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RecruitingNCT07881666Updated Oct 19, 2026

Phase I Study of Inactivated UPEC-FimON for Non Muscle Invasive Bladder Cancer After BCG or Intravesical Chemotherapy Failure

A Phase 1 interventional study of Inactivated UPEC-FimON in Urinary Bladder Neoplasms, sponsored by Hopec Pharma. Recruiting at 3 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Hopec Pharma · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2025, registered Oct 2026).
  • Started Oct 2025; still recruiting 1 year later.
Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Urinary Bladder Neoplasms
03

In context

Urinary Bladder Neoplasms

1,649 studies on the registry are indexed under Urinary Bladder Neoplasms; 427 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 1,183 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

This is the only study on the registry with Hopec Pharma as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    3 participants will receive 1 vial of inactivated UPEC-FimON intravesically once weekly for 6 weeks.

    Biological: Inactivated UPEC-FimON

  • Experimental
    Cohort 2

    3 participants will receive 3 vials of inactivated UPEC-FimON intravesically once weekly for 6 weeks.

    Biological: Inactivated UPEC-FimON

  • Experimental
    Cohort 3

    3 participants will receive 6 vials of inactivated UPEC-FimON intravesically once weekly for 6 weeks.

    Biological: Inactivated UPEC-FimON

  • Experimental
    Cohort 4

    3 participants will receive 10 vials of inactivated UPEC-FimON intravesically once weekly for 6 weeks.

    Biological: Inactivated UPEC-FimON

Interventions

  • BiologicalInactivated UPEC-FimON

    Inactivated UPEC-FimON (Uro-Pathogenic E. coli) administered intravesically once weekly for 6 weeks. The dose will be escalated across sequential cohorts.

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability of Inactivated UPEC-FimON administered intravesically

    Safety and tolerability will be assessed by the incidence, severity, seriousness, and relationship to study treatment of adverse events and serious adverse events, including dose-limiting toxicities (DLTs).

    Time frame: From first study treatment through Week 14

07

Study locations

3 of 3 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Sep 2027, 22 months after the start.

Of 65 industry-sponsored phase 1 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 72. This study's planned 22 months is below that.

Counting every sponsor, half of 121 studies reached it within 45 months; a quarter within 29 and three quarters within 74.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2026
First posted
Oct 19, 2026
StartActual
Oct 25, 2025
Primary completionEst.
Sep 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07881666
Lead sponsor
Hopec Pharma
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Oct 25, 2025
Primary completion
Sep 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Oct 19, 2026

Study contacts

Gadi Klarsfeld
Contact
gadi@hopec-pharma.com
+972-54-727-8898

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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