Urothelial Carcinoma of the Renal Pelvis and UreterPhase 2/3NCT06124976
Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma
A Phase 2/3 study testing ST-02 in people with Urothelial Carcinoma of the Renal Pelvis and Ureter and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Peter Black at 8 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma of the Renal Pelvis and Ureter, Transitional Cell Cancer of the Renal Pelvis and Ureter
- What is being tested?
- ST-02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 8 sitesCanada
- Study dates
- 19 Jun 2024to Jun 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Have received Bacillus Calmette - Guerin (BCG) treatment for UTUC within 6 weeks prior to Visit 1 (D1)
- 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
Show all 10Show fewer
- 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 (D1)
- Active hepatitis B (chronic or acute) or active hepatitis C infection
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Canada8 sites, 8 recruiting
- Recruiting
Centre of Applied Urology Research, Nova Scotia Health Authority
Halifax, Nova Scotia
Jessica Blandin, 902 473 3470, jessica.blandin@nshealth.ca
Ricardo Rendon, Dr.
- Recruiting
London Health Sciences Centre - Victoria Hospital
London, Ontario
Kaydee Connors, 519 685 8500 ext. 56366, Kaydee.Connors@lhsc.on.ca
Melissa Huynh, Dr.
- Not yet recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
Amal Nadiri, 514 890 8000 ext. 26074, amal.nadiri.chum@ssss.gouv.qc.ca
Mounsif Azizi, Dr.
- Recruiting
McGill University Health Center
Montreal, Quebec
Laetitia Burzoo, 514 934 1934 ext. 36674, laetitia.burzoo@muhc.mcgill.ca
Alexandra Buccilli, 514 934 1934 ext. 34905, alexandra.buccilli@muhc.mcgill.ca
- Not yet recruiting
Centre de recherche du CHUS
Sherbrooke, Quebec
Andrée-Anne Turcotte, 819 346 1110 ext. 13446, andree-anne.turcotte.ciussse-chus@ssss.gouv.qc.ca
Claudio Jeldres, Dr.
- Recruiting
UHN - Princess Margaret Cancer Centre
Toronto, Ontario
Amanda Liu, 416 946 4501 ext. 3897, Amanda.liu@uhn.ca
Girish Kulkarni, Dr.
- Recruiting
Vancouver Prostate Centre
Vancouver, British Columbia
Genevive Moreau, 604 875 4111 ext. 67898, gbaloloy@prostatecentre.com
Marie-Pier St-Laurent, Dr.
- Recruiting
Men's Health Clinic
Winnipeg, Manitoba
Gayle Nickol, 204 221 4476, research@mhclinic.ca
Jasmir Nayak, Dr.
About this study
Official title: 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
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:
Read more
- Can ST-02 effectively eradicate UTUC by 3 months?
- 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.
Read the detailed description
This study is a prospective, multicenter, single-arm, open-label clinical trial assessing the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to chemo-ablate low-grade urothelial carcinoma of the upper urinary tract.
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), defined as absence of tumor above the ureteropelvic junction 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
- Urothelial Carcinoma of the Renal Pelvis and Ureter, Transitional Cell Cancer of the Renal Pelvis and Ureter
- Being tested
- ST-02
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST-02Drug
ST-02 drug instillation into the upper urinary tract (renal pelvis)
| Study group | Role | What they receive |
|---|---|---|
| ST-02 | Experimental | 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. Receives: Drug: ST-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) rate at the Primary Tumor Evaluation (PTE) visit
To evaluate the tumor ablative effect (CR after 3 months) of six instillations of ST-02 in the upper urinary tract of participants with UTUC.
Measured: 3 months
Secondary outcomes (8)
Durable efficacy
To evaluate the durability of tumor ablative effect 12 months after CR in participants who demonstrated complete response at 3 months after instillation of six doses of ST-02
Measured: 12 months after CR
Objective Response Rate (ORR)
To evaluate the objective response rate after treatment with ST-02, defined as proportion of participants with Complete Response (CR) or Partial Response (PR) at the PTE Visit
Measured: 3 months
Event-Free Survival (EFS)
To evaluate the event-free survival after treatment with ST-02
Measured: 15 months
Number of adverse event
To evaluate the safety and tolerability of instillation of ST-02 in participants with UTUC
Measured: 15 months
Peak Plasma Concentration (Cmax)
To assess the peak concentration of gemcitabine in urine and plasma at 0, 1, 2, 4 and 24 hours after instillation (10 patients, phase 2 only)
Measured: 24 hours
Pharmacokinetics (Tmax)
To assess the time to maximal concentration of gemcitabine in urine and plasma at 0, 1, 2, 4 and 24 hours after instillation (10 patients, phase 2 only)
Measured: 24 hours
Rate of invasive surgery
To evaluate the rate of nephroureterectomy following instillation of ST-02
Measured: 15 months
Clinical impact of PR in not endoscopically resectable UTUC
To evaluate the proportion of participants with PR whose tumors were considered not endoscopically resectable at baseline but are endoscopically resectable after treatment with ST-02
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start19 Jun 2024
- Primary completionApr 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma of the Renal Pelvis and UreterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Black
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Black, University of British Columbia
- Investigators
- Marie-Pier St-Laurent, Dr., Principal investigator, Vancouver Prostate Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124976
- Sponsor's protocol ID
- H23-02476
- Status last verified
- Jun 2026
- First submitted
- 27 Oct 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06124976
- Acronym / sponsor ID
- H23-02476
- Conditions
- Urothelial Carcinoma of the Renal Pelvis and Ureter, Transitional Cell Cancer of the Renal Pelvis and Ureter
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peter BlackUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can ST-02 effectively eradicate UTUC by 3 months?
- 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.
Detailed description
This study is a prospective, multicenter, single-arm, open-label clinical trial assessing the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to chemo-ablate low-grade urothelial carcinoma of the upper urinary tract.
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), defined as absence of tumor above the ureteropelvic junction 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ST-02 | Experimental | Drug: ST-02ST-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- Have received Bacillus Calmette - Guerin (BCG) treatment for UTUC within 6 weeks prior to Visit 1 (D1)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST-02ST-02 drug instillation into the upper urinary tract (renal pelvis) | Drug | ST-02 |
Primary outcome
Complete Response (CR) rate at the Primary Tumor Evaluation (PTE) visit
Time frame: 3 months
To evaluate the tumor ablative effect (CR after 3 months) of six instillations of ST-02 in the upper urinary tract of participants with UTUC.
8 secondary outcomes
Durable efficacy
Time frame: 12 months after CR
Objective Response Rate (ORR)
Time frame: 3 months
Event-Free Survival (EFS)
Time frame: 15 months
Number of adverse event
Time frame: 15 months
Peak Plasma Concentration (Cmax)
Time frame: 24 hours
Pharmacokinetics (Tmax)
Time frame: 24 hours
Rate of invasive surgery
Time frame: 15 months
Clinical impact of PR in not endoscopically resectable UTUC
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Pier St-Laurent, Dr. principal investigator
Vancouver Prostate Centre
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ST-02 in people with Urothelial Carcinoma of the Renal Pelvis and Ureter and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Peter Black at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dasa Durkotova (236 869 3437, ddurkotova@prostatecentre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) rate at the Primary Tumor Evaluation (PTE) visit (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.