Phase 3 Kidney Cancer Trial, Recruiting NCT06124976 Sponsor: University of British Columbia Condition: Kidney Cancer
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Phase 3 Kidney Cancer Trial, Recruiting

NCT06124976
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older, of any gender
  • People who have a primary or returning low-grade, non-invasive type of urinary tract cancer (called Upper Tract Urothelial Carcinoma, or UTUC) located in the kidney's collecting system, confirmed by scope examination, biopsy, and urine testing done within 8 weeks before the screening visit
  • People who have at least one measurable tumour in the kidney's collecting system that is between 5 and 15 millimetres in size
  • People who have low-grade tumour(s) in the ureter on the same side (the tube connecting the kidney to the bladder) — complete removal of this tumour is attempted but is not required for participation
  • People who have previously had low-grade bladder tumours that were fully treated, where no ongoing bladder treatment was needed apart from a single-dose chemotherapy at most
  • People with a life expectancy of more than 12 months
  • People with no active, untreated urinary tract infection, confirmed by urine tests
  • Women who could become pregnant and men with partners who could become pregnant must have a negative pregnancy test at screening and use two acceptable forms of contraception until six months after treatment ends
  • All sexually active men must agree to use a condom during sexual intercourse for at least 48 hours after each treatment instillation

Who may not be able to join:

  • People who have received BCG treatment for UTUC within 6 weeks before the first visit
  • People who are pregnant, planning to become pregnant during the trial, breastfeeding, or of childbearing potential without reliable contraception in place
  • People who have an unresolved infection that is currently being treated with systemic antibiotic or antimicrobial medicines
  • People who have a history of high-grade non-muscle-invasive bladder cancer within the past 6 months
  • People who have a history of muscle-invasive bladder cancer within the past 2 years
  • People who are currently receiving, or plan to receive, chemotherapy delivered into the bladder or throughout the body during the trial period
  • People who have a blockage in the upper urinary tract on the same side as the tumour being treated
  • People who have a known allergy, sensitivity, or medical reason to avoid gemcitabine or any ingredient in the study treatment (ST-02)
  • People who are currently participating in another clinical trial involving an investigational treatment, or who have done so within the past 30 days before the first visit
  • People who have an active hepatitis B or hepatitis C infection

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Peter Black, Dr., Vancouver Prostate Centre

Phone: 236 869 3437

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
19 June 2024
Est. completion
1 April 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Complete Response (CR) rate at the Primary Tumor Evaluation (PTE) visit

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov