Urothelial Carcinoma of the Renal Pelvis and Ureter study: ST-02
Official title Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma
ClinicalTrials.gov ID: NCT06124976
What this study is testing
What is ST-02?
ST-02 is an investigational medicine being studied as a potential treatment for low-grade urothelial carcinoma of the renal pelvis and ureter. ST-02 is designed to stick to the lining of the upper urinary tract to allow the chemotherapy drug gemcitabine to work locally for an extended period.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new gel called ST-02 can clear the cancer. It also checks if the gel is safe to use.
- Who it's for
- You may be able to join if you have a low-grade tumor in your kidney or ureter.
- What's involved
- You would get a gel with medicine put into your kidney. This happens once a week for six weeks.
- Time commitment
- The study lasts up to one year after your first check-up.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Prior fully ablated low grade bladder tumor(s), without the need for intravesical therapy except for single-dose chemotherapy
You likely can't join if
- 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
See the full eligibility criteria
- 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)...
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Vancouver, British Columbia, Canada
- Winnipeg, Manitoba, Canada
- Halifax, Nova Scotia, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.