Inactivated UPEC-FimON for Bladder Cancer After BCG or Intravesical Therapy Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase I, open-label, multicenter, dose-escalation trial evaluating the safety and tolerability of intravesical inactivated UPEC-FimON for patients with non-muscle invasive urothelial carcinoma who have failed prior BCG or intravesical chemotherapy. Up to 30 participants will be enrolled in cohorts of three, with potential dose expansion. Dose decisions will be guided by dose-limiting toxicities, overall safety, and input from a Data Safety Monitoring Board. The study aims to establish a safe dosage range and identify initial signals of tolerability in this population. Eligible adults must have undergone complete TURBT with no recurrent disease at screening, except possible residual CIS, and a history of at least one prior intravesical immunotherapy or chemotherapy failure within two years.

Why it matters

Who can join: the full rules

Inclusion 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 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 Criteria:

* Pregnant or breast-feeding women, or women who plan to breastfeed during the study.
* Concomitant upper tract urothelial carcinoma.
* Muscle-invasive urothelial carcinoma.
* Metastatic urothelial carcinoma.
* Karnofsky Performance Status below 60.
* Known immunodeficiency or immunodeficient status.
* Active urinary tract infection.
* Other active malignancies, except for basal cell carcinoma (BCC).
* Any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 1 at the time of starting study treatment.
* 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.

Where it's running

• Meir Medical Center
  Kfar Saba, Central District, Israel Recruiting
• Hadassah Medical Center
  Jerusalem, Jerusalem, Israel Recruiting
• Sheba Medical Center, Tel HaShomer
  Ramat Gan, Tel Aviv, Israel Recruiting

Study contacts

• Study coordinator: Gadi Klarsfeld
• Email: gadi@hopec-pharma.com
• Phone: +972-54-727-8898

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.