Phase 3 Study of UGN-104 for Treating Low-Grade Upper Tract Urothelial Cancer

Sponsor: UroGen Pharma Ltd.

Sponsor score: 60

ClinicalTrials ID:NCT06774131

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, UGN-104, for treating low-grade upper tract urothelial cancer (LG-UTUC). The drug is applied directly to the upper urinary tract to see if it can help control the cancer.

Patient Parameters

Program Overview

The study aims to find out if UGN-104, a new version of an already approved drug, can safely and effectively treat low-grade upper tract urothelial cancer (LG-UTUC). The drug is delivered directly into the upper urinary tract of patients to see if it can help manage the cancer.

Description

Patients who qualify for the study will receive UGN-104 once a week for six weeks. The main goal is to see how many patients have no detectable cancer three months after starting treatment. This will be checked through lab tests and visual exams of the urinary tract. If no cancer is found, patients will enter a follow-up phase where they might receive monthly maintenance doses of UGN-104 for up to 11 months. During this time, patients will visit the clinic every three months for check-ups and will stay in the study for up to 15 months or until the cancer returns or worsens. If cancer is still present after the initial treatment, patients will have completed the study.

Eligibility Criteria

Inclusion Criteria

  • Agree to participate and follow study rules.
  • Have low-grade, non-invasive urothelial cancer in the upper urinary tract, with at least one tumor that can be measured and is 15 mm or smaller.
  • Have had a biopsy showing low-grade cancer within 8 weeks before joining the study.
  • Have at least one remaining tumor of at least 5 mm after biopsy.
  • Have urine tests showing no high-grade cancer within 8 weeks before joining.
  • If cancer is present in both kidneys, one side must meet study criteria and the other side must be treated before starting the study.
  • Be in good general health with a performance status score below 3.
  • Have a life expectancy of more than 24 months.
  • Have adequate organ and bone marrow function based on specific blood tests.
  • Have no active urinary tract infection.
  • Use effective birth control if of childbearing potential, from enrollment through 6 months after treatment.

Exclusion Criteria

  • Have received BCG treatment for cancer within 6 months before joining.
  • Have untreated cancer in other areas of the urinary tract.
  • Have a history of certain types of cancer in the urinary tract.
  • Be receiving or planning to receive systemic chemotherapy during the study.
  • Have had another cancer diagnosed within 2 years before joining, except for certain low-risk cancers.
  • Have urinary obstruction preventing treatment delivery.
  • Have allergies to the study treatment that cannot be managed.
  • Have a bleeding disorder.
  • Be participating in another clinical trial or have done so within the past 30 days.
  • Have been treated with JELMYTO for UTUC before.
  • Be pregnant, planning to become pregnant, or breastfeeding.
  • Have any medical or mental conditions that make participation unadvisable.
  • Be committed to an institution by legal order.

Locations

FACILITYZIPCITYSTATE
Penn State Milton S Hershey Medical Center17033HersheyPennsylvania

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