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Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

A Phase 1/2, Single-arm, Open-Label Trial to Evaluate the Safety and Efficacy of Nadofaragene Firadenovec Instilled to the Renal Pelvis in Adult Subjects With Low-grade Upper Tract Urothelial Carcinoma (LG-UTUC)

NCT06668493•Ferring Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥18 years at the time of signing informed consent.
•2. Able to give written informed consent.
•3. Have biopsy-proven low-grade upper tract urothelial cancer (LG-UTUC) confirmed by a pathology report ≤2 months prior to enrolment.
•4. Have ≥1 measurable papillary low-grade tumour (5-15 mm in maximum diameter), evaluated visually above the ureteropelvic junction 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:
+36 more criteria

Exclusion Criteria

•1. UTUC characterised by one or more of the following:
•* High-grade cytology or high-grade histology
•* Multi-focal UTUC

Locations (7)

Mayo Clinic - Scottsdale Arizona

Scottsdale, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

Indiana University

Indianapolis, Indiana, United States

Mayo Clinic - Rochester Minnesota

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center - Genitourinary (GU) Cancer Center

Houston, Texas, United States

Key Dates

Start Date

June 12, 2025

Primary Completion Date

November 30, 2029

Completion Date

November 30, 2029

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Low-grade Upper Tract Urothelial Carcinoma

Interventions

Nadofaragene Firadenovec

DRUG

Contacts

Ferring Pharmaceuticals

CONTACT

1-888-337-7464 Disclosure@ferring.com