NCT06124976

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. 1.Can ST-02 effectively eradicate UTUC by 3 months?
  2. 2.Is ST-02 safe for patients with UTUC?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

June 19, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 15, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

October 27, 2023

Last Update Submit

September 8, 2025

Conditions

Urothelial Carcinoma of the Renal Pelvis and UreterTransitional Cell Cancer of the Renal Pelvis and Ureter

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (8)

  • Durable efficacy

    12 months after CR

  • Objective Response Rate (ORR)

    3 months

  • Event-Free Survival (EFS)

    15 months

  • Number of adverse event

    15 months

  • Peak Plasma Concentration (Cmax)

    24 hours

  • +3 more secondary outcomes

Study Arms (1)

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.

Drug: ST-02

Interventions

ST-02DRUG

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

ST-02

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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, 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vancouver Prostate Centre

Vancouver, British Columbia, Canada

RECRUITING

Men's Health Clinic

Winnipeg, Manitoba, R3P 2S8, 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 Officials

  • Peter Black, Dr.

    Vancouver Prostate Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dasa Durkotova

CONTACT

236 869 3437ddurkotova@prostatecentre.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 9, 2023

Study Start

June 19, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

September 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)