Actively Recruiting
Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis
Led by Ferring Pharmaceuticals · Updated on 2026-05-08
20
Participants Needed
9
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary purpose of this trial is to evaluate the safety \& tolerability of Nadofaragene Firadenovec in subjects with LG-UTUC. To help with this evaluation, a safety lead-in period will be conducted for the first 6 subjects. Complete response is at 3 or 6 months defined as absence of any UTUC in the renal pelvis.
CONDITIONS
Official Title
Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of signing informed consent
- Able to provide written informed consent
- Biopsy-proven low-grade upper tract urothelial cancer confirmed by pathology within 2 months prior to enrollment
- At least one measurable papillary low-grade tumor (5-15 mm) above the ureteropelvic junction
- Subjects with tumors larger than 15 mm are eligible if downsized endoscopically to 5-15 mm before enrollment
- Willing to be available for at least 18 months after first dosing
- Life expectancy greater than 2 years as judged by the investigator
- Eastern Cooperative Oncology Group (ECOG) status of 2 or less
- Females of reproductive potential must have a negative pregnancy test at entry and agree to use effective contraception during treatment and for 6 months after last dose
- Female participants must be postmenopausal or surgically sterile if not of reproductive potential
- Male subjects with female partners of reproductive potential must be surgically sterile or use condoms plus contraception during treatment and for 3 months after last dose
- Adequate laboratory values including hemoglobin ≥10 g/dL, white blood cells ≥4000/µL, absolute neutrophil count ≥2000/µL, platelet count ≥100,000/µL, INR and aPTT below institutional upper limit of normal, AST, ALT, and total bilirubin ≤1.5 times upper limit of normal, sodium >135 mmol/L, potassium between 3.6 and 5.0 mmol/L
- Estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2 (≥60 mL/min/1.73 m2 for safety lead-in subjects)
You will not qualify if you...
- High-grade cytology or histology of UTUC
- Multifocal UTUC unless ureteral tumors are ablated and total tumor diameter above ureteropelvic junction does not exceed 15 mm
- Bilateral disease unless one renal unit is removed or disease-free by endoscopic ablation (not applicable for safety lead-in)
- Current or past carcinoma in situ or muscle invasive urothelial cancer in the urogenital tract
- Concomitant lower tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra
- History of high-grade papillary urothelial cancer within 2 years before screening
- Previous treatment with mitomycin gel or investigational drugs for UTUC
- Current systemic chemotherapy or immunotherapy for bladder cancer or other malignancies
- Investigational treatment for BCG unresponsive NMIBC or other investigational drugs within 1 month prior to screening
- Retroperitoneal external beam radiotherapy within 5 years prior to screening
- Treatment with adenovirus-based drugs or vaccines within 2 weeks before instillation
- Hypersensitivity to nadofaragene firadenovec, interferon-α2b, or adenovector medications
- Urinary tract infection or bacterial cystitis (can enter trial after treatment)
- Clinically significant unexplained elevated liver or kidney function tests at screening
- Pregnant or breastfeeding women
- Any other significant disease or clinical findings preventing trial entry
- History of malignancy in other organs within 5 years except treated basal or squamous cell skin carcinoma, prior ≤pT2 UTUC after nephroureterectomy (≥24 months), cervical intraepithelial carcinoma without invasion, or prostate cancer under surveillance
- Inability to deliver investigational product to the pyelocaliceal system
- BCG treatment within 6 months before treatment start
- Immunosuppressive therapy within 3 months prior to screening
- Immunocompromised or immunodeficient at screening
- Solitary kidney or eGFR below 60 mL/min/1.73 m2 during safety lead-in period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Mayo Clinic - Scottsdale Arizona
Scottsdale, Arizona, United States, 85054
Actively Recruiting
2
Providence Saint John's Cancer Institute
Santa Monica, California, United States, 90404
Actively Recruiting
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
4
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
Mayo Clinic - Rochester Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
8
Baylor College of Medicine (Houston)
Houston, Texas, United States, 77030
Actively Recruiting
9
MD Anderson Cancer Center - Genitourinary (GU) Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Ferring Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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