Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma
NCT ID: NCT06124976
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2/PHASE3
70 participants
INTERVENTIONAL
2024-06-19
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
NCT04164082
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
NCT05710848
Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)
NCT04574960
S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
NCT00045630
S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
NCT00234039
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants with biopsy confirmed low-grade (LG) upper tract urothelial carcinoma (UTUC) and a tumor of 5 to 15 mm will receive 6 weekly instillations of ST-02.
The primary objective is to evaluate complete response (CR) at 3 months from the first instillation during the primary tumor evaluation (PTE) visit. This is done by ureteroscopy, and cytology, with or without biopsy if a tumor remains. If the participant presents as a CR, they will receive their first maintenance instillation of ST-02. Endoscopic monitoring of the upper tract with ureteroscopy for responders will be performed every 3 months for up to 12 months after CR, and the patient will receive a single instillation of ST-02 if no recurrence is noted each time.
Participants who do not have a CR will be treated by their physician with the standard of care, such as biopsy and laser ablation, and with any additional surgical procedure or treatment as deemed necessary by the Principal Investigator (PI).
The first stage of the trial will enroll 30 patients. If there are 8 or fewer CR among these 30 participants, the study will be stopped. Otherwise, an additional 40 participants will be accrued into phase 3, resulting in a total sample size of 70.
The durability of response, event-free survival, safety, and other outcomes will also be measured.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ST-02
ST-02 is a new gemcitabine formulation for instillation into the upper urinary tract. Eligible participants will be enrolled and receive ST-02 once weekly for six weeks in a retrograde or antegrade fashion at the discretion of the treating urologist.
ST-02
ST-02 drug instillation into the upper urinary tract (renal pelvis)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ST-02
ST-02 drug instillation into the upper urinary tract (renal pelvis)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 performed within 8 weeks prior to 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
Exclusion Criteria
* Pregnant (positive urine pregnancy test), planning pregnancy during trial, breast-feeding, or of childbearing potential without reliable contraception
* Unresolved infection requiring active treatment with systemic antimicrobial drugs
* 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
* Actively being treated or intend to be treated with intravesical or systemic chemotherapy during the duration of the trial
* Urinary obstruction in the ipsilateral Upper Urinary Tract (UUT)
* Any contraindicated to gemcitabine or sensitivity to gemcitabine or any of the ST-02 ingredients
* Currently receiving another investigational agent or involved in a clinical trial with an investigational product within the past 30 days prior to Visit 1
* Active hepatitis B (chronic or acute) or active hepatitis C infection
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Peter Black
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Black, Dr.
Role: PRINCIPAL_INVESTIGATOR
Vancouver Prostate Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vancouver Prostate Centre
Vancouver, British Columbia, Canada
Men's Health Clinic
Winnipeg, Manitoba, Canada
Centre of Applied Urology Research, Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
UHN - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Genevive Moreau
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H23-02476
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.