Phase 3 Study of UGN-103 for Treating Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Sponsor: UroGen Pharma Ltd.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06331299

Provider View

This clinical trial is testing a new treatment called UGN-103 for patients with low-grade non-muscle invasive bladder cancer. The study aims to evaluate how well this treatment works and its safety when given directly into the bladder.

Patient Parameters

Program Overview

This study is testing a new bladder cancer treatment called UGN-103, which is a special form of UGN-102. The treatment is given directly into the bladder to see if it can effectively treat low-grade non-muscle invasive bladder cancer (LG-NMIBC). The study will take place at multiple centers and will focus on how well the treatment works and its safety.

Description

Patients who qualify for the study will receive UGN-103 once a week for six weeks, totaling six doses. The effectiveness of the treatment will be checked three months after the first dose. Doctors will look for signs of cancer using a camera to examine the bladder, check any remaining or new growths, and analyze urine samples.

If the cancer is not detectable at the three-month check-up, patients will continue in the study and visit the clinic every three months for follow-up checks. They will stay in the study until the cancer returns, worsens, the patient passes away, or until the last patient has been followed for 12 months, whichever happens first.

If the cancer is still present at the three-month check-up, patients will receive standard care as decided by their doctor and have a final study visit.

Eligibility Criteria

Inclusion Criteria

  • Agree to participate and follow the study requirements.
  • Have low-grade non-muscle invasive bladder cancer confirmed by a biopsy.
  • Have had at least one previous episode of non-muscle invasive bladder cancer.
  • Have intermediate-risk cancer, which means:
    • Multiple tumors.
    • A single tumor larger than 3 cm.
    • Early or frequent recurrence of cancer within one year of the current diagnosis.
  • Negative test for high-grade cancer in urine within eight weeks before starting the study.
  • Have good organ and bone marrow function based on blood tests.
  • Expected to live at least as long as the study lasts.
  • Use effective birth control if of childbearing potential, from the start of the study until six months after treatment.

Exclusion Criteria

  • Received BCG treatment for bladder cancer in the past year.
  • Had high-grade bladder cancer in the past two years.
  • Allergic to any part of the study treatment that cannot be managed.
  • Have a urethral stricture that prevents catheter use.
  • Have a history of:
    • Neurogenic bladder.
    • Active urinary retention.
    • Any condition preventing normal urination.
  • Have or had muscle invasive bladder cancer or metastatic cancer.
  • Current tumor stage of T1.
  • Have cancer in the upper urinary tract.
  • Have an active urinary tract infection that cannot be treated before the study.
  • Pregnant or breastfeeding.
  • Have a substance abuse or psychiatric disorder that affects study participation.
  • Had intravesical chemotherapy in the past two years, except a single dose after surgery.
  • Participated in another study with an investigational treatment within 30 days.
  • Previously received UGN-102 in a study.
  • Have another active cancer needing systemic treatment.
  • Have any other significant medical or surgical condition affecting safety or study results.
  • Must not be committed to an institution by legal order.

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