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Study of TYRA-300 in Adults with Low Grade Upper Tract Urothelial Carcinoma to Assess Efficacy and Safety

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at people with Low Grade Upper Tract Urothelial Carcinoma, a type of cancer that starts in the lining of the tubes that carry urine from the kidneys to the bladder. The medication being tested is called dabogratinib, also known by the code TYRA-300. The purpose of the study is to see how well the drug works and how safe it is for patients whose tumors have changes in the FGFR3 gene.

Participants will take the study tablets by mouth each day for several months and will return to the clinic for regular check‑ups, which may include imaging scans and urine tests to watch the cancer and any side effects. A “complete response” means that doctors cannot see any sign of the tumor after treatment. If the cancer was originally considered too large to be removed surgically, doctors will also see whether it becomes small enough for surgery, such as removal of part of the kidney (nephrectomy) or the entire kidney and ureter (nephroureterectomy). The study will continue until the planned treatment period ends or until a decision is made based on the participant’s health.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    After you join the study you receive a unique study identification number.

    Your eligibility is confirmed and you are scheduled for the first baseline assessments.

  2. Step 2

    Baseline assessments

    A physical examination, blood tests, and imaging scans are performed to document the condition of your upper tract urothelial carcinoma before any medication is given.

    Any genetic testing needed to identify FGFR3 altered tumors (tumors with a specific gene change) is also completed.

  3. Step 3

    Start of medication

    You begin taking dabogratinib (identified in the study as TYRA‑300).

    Each dose is a 99 mg tablet taken by mouth (oral use).

    The exact schedule (how often each day) and total length of treatment are defined by the study protocol and will be explained by the study physician.

  4. Step 4

    Ongoing medication administration

    You continue to take the prescribed tablet for the duration specified in the study, which may extend for several months unless the study team decides to stop treatment earlier.

  5. Step 5

    Regular safety monitoring

    You attend clinic visits at regular intervals (for example, every four weeks) where blood samples and other tests are taken to check for side effects and overall health.

    Any adverse events (undesired effects) are recorded and managed according to study guidelines.

  6. Step 6

    Efficacy assessments

    At six months after starting medication, imaging and other tests are performed to determine whether a complete response (no detectable tumor) has been achieved.

    Additional assessments are scheduled at twelve months and twenty‑four months if treatment continues, to evaluate the durability of the response.

  7. Step 7

    End of treatment

    Treatment is stopped either after the predetermined study period or earlier if safety concerns arise or if the study team determines that continuing is not beneficial.

  8. Step 8

    Post‑treatment follow‑up

    After stopping the medication you continue to have periodic visits to monitor your health and to record any long‑term effects.

    These follow‑up visits may continue for up to a year or as directed by the study protocol.

Who can join the trial?

12 criteria

  • Be at least 18 years old, able to understand and sign the informed consent form, and able to follow all study visits and procedures.
  • Have a confirmed diagnosis of low‑grade upper tract urothelial carcinoma (LG UTUC), a type of cancer that starts in the lining of the kidney’s tubes.
  • Have a remaining marker lesion that is at least 5 mm in size after any previous surgery.
  • Provide a previous genetic (genomic) report or a stored or fresh tissue sample, plus a urine sample, so the study can perform retrospective genomic testing for the FGFR3 gene.
  • Have the marker lesion identified within the 8 weeks before being randomly assigned to a treatment group.
  • If you also have bladder cancer that has not invaded the muscle (non‑muscle‑invasive bladder cancer, NMIBC), it must have been completely removed and be classified as low‑grade Ta or T1.
  • Not have received a treatment called BCG (a type of immune therapy) within the past year before signing the consent.
  • Not have had any chemotherapy placed directly into the bladder (intravesical chemotherapy, including the drug UGN‑101) within 8 weeks before the first dose of the study drug.
  • Not have had chemotherapy that travels throughout the body (systemic chemotherapy) within 3 months before the first dose.
  • Have an ECOG performance status of 0 to 2, meaning you are fully active or able to care for yourself but may have some limitations.
  • Pathology (the lab analysis of your tumor) must show a pure form of urothelial carcinoma, meaning the cancer cells are only of the lining type.
  • Show adequate function of the bone marrow (blood‑forming tissue), liver, and kidneys (renal function) based on standard lab tests.

Who cannot join the trial?

14 criteria

  • Any sign of high grade (HG) UTUC – meaning a more aggressive or advanced tumor – makes you ineligible.
  • Having had carcinoma in situ (CIS), which is an early flat cancer that has not invaded deeper tissue, excludes you.
  • A history of cancer that involved the prostatic urethra (the tube inside the prostate) prevents participation.
  • Current or past muscle invasive bladder cancer, where the cancer has grown into the bladder muscle layer, is an exclusion.
  • If you have ever had bladder cancer that spread to the lymph nodes or to other parts of the body (called metastatic cancer), you cannot join.
  • Evidence of other bladder cancer types such as squamous cell carcinoma, adenocarcinoma, undifferentiated carcinoma, or small cell carcinoma disqualifies you.
  • Being on any systemic cancer therapy (treatment that affects the whole body), including cytotoxic (cell‑killing) drugs or immunotherapy, excludes you.
  • Having received pelvic external beam radiotherapy for bladder cancer in the past makes you ineligible.
  • If you have previously taken a drug that blocks FGFR (fibroblast growth factor receptor), you cannot participate.
  • Receiving systemic immunotherapy within the last 6 months (six months before the study starts) is an exclusion.
  • Taking any investigational agent (a drug still being tested) within 30 days or five half‑lives of the study start (whichever is shorter) excludes you; if the drug’s half‑life is unknown, the 30‑day rule applies.
  • Having had an intravesical (delivered directly into the bladder) or intracavitary (delivered into a body cavity) treatment within 8 weeks before the first study day also disqualifies you.
  • Current signs of central serous retinopathy or retinal pigmented epithelial detachment (both are eye conditions that affect the retina) at the baseline exam prevent participation.
  • Needing medications that are known to block or increase the activity of the enzyme CYP3A (a list of prohibited drugs) makes you ineligible.
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Investigated drugs

dabogratinib (TYRA-300-B01) is an experimental oral tablet being studied as a treatment for low‑grade upper tract urothelial carcinoma that has changes in a protein called FGFR3. In this trial, participants take the tablet by mouth to see if the drug can slow tumor growth or shrink the cancer. The study is looking at how well the medicine works and whether it is safe for patients.

What is already known about the treatment

Dabogratinib - Dabogratinib is given as a 99 mg oral tablet that patients swallow with water. It is currently an investigational drug being studied in Phase 2 clinical trials for a rare type of bladder‑related cancer. The medicine is intended for people with low‑grade upper‑tract urothelial carcinoma that has changes in the FGFR3 gene. It works by blocking the FGFR3 protein, a type of receptor that helps cancer cells grow, and is classified as an FGFR‑targeted tyrosine‑kinase inhibitor.

Investigated diseases

Low-Grade Upper Tract Urothelial Carcinoma - It is a cancer that begins in the lining of the kidney pelvis or ureter, which are parts of the urinary system above the bladder. The tumor cells grow slowly and look more like normal cells, which is why it is called low grade. Over time the cancer can spread along the lining of the urinary tract. It may become larger and involve more of the upper urinary tract. In some cases it can extend into nearby tissue. The disease typically shows a gradual increase in size and spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523539-20-00Protocol codeTYR300-203Estimated enrolment234 patientsSponsorTyra Biosciences Inc.

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