NCT07881666RecruitingPhase 1
Inactivated UPEC-FimON for Non Muscle Invasive Bladder Cancer After BCG or Intravesical Chemotherapy Failure
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
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Oct 2026
- Start date
- 25 Oct 2025
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Hopec Pharma
- Diseases
- Bladder cancer
- NCT number
- NCT07881666
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 25 Oct 2025 to the primary completion date, 1 Sept 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Recruiting |
| Sheba Medical Center, Tel Hashomer Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.