Recruiting
Phase 2
Phase 3

ST-02

Sponsor:

Peter Black

Code:

NCT06124976

Conditions

Urothelial Carcinoma of the Renal Pelvis and Ureter

Transitional Cell Cancer of the Renal Pelvis and Ureter

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ST-02

Study Details

Brief 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. 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.

Conditions

Urothelial Carcinoma of the Renal Pelvis and Ureter

Transitional Cell Cancer of the Renal Pelvis and Ureter

Study ID

NCT06124976

Start date

Jun 19, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 (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
  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

ST-02

ST-02 drug instillation into the upper urinary tract (renal pelvis)

Primary outcome measure

  • Complete Response (CR) rate at the Primary Tumor Evaluation (PTE) visit [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Dasa Durkotova

236 869 3437ddurkotova@prostatecentre.com

Locations

Vancouver Prostate Centre

Recruiting

Vancouver, British Columbia, Canada

Contacts

Genevive Moreau

604 875 4111gbaloloy@prostatecentre.com

Principal Investigator:

Marie-Pier St-Laurent, Dr.

Men's Health Clinic

Recruiting

Winnipeg, Manitoba, Canada

Contacts

Gayle Nickol

204 221 4476research@mhclinic.ca

Principal Investigator:

Jasmir Nayak, Dr.

Centre of Applied Urology Research, Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada

Contacts

Jessica Blandin

902 473 3470jessica.blandin@nshealth.ca

Principal Investigator:

Ricardo Rendon, Dr.

London Health Sciences Centre - Victoria Hospital

Recruiting

London, Ontario, Canada

Contacts

Kaydee Connors

519 685 8500Kaydee.Connors@lhsc.on.ca

Principal Investigator:

Melissa Huynh, Dr.

UHN - Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada

Contacts

Amanda Liu

416 946 4501Amanda.liu@uhn.ca

Principal Investigator:

Girish Kulkarni, Dr.

McGill University Health Center

Recruiting

Montreal, Quebec, Canada

Contacts

Laetitia Burzoo

514 934 1934laetitia.burzoo@muhc.mcgill.ca

Alexandra Buccilli

514 934 1934alexandra.buccilli@muhc.mcgill.ca

Principal Investigator:

Alexis Rompré-Brodeur, Dr.

More Information

Sponsor

Peter Black

Last update posted

Aug 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Peter Black on 2026-08-03.