OncoMatch/Clinical Trials/NCT07881666
Phase I Study of Inactivated UPEC-FimON for Non Muscle Invasive Bladder Cancer After BCG or Intravesical Chemotherapy Failure
Official title: Phase I, Open-label, Multicenter Trial, to Evaluate the Safety and Tolerability of Intravesical Inactivated 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
Is NCT07881666 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies Inactivated UPEC-FimON for urinary bladder neoplasms.
Treatment: Inactivated UPEC-FimON — 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 dose-limiting toxicities (DLTs), overall safety, and tolerability, and will be agreed upon by the Data Safety Monitoring Board (DSMB).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Urothelial Carcinoma
Prior therapy
Must have received: adjuvant intravesical immunotherapy or chemotherapy (BCG) — within 2 years before recurrence
history of at least one course of adjuvant intravesical immunotherapy or chemotherapy within 2 years before recurrence, i.e., BCG- or intravesical chemotherapy-failure NMIUC
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07881666 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received adjuvant intravesical immunotherapy or chemotherapy.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages