Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis

This study is testing a treatment called Nadofaragene Firadenovec for people with low-grade upper tract urothelial carcinoma (LG-UTUC), a type of cancer in the upper urinary tract. The treatment will be given into the renal pelvis (the part of the kidney that collects urine). Researchers want to see how safe Nadofaragene Firadenovec is and if it can make the cancer go away. They will measure side effects for up to 30 months and check for a complete response (no signs of cancer) at 3 or 6 months. To join, you must be at least 18 years old and have LG-UTUC confirmed by a recent biopsy. The study plans to enroll 20 participants, but its current status is unclear.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants, with a safety lead-in period for the first 6 subjects.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be monitored for treatment-emergent adverse events for up to 30 months. Complete response will be checked at 3 or 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis

Recruiting

PHASE1Ages 18+InterventionalTreatment

Ferring Pharmaceuticals

~20 participants

Updated 2026-09-15 on ClinicalTrials.gov

What's tested:Nadofaragene Firadenovec

At a glance

Recruiting sites

9 of 9 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

The number of treatment-emergent adverse events reported by each subject during the trial.

Measured over Up to 30 months

+1 more outcome measured

Conditions

Low-grade Upper Tract Urothelial Carcinoma

NCT06668493

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Baylor College of Medicine (Houston)
Houston, Texasno site contact published
Recruiting
Hospital Tenon, Sorbone University
Paris, Franceno site contact published
Recruiting
Mayo Clinic
Jacksonville, Floridano site contact published
Recruiting
Mayo Clinic - Rochester Minnesota
Rochester, Minnesotano site contact published
Recruiting
Mayo Clinic - Scottsdale Arizona
Scottsdale, Arizonano site contact published
Recruiting
MD Anderson Cancer Center - Genitourinary (GU) Cancer Center
Houston, Texasno site contact published
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New Yorkno site contact published
Recruiting
Providence Saint John's Cancer Institute
Santa Monica, Californiano site contact published
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Global Clinical Compliance · STUDY_DIRECTOR · Ferring Pharmaceuticals

Who to contact

Ferring Pharmaceuticals

[email protected]

1-888-337-7464

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Eligibility criteria

Inclusion

Subjects with low-grade tumour larger than 15 mm will be eligible if endoscopic downsizing of the tumour to 5-15 mm in maximum diameter has been performed before enrolment. 5. Willing to be available for at least 18 months after first dosing. 6. Have life expectancy \>2 years, in the opinion of the investigator. 7. Have an Eastern Cooperative Oncology Group (ECOG) status of 2 or less. 8. Females of reproductive potential must have a negative highly sensitive urine or serum pregnancy test upon entry into this trial and be willing to use highly effective contraception during treatment with the investigational medicinal product (IMP) and for 6 months following the last dose. Otherwise, female subjects must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile. Highly effective methods of contraception include: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, and sexual abstinence. 9. Male subjects with female partners of reproductive potential must be surgically sterile or willing to use a condom in addition to effective contraception in their female partner during treatment with the IMP and for 3 months following the last dose. 10. Adequate laboratory values:

haemoglobin ≥10 g/dL

white blood cells (WBC) ≥4000/μL

absolute neutrophil count (ANC) ≥2000/μL

platelet count ≥100,000/μL

international normalized ratio (INR)\* below institutional upper limit of normal (ULN)

activated partial thromboplastin time (aPTT)\* below institutional ULN

aspartate aminotransferase (AST) ≤1.5 x ULN

alanine aminotransferase (ALT) ≤1.5 x ULN

total bilirubin ≤1.5 x ULN

sodium \>135 mmol/L

potassium between 3.6 and 5.0 mmol/L

Exclusion

High-grade cytology or high-grade histology

Multi-focal UTUC

Exception: Subjects with low-grade multi-focal tumours will be eligible if any ureteral tumours can be ablated before enrolment and if the total diameter of the multifocal tumours above the ureteropelvic junction is not exceeding 15 mm in diameter.

Bilateral disease

Exception: Subjects who have had bilateral disease are eligible (not in the safety lead-in) if one renal unit is removed or rendered disease-free by endoscopic ablation before enrolment. 2. Current or previous evidence of carcinoma in situ, of muscle invasive (muscularis propria) urothelial cancer in the urogenital tract presented at the screening visit. 3. Concomitant lower tract urothelial carcinoma and/or concomitant or prior urothelial carcinoma within the prostatic urethra. 4. History of high grade papillary urothelial cancer within 2 years prior to screening. 5. Current or prior treatment with mitomycin gel and/or any investigational drug for the treatment of UTUC. 6. Current systemic chemo- or immunotherapy for bladder cancer or any other malignancy. 7. Current or prior investigational treatment for Bacillus Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) or any other investigational drug within 1 month prior to screening. 8. Current or prior retroperitoneal external beam radiotherapy within 5 years of screening. 9. Prior treatment with adenovirus-based drugs including use of other adenovirus vector medications, including COVID-19 vaccines, within 2 weeks before instillation. 10. Suspected and/or a medical history of hypersensitivity to nadofaragene firadenovec, interferon-α2b (IFN-α2b) and/or adenovector medications. 11. Urinary tract infection or bacterial cystitis (once satisfactorily treated, subjects can enter the trial). 12. Clinically significant and unexplained elevated liver or renal function tests at screening. 13. Women who are pregnant (highly sensitive urine or serum pregnancy test at screening) or breastfeeding. 14. Any other significant disease or other clinical findings which in the opinion of the investigator would prevent trial entry. 15. History of malignancy in any other organ system than the upper urinary tract within the past 5 years prior to screening. However, subjects with the following exceptions will be allowed inclusion in the trial:

Treated basal cell carcinoma or squamous cell carcinoma of the skin.

History of ≤pT2 upper tract urothelial carcinoma, at least 24 months after radical nephroureterectomy (RNU).

Cervical intraepithelial carcinoma (CIN) without evidence of invasive carcinoma.

Prostate cancer that is under active surveillance or urothelial cancer. All other genitourinary cancers are excluded. 16. Inability to deliver IMP to the pyelocaliceal system. 17. Previous BCG treatment during 6 months before the initiation of treatment. 18. Any immunosuppressive therapy within 3 months prior to screening. 19. Subjects who are immunocompromised or immunodeficient at screening. 20. Subjects with solitary kidney and/or an eGFR \<60 mL/min/1.73 m2 (only applicable for subjects in the safety lead-in period).

What this trial measures

The number of treatment-emergent adverse events reported by each subject during the trial.Up to 30 months
Complete responseUp to 6 months
defined as absence of any UTUC in the renal pelvis, i.e. negative urine cytology for high-grade urothelial carcinoma (centrally assessed), and either no suspicious lesions on ureteroscopy (investigator assessed) or a negative for-cause biopsy (centrally assessed).

Trialytics