💬In plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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