NCT06124976RecruitingPhase 2/3
Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma
A Phase 2/3 Multicenter Trial Evaluating the Safety and Efficacy of ST-02 (Mucoadhesive Gemcitabine Suspension) on Ablation of Urothelial Carcinomas in the Upper Urinary Tract
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
The goal of this prospective clinical trial is to investigate the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to treat Upper Tract Urothelial Carcinoma (UTUC) in participants who have a low-grade tumor. The main questions this study aims to answer are: 1. Can ST-02 effectively eradicate UTUC by 3 months? 2. Is ST-02 safe for patients with UTUC? Participants in this study will receive ST-02, a new formulation with gemcitabine once weekly for six weeks. Gemcitabine is known to be an effective drug in treating urothelial carcinoma. This new formulation will be instilled directly into the upper urinary tract (renal pelvis) and will allow the chemotherapeutic to work locally for an extended period of time. The administration process will be retrograde (via a small catheter inserted up into the kidney, under anesthesia) or antegrade (via a nephrostomy, in the clinic) once weekly for six weeks. Safety and efficacy will be monitored for up to a year after the initial response assessment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 27 Oct 2023
- Start date
- 19 Jun 2024
- Primary completion date
- Apr 2028
- Lead sponsor
- Peter Black
- Diseases
- Bladder cancer
- NCT number
- NCT06124976
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 70
- From 19 Jun 2024 to the primary completion date, Apr 2028
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received Bacillus Calmette - Guerin (BCG) treatment for UTUC within 6 weeks prior to Visit 1 (D1)
- Unresolved infection requiring active treatment with systemic antimicrobial drugs
- Actively being treated or intend to be treated with intravesical or systemic chemotherapy during the duration of the trial
- Currently receiving another investigational agent or involved in a clinical trial with an investigational product within the past 30 days prior to Visit 1 (D1)
Other illness
- History of high-grade non-muscle invasive bladder cancer within the past 6 months
- History of muscle-invasive bladder cancer during the past 2 years
- Active hepatitis B (chronic or acute) or active hepatitis C infection
Other
- Pregnant (positive urine pregnancy test), planning pregnancy during trial, breast-feeding, or of childbearing potential without reliable contraception
- Urinary obstruction in the ipsilateral Upper Urinary Tract (UUT)
- Any contraindicated to gemcitabine or sensitivity to gemcitabine or any of the ST-02 ingredients
Who the study is looking for
- Adult (≥ 18 years) male or female
- Primary or recurrent low-grade (LG), noninvasive (Ta) Upper Tract Urothelial Carcinoma (UTUC) in the renal pelvis, infundibulum, and/or calyces, based on ureteroscopy, biopsy and cytology (disease assessment URS) performed within 8 weeks prior to or during the Screening Visit
- At least 1 measurable papillary tumor measuring 5-15 mm
- Low grade tumor(s) in the ipsilateral ureter. Every attempt should be made to ablate this tumor completely, but residual ipsilateral ureteral tumor is not an exclusion criterion.
- Prior fully ablated low grade bladder tumor(s), without the need for intravesical therapy except for single-dose chemotherapy
- A life expectancy of greater than 12 months
- No active untreated urinary tract infection (UTI) as confirmed by urine culture or urinalysis
- Women of Child bearing potential (WoCBP) and Males who have a WoCBP partner require a negative pregnancy test at the Screening visit and must use two acceptable contraceptives methods until six months post-treatment
- All sexually active males must agree to use a condom during intercourse, for at least 48 h after each instillation
- eGFR ≥10 mL/min; weekly creatinine monitoring recommended during treatment for participants with eGFR \<30 mL/min or a solitary functional kidney
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre of Applied Urology Research/Nova Scotia Health Authority Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| London Health Sciences Centre · Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| McGill University Health Center Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre de recherche du CHUS Coordinator of this site? Confirm its status | Sherbrooke | Canada | Not yet recruiting |
| UHN Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Vancouver Prostate Centre Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Men's Health Clinic Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.