Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New pill aims to wipe out rare urinary tract cancer without surgery

NCT ID NCT07265947

Disease control Sponsor: Tyra Biosciences, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 20 times

Summary

This study tests a new drug called dabogratinib in 230 adults with a rare, low-grade cancer in the upper part of the urinary tract. The goal is to see if the drug can make the cancer disappear completely within 6 months. Participants take the drug by mouth and are monitored for safety and response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Low-grade upper tract urothelial carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

renal pelvis/ureter urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Low-grade upper tract urothelial carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    26 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Albany Medical College

    RECRUITING

    Albany, New York, 12208-3412, United States

  • Associated Medical Professionals of NY, PLLC

    RECRUITING

    Syracuse, New York, 13210, United States

  • Central Ohio Urology Group

    RECRUITING

    Gahanna, Ohio, 43230, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44111, United States

  • Duly Health and Care Chicago

    RECRUITING

    Lisle, Illinois, 60532, United States

  • Edith Wolfson Medical Center

    RECRUITING

    Holon, Tel Aviv, 5822012, Israel

  • First Urology

    RECRUITING

    Jeffersonville, Indiana, 47130, United States

  • Greater Boston Urology - Plymouth Care Center

    RECRUITING

    Plymouth, Massachusetts, 02360, United States

  • Hadassah University Hospital - Ein Kerem

    RECRUITING

    Jerusalem, Israel

  • Hospital Universitari i Politècnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Puerta del Mar

    RECRUITING

    Cadiz, 11009, Spain

  • Hôpital Européen Georges Pompidou (HEGP)

    RECRUITING

    Paris, 75015, France

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Mt. Pleasant, South Carolina, 29464-3771, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612-9416, United States

  • Penn Medicine Radnor

    RECRUITING

    Radnor, Pennsylvania, 19087, United States

  • Summit Health - Washington Township

    RECRUITING

    Sewell, New Jersey, 08080-2359, United States

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • The University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • The Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322-1013, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Michigan Health System (UMHS)

    RECRUITING

    Ann Arbor, Michigan, 48109-5000, United States

  • Urology Associates, P C

    RECRUITING

    Nashville, Tennessee, 37209-4035, United States

  • Urology Austin - Apex Cancer Care - Austin

    RECRUITING

    Austin, Texas, 78705-2009, United States

  • Urology of Indiana, LLC

    RECRUITING

    Greenwood, Indiana, 46143, United States

  • Urology of St. Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.