Urinary Bladder NeoplasmsPhase 1NCT07881666
Inactivated UPEC-FimON for Non Muscle Invasive Bladder Cancer After BCG or Intravesical Chemotherapy Failure
A Phase 1 study testing Inactivated UPEC-FimON in people with Urinary Bladder Neoplasms, run by Hopec Pharma at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Inactivated UPEC-FimON
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesIsrael
- Study dates
- 25 Oct 2025to 1 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel3 sites, 3 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem, Jerusalem
Vladimir Yutkin, MD, yutkin@hadassah.org.il
Vladimir Yutkin, MD
- Recruiting
Meir Medical Center
Kfar Saba, Central District
Omri Schwarztuch Gildor, MD, omri.gildor@clalit.org.il
Omri Schwarztuch Gildor, MD
- Recruiting
Sheba Medical Center, Tel HaShomer
Ramat Gan, Tel Aviv
Zohar Dotan, MD, PhD, zohar.dotan@sheba.health.gov.il
Zohar Dotan, MD, PhD
About this study
Official title: 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).
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Inactivated UPEC-FimON
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated UPEC-FimONBiological
Inactivated UPEC-FimON (Uro-Pathogenic E. coli) administered intravesically once weekly for 6 weeks. The dose will be escalated across sequential cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Inactivated UPEC-FimON Receives: Biological: Inactivated UPEC-FimON |
| Cohort 2 | Experimental | Inactivated UPEC-FimON Receives: Biological: Inactivated UPEC-FimON |
| Cohort 3 | Experimental | Inactivated UPEC-FimON Receives: Biological: Inactivated UPEC-FimON |
| Cohort 4 | Experimental | Inactivated UPEC-FimON Receives: Biological: Inactivated UPEC-FimON |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From first study treatment through Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start25 Oct 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants will be enrolled sequentially into dose-escalation cohorts of intravesical Instillations of inactivated UPEC-FimON. Each cohort will include 3 participants. Dose escalation, dose modifications and potential cohort expansion decisions will be based on assessment of dose-limiting toxicities (DLTs), overall safety, and tolerability, and will be agreed upon by the Data Safety Monitoring Board (DSMB).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopec Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881666
- Sponsor's protocol ID
- HOPEC-01
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07881666
- Acronym / sponsor ID
- HOPEC-01
- Conditions
- Urinary Bladder Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hopec PharmaIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be enrolled sequentially into dose-escalation cohorts of intravesical Instillations of inactivated UPEC-FimON. Each cohort will include 3 participants. Dose escalation, dose modifications and potential cohort expansion decisions will be based on assessment of dose-limiting toxicities (DLTs), overall safety, and tolerability, and will be agreed upon by the Data Safety Monitoring Board (DSMB).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Inactivated UPEC-FimONInactivated UPEC-FimON |
| Cohort 2 | Experimental | Biological: Inactivated UPEC-FimONInactivated UPEC-FimON |
| Cohort 3 | Experimental | Biological: Inactivated UPEC-FimONInactivated UPEC-FimON |
| Cohort 4 | Experimental | Biological: Inactivated UPEC-FimONInactivated UPEC-FimON |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactivated UPEC-FimONInactivated UPEC-FimON (Uro-Pathogenic E. coli) administered intravesically once weekly for 6 weeks. The dose will be escalated across sequential cohorts. | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Safety and Tolerability of Inactivated UPEC-FimON administered intravesically
Time frame: From first study treatment through Week 14
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Urinary Bladder Neoplasms
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inactivated UPEC-FimON in people with Urinary Bladder Neoplasms, run by Hopec Pharma at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gadi Klarsfeld (+972-54-727-8898, gadi@hopec-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Inactivated UPEC-FimON administered intravesically (time frame: From first study treatment through Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.