Testing ST-02 for urothelial carcinoma of the renal pelvis and ureter
Official title: 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
- Phase 2
- 1 group
- Sites in Vancouver, Winnipeg and 5 more cities
- Recruiting
Interventions
- Medication
ST-02
ST-02 drug instillation into the upper urinary tract (renal pelvis)
Canadian Sites (8)
6 of 8 recruiting
- Recruiting
Vancouver Prostate Centre
Vancouver, British Columbia
- Recruiting
Men's Health Clinic
Winnipeg, Manitoba
- Recruiting
Centre of Applied Urology Research, Nova Scotia Health Authority
Halifax, Nova Scotia
- Recruiting
London Health Sciences Centre - Victoria Hospital
London, Ontario
- Recruiting
UHN - Princess Margaret Cancer Centre
Toronto, Ontario
- Recruiting
McGill University Health Center
Montreal, Quebec
- Not yet recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
- Not yet recruiting
Centre de recherche du CHUS
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for20 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +At least 1 measurable papillary tumor measuring 5-15 mm
- +Women of Child bearing potential (WoCBP) and Males who have a WoCBP partner require a negative pregnancy test at the Screening visitScreeningThe checks done before joining, to see whether a study fits.Read more → and must use two acceptable contraceptives methods until six months post-treatment
- +eGFR ≥10 mL/min; weekly creatinine monitoring recommended during treatment for participants with eGFR \<30 mL/min or a solitary functional kidney
- +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
- +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 criterionExclusion criteriaThe things that would prevent someone from taking part.Read more →.
- +A life expectancy of greater than 12 months
- +No active untreated urinary tract infection (UTI) as confirmed by urine culture or urinalysis
- +All sexually active males must agree to use a condom during intercourse, for at least 48 h after each instillation
- +Prior fully ablated low grade bladder tumor(s), without the need for intravesical therapy except for single-dose chemotherapy
Exclusion
- −Active hepatitis B (chronic or acute) or active hepatitis C infection
- −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
- −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
- −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 trialInterventional studyA study where participants are given something to see what happens.Read more → with an investigational product within the past 30 days prior to Visit 1 (D1)
- −Pregnant (positive urine pregnancy test), planning pregnancy during trial, breast-feeding, or of childbearing potential without reliable contraception
- −Actively being treated or intend to be treated with intravesical or systemic chemotherapy during the duration of the trial
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives ST-02.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 70 people.
The study is currently expected to finish around June 2028.
The main measurement is taken over: 3 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Complete Response (CR) rate at the Primary Tumor Evaluation (PTE) visit — measured over 3 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06124976 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ST-02Drug
ST-02 drug instillation into the upper urinary tract (renal pelvis)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 3 months.
The study as a whole is currently expected to finish around 2028-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 70 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.