Inactivated E. coli placed in the bladder for bladder cancer after earlier treatment failed
Tests inactivated UPEC-FimON in adults with bladder cancer after BCG or chemotherapy failed.
Plain-language title generated from the registry record
Registry title: Inactivated UPEC-FimON for Non Muscle Invasive Bladder Cancer After BCG or Intravesical Chemotherapy Failure
Key facts
- Where
- Jerusalem, Kfar Saba, and Ramat Gan, IsraelSee the 3 sites
- Phase
- Phase 1
Where in Israel
- Hadassah medical CenterJerusalem, IsraelTaking people
- Meir Medical CenterKfar Saba, IsraelTaking people
- Sheba Medical Center, Tel HashomerRamat Gan, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hopec Pharma
- Trial code
- NCT07881666
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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
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).
Inclusion: 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 screening cystoscopy and urine cytology (residual carcinoma in situ [CIS] is acceptable); and have a 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; Initial treatment scheduled within 8 weeks after the last transurethral resection of bladder tumor (TURBT); Women of childbearing potential must use a highly effective contraceptive method and have a negative serum beta-human chorionic gonadotropin (β-hCG) test at screening and a negative urine pregnancy test before the first study-drug administration; Male participants agree to use a condom for 1 week post each treatment.
Exclusion: Concomitant upper tract urothelial carcinoma; Any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 1 at the time of starting study treatment; Active urinary tract infection; Other active malignancies, except for basal cell carcinoma (BCC); Active, uncontrolled systemic bacterial, viral, fungal, or parasitic infection; Any other medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or compromise the participant's ability to participate in the study; Use of immunomodulating and/or immunosuppressive drugs in the past 6 months, and prophylactic use of nutritional supplements for the prevention of urinary tract infection from screening through the Week 14 visit; Pregnant or breast-feeding women, or women who plan to breastfeed during the study; Muscle-invasive urothelial carcinoma; Metastatic urothelial carcinoma; Karnofsky Performance Status below 60; Known immunodeficiency or immunodeficient status.