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New treatment option for Upper Urinary Tract Urothelial Carcinoma
Official title A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer
ClinicalTrials.gov ID: NCT06774131
What this study is testing
What is UGN-104?
UGN-104 is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for upper urinary tract urothelial carcinoma.
Also referred to as UGN-104 (mitomycin) for pyelocalyceal solution.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO [mitomycin] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.
- Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system, with the following disease characteristics:
- At least 1 measurable papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15 mm. Debulking to ≤ 15 mm is permitted.
- Biopsy taken from at least 1 tumor located above the ureteropelvic junction revealing LG urothelial carcinoma (UC). Patients who have been biopsied...
- Patient should have at least 1 remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm post-biopsy.
You likely can't join if
- UC specific exclusions:
- Patient received Bacillus Calmette-Guérin (BCG) treatment for UC during the 6 months before enrollment.
- The patient has untreated concurrent UC in locations other than the target area (unless treated and resolved during Screening); ie, ureteral and...
- Patient has a history of carcinoma in situ (CIS) in the urinary tract.
- Patient has a history of invasive UC in the past 5 years.
- Patient has a history of HG papillary UC in the urinary tract in the past 2 years.
See the full eligibility criteria
- Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.
- Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system, with the following disease characteristics:
- At least 1 measurable papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15 mm. Debulking to ≤ 15 mm is permitted.
- Biopsy taken from at least 1 tumor located above the ureteropelvic junction revealing LG urothelial carcinoma (UC). Patients who have been biopsied within 8 weeks before Screening for this study and shown to have LG UC...
- Patient should have at least 1 remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm post-biopsy.
- Wash urine cytology sampled from the pyelocalyceal system documenting the absence of high-grade (HG) UC, diagnosed not more than 8 weeks before Screening.
- Patients with bilateral LG-UTUC may be enrolled if at least 1 side meets the for the study and if the other kidney does not require further treatments. (The disease in the other kidney must be completely ablated before...
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status \ 40).
- Patients with life expectancy \> 24 months at time of Screening.
- Patients must have adequate organ and bone marrow function as determined by the following routine laboratory tests:
- Leukocytes ≥ 3,000/μL (≥ 3 × 10\^9/L).
- Absolute neutrophil count ≥ 1,500/μL (≥ 1.5 × 10\^9/L).
- Platelets ≥ 100,000/μL (≥ 100 × 10\^9/L).
- Hemoglobin ≥ 9.0 g/dL.
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
- Alkaline phosphatase ≤ 2.5 × ULN.
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.
- Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis. Note: In case of a symptomatic UTI the patient will be treated with antibiotics and the instillation will be postponed...
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for clinical study participants. Female patients of childbearing potential (defined as premenopausal...
- UC specific exclusions:
- Patient received Bacillus Calmette-Guérin (BCG) treatment for UC during the 6 months before enrollment.
- The patient has untreated concurrent UC in locations other than the target area (unless treated and resolved during Screening); ie, ureteral and lower urinary tract tumors must be completely ablated before entry.
- Patient has a history of carcinoma in situ (CIS) in the urinary tract.
- Patient has a history of invasive UC in the past 5 years.
- Patient has a history of HG papillary UC in the urinary tract in the past 2 years.
- Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the study.
- Any other malignancy diagnosed within 2 years before enrollment with the exception of:
- Basal or squamous cell skin cancers.
- Noninvasive cancer of the cervix.
- Any other cancer deemed to be of low risk for progression or patient morbidity during the study period in the opinion of the investigator.
- Patient with urinary obstruction such that there is an inability to deliver the study treatment to the pyelocalyceal system either via ureteral catheter (retrograde administration) or nephrostomy tube (antegrade...
- Known allergy or sensitivity to any component of the study treatment (including excipients) that in the investigator's opinion cannot be readily managed.
- Patient has an intractable bleeding disorder (eg, coagulation factors deficiencies, Von Willebrand disease).
- Patient is currently receiving any other investigational product, has participated in a research protocol involving administration of an investigational product in the past 30 days, or plans to participate in a research...
- Patient was previously treated with JELMYTO (product code UGN-101) for UTUC.
- Women who are pregnant (positive urine or serum pregnancy test), planning to become pregnant during the study period, or who are breastfeeding are not eligible to enroll.
- Patient has any other medical or mental condition(s) that make(s) his/her participation in the study unadvisable in the opinion of the investigator.
- Where applicable per country regulation, the patient must not be currently committed to an institution by virtue of an order issued by either judicial or administrative authorities.
The study team makes the final eligibility decision.
Where it's taking place
- Homewood, Alabama, United States
- Chandler, Arizona, United States
- Queen Creek, Arizona, United States
- Arkansas City, Arkansas, United States
- Bakersfield, California, United States
- Orange, California, United States
- Aventura, Florida, United States
- Gainesville, Florida, United States
- Hialeah, Florida, United States
- Margate, Florida, United States
- Clive, Iowa, United States
- Omaha, Nebraska, United States
- The Bronx, New York, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Tulsa, Oklahoma, United States
- Hershey, Pennsylvania, United States
- Charleston, South Carolina, United States
- Myrtle Beach, South Carolina, United States
- North Charleston, South Carolina, United States
+ 36 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homewood, Alabama, United States; Chandler, Arizona, United States; Queen Creek, Arizona, United States; Arkansas City, Arkansas, United States; Bakersfield, California, United States; Orange, California, United States and 50 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.