Inactivated UPEC-FimON for Non Muscle Invasive Bladder Cancer After BCG or Intravesical Chemotherapy Failure

This is a Phase I, open-label, multicenter, dose-escalation study that aims to evaluate the safety and tolerability of intravesical inactivated Instillations of UPEC-FimON (Uro-Pathogenic E. coli) in participants with non-muscle invasive urothelial carcinoma (NMIUC) of the urinary bladder who failed previous Bacillus Calmette-Guérin (BCG) or intravesical chemotherapy. Up to 30 participants will be enrolled, with 3 participants per cohort, following a dose-escalation model, with the potential for dose expansion. Dose-escalation and dose modification decisions will be based on an assessment of

Trial Details

NCT ID
NCT07881666
Phase
PHASE1
Sponsor
Hopec Pharma
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Inactivated UPEC-FimON
Locations (sample)
  • Kfar Saba, Central District, Israel|32.175,34.90694
  • Jerusalem, Jerusalem, Israel|31.76904,35.21633
  • Ramat Gan, Tel Aviv, Israel|32.08227,34.81065

Key Eligibility Criteria

  • Male or female participants aged 18 years or older at the time of consent.
  • Participants who were diagnosed with non-muscle invasive urothelial carcinoma (NMIUC).
  • Participants who underwent complete transurethral excision of recurrent intermediate- to high-risk NMIUC; have no evidence of recurrent disease at …
  • Initial treatment scheduled within 8 weeks after the last transurethral resection of bladder tumor (TURBT).

For full eligibility, visit ClinicalTrials.gov.

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