Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma

Launched by UNIVERSITY OF BRITISH COLUMBIA · Nov 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ST-02, which is designed to help patients with low-grade upper tract urothelial carcinoma (a type of cancer affecting the kidneys and ureters). The researchers want to find out if ST-02 can safely eliminate the cancer within three months. Participants in the trial will receive the treatment once a week for six weeks, with the medicine being instilled directly into the kidney area through a small tube. They will be monitored for safety and effectiveness for up to a year after starting the treatment.

To join the trial, participants must be at least 18 years old and have a specific type of low-grade, non-invasive cancer that can be seen on tests. They should have measurable tumors and no active urinary infections. Women who could become pregnant and their partners must use reliable birth control during the trial. If you or a loved one meet these criteria and are interested, this trial could provide an opportunity to receive a new treatment while contributing to important cancer research.

Gender

ALL

Eligibility 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