Using ST-02 to treat low-grade 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
This study is testing a new treatment called ST-02 to see if it can safely help people with low-grade upper tract urothelial carcinoma feel better after receiving weekly treatments for six weeks.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Vancouver, British Columbia and 3 other locations) |
| Trial ID | NCT06124976 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of ST-02, a mucoadhesive gemcitabine suspension, for the treatment of low-grade upper tract urothelial carcinoma (UTUC). Participants with biopsy-confirmed low-grade tumors measuring 5 to 15 mm will receive weekly instillations of ST-02 for six weeks. The primary objective is to evaluate the complete response rate at three months post-treatment, monitored through ureteroscopy and cytology. If successful, patients will continue to receive maintenance treatments every three months for up to a year.
Who should consider this trial
Good fit: Ideal candidates are adults with biopsy-confirmed low-grade, noninvasive UTUC tumors measuring 5 to 15 mm.
Not a fit: Patients with high-grade tumors or active urinary tract infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a localized and effective option for patients with low-grade UTUC, potentially reducing the need for more invasive procedures.
How similar studies have performed: While similar approaches have been explored, this specific formulation and method of administration is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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: * Have received Bacillus Calmette - Guerin (BCG) treatment for UTUC within 6 weeks prior to Visit 1 * 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
Where this trial is running
Vancouver, British Columbia and 3 other locations
- Vancouver Prostate Centre — Vancouver, British Columbia, Canada (Recruiting)
- Men's Health Clinic — Winnipeg, Manitoba, Canada (Recruiting)
- Centre of Applied Urology Research, Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
- UHN - Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Peter Black, Dr. — Vancouver Prostate Centre
- Study coordinator: Dasa Durkotova
- Email: ddurkotova@prostatecentre.com
- Phone: 236 869 3437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.