Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis (NCT06668493) | Clinical Trial Compass
RecruitingPhase 1/2
Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis
United States20 participantsStarted 2025-06-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged ≥18 years at the time of signing informed consent.
✓. Able to give written informed consent.
✓. Have biopsy-proven low-grade upper tract urothelial cancer (LG-UTUC) confirmed by a pathology report ≤2 months prior to enrolment.
✓. Have ≥1 measurable papillary low-grade tumour (5-15 mm in maximum diameter), evaluated visually above the ureteropelvic junction before enrolment.
✓. Willing to be available for at least 18 months after first dosing.
✓. Have life expectancy \>2 years, in the opinion of the investigator.
✓. Have an Eastern Cooperative Oncology Group (ECOG) status of 2 or less.
✓. 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.
Exclusion criteria
✕. UTUC characterised by one or more of the following:
What they're measuring
1
The number of treatment-emergent adverse events reported by each subject during the trial.
✕. Current or previous evidence of carcinoma in situ, of muscle invasive (muscularis propria) urothelial cancer in the urogenital tract presented at the screening visit.
✕. Concomitant lower tract urothelial carcinoma and/or concomitant or prior urothelial carcinoma within the prostatic urethra.
✕. History of high grade papillary urothelial cancer within 2 years prior to screening.
✕. Current or prior treatment with mitomycin gel and/or any investigational drug for the treatment of UTUC.
✕. Current systemic chemo- or immunotherapy for bladder cancer or any other malignancy.
✕. 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.
✕. Current or prior retroperitoneal external beam radiotherapy within 5 years of screening.