inc at 36 sites in 4 countries.
Trial summary
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Grade Upper Tract Urothelial Carcinoma
- What is being tested?
- Dabogratinib (TYRA-300) 60mg and Dabogratinib (TYRA-300) 80mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 36 sitesin 4 countries
- Study dates
- 22 Dec 2025to Nov 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
36 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 4 countries
United States25 sites, 25 recruiting
- Recruiting
Albany Medical College
Albany, New York, 12208-3412
- Recruiting
University of Michigan Health System (UMHS)
Ann Arbor, Michigan, 48109-5000
- Recruiting
The Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322-1013
- Recruiting
Urology Austin - Apex Cancer Care - Austin
Austin, Texas, 78705-2009
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44111
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1280
- Recruiting
The University of Texas Southwestern Medical Center
Dallas, Texas, 75235
- Recruiting
Central Ohio Urology Group
Gahanna, Ohio, 43230
- Recruiting
Urology of Indiana, LLC
Greenwood, Indiana, 46143
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Indiana University (IU) Health Physicians - Urology
Indianapolis, Indiana, 46202
- Recruiting
First Urology
Jeffersonville, Indiana, 47130
- Recruiting
Duly Health and Care Chicago
Lisle, Illinois, 60532
- Recruiting
Loma Linda University (LLU) - Loma Linda University Medical Center (LLUM)
Loma Linda, California, 92354-3450
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Medical University of South Carolina (MUSC)
Mt. Pleasant, South Carolina, 29464-3771
- Recruiting
Urology Associates, P C
Nashville, Tennessee, 37209-4035
- Recruiting
Greater Boston Urology - Plymouth Care Center
Plymouth, Massachusetts, 02360
- Recruiting
Penn Medicine Radnor
Radnor, Pennsylvania, 19087
- Recruiting
Michigan Healthcare Professionals - William Beaumont University Hospital
Royal Oak, Michigan, 48073-0996
- Recruiting
Summit Health - Washington Township
Sewell, New Jersey, 08080-2359
- Recruiting
Urology of St. Louis
St Louis, Missouri, 63141
- Recruiting
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 13210
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612-9416
Israel5 sites, 5 recruiting
- Recruiting
Edith Wolfson Medical Center
Holon, Tel Aviv, 5822012
- Recruiting
Hadassah University Hospital - Ein Kerem
Jerusalem
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
- Recruiting
Chaim Sheba Medical Center
Ramat Gan, Tel Aviv
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, Tel Aviv, 6423906
France3 sites, 3 recruiting
- Recruiting
Hopital Pitie-Salpetriere
Paris, 75013
- Recruiting
Hôpital Européen Georges Pompidou (HEGP)
Paris, 75015
- Recruiting
CHU de Saint-Etienne - Hopital Bellevue
Saint-Etienne
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz, 11009
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
About this study
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)
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
Read the 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)
- Being tested
- Dabogratinib (TYRA-300) 60mg, Dabogratinib (TYRA-300) 80mg
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabogratinib (TYRA-300) 60mgDrug
Also called TYRA-300
Self-administered 60mg dose Oral tablet(s) given daily
Dabogratinib (TYRA-300) 80mgDrug
Also called TYRA-300
Self-administered 80mg dose Oral tablet(s) given daily
| Study group | Role | What they receive |
|---|---|---|
| Study Drug Dose Cohort A (DCA) 60mg | Experimental | Dabogratinib (TYRA-300) monotherapy in Participants Receives: Drug: Dabogratinib (TYRA-300) 60mg |
| Study Drug Dose Cohort B (DCB) 80mg | Experimental | Dabogratinib (TYRA-300) monotherapy in Participants Receives: Drug: Dabogratinib (TYRA-300) 80mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Complete Response (CR) rate
Measured: at 6 months
Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR)
Measured: up to 36 months
Complete Response (proportion of participants who continue to have a CR at 12 and 24 months)
Measured: at 12 and 24 months
Safety and tolerability of dabogratinib
Incidence rate and severity of adverse events
Measured: Up to 2 years
Rate of renal preservation after treatment with dabogratinib
Proportion of participants who did not undergo a nephrectomy or nephroureterectomy
Measured: Up to 2 years
Change from unresectable UTUC to resectable UTUC
Proportion of participants with unresectable disease at baseline who convert to resectable disease on dabogratinib, as assessed by the Investigator
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start22 Dec 2025
- Primary completionOct 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Upper Tract Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tyra Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doug Warner, Study chair, Tyra Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265947
- Sponsor's protocol ID
- TYR300-203
- Other IDs
- 2025-523539-20-00, 2025
- Acronym
- SURF303
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07265947
- Acronym / sponsor ID
- SURF303 / TYR300-203
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Tyra Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Drug Dose Cohort A (DCA) 60mg | Experimental | Drug: Dabogratinib (TYRA-300) 60mgDabogratinib (TYRA-300) monotherapy in Participants |
| Study Drug Dose Cohort B (DCB) 80mg | Experimental | Drug: Dabogratinib (TYRA-300) 80mgDabogratinib (TYRA-300) monotherapy in Participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabogratinib (TYRA-300) 60mgAlso: TYRA-300Self-administered 60mg dose Oral tablet(s) given daily | Drug | Study Drug Dose Cohort A (DCA) 60mg |
| Dabogratinib (TYRA-300) 80mgAlso: TYRA-300Self-administered 80mg dose Oral tablet(s) given daily | Drug | Study Drug Dose Cohort B (DCB) 80mg |
Primary outcome
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
6 secondary outcomes
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
Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR)
Time frame: 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
Safety and tolerability of dabogratinib
Time frame: Up to 2 years
Rate of renal preservation after treatment with dabogratinib
Time frame: Up to 2 years
Change from unresectable UTUC to resectable UTUC
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Low Grade Upper Tract Urothelial Carcinoma
Not yet recruitingPhase 2
A Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer
Urinary Bladder Neoplasms, Urologic Neoplasms
RecruitingPhase 1/2
Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis
Low-grade Upper Tract Urothelial Carcinoma
RecruitingPhase 3
A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
Upper Urinary Tract Urothelial Carcinoma, Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doug Warner study chair
Tyra Biosciences, Inc
36 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dabogratinib (TYRA-300) 60mg and Dabogratinib (TYRA-300) 80mg in people with Low Grade Upper Tract Urothelial Carcinoma, run by Tyra Biosciences, Inc at 36 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Israel, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lara Balick (929-792-5633, TyraClinicalTrials@tyra.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.