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.
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.
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
Single group
ST-02
DrugST-02 drug instillation into the upper urinary tract (renal pelvis)
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.
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
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
Event-Free Survival (EFS)
To evaluate the event-free survival after treatment with ST-02
Number of adverse event
To evaluate the safety and tolerability of instillation of ST-02 in participants with UTUC
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Peter Black
Lead sponsor
University of British Columbia
Sponsor institution
