Non-Muscle Invasive Bladder CancerPhase 3NCT04859751
Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer
A Phase 3 study testing VB4-845 Injection in people with Non-Muscle Invasive Bladder Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. VB4-845 injection is an experimental agent that may provide an alternative to cystectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Cancer
- What is being tested?
- VB4-845 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2021to Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Histologically-confirmed non muscle-invasive urothelial carcinoma (transitional cell carcinoma) of the bladder.
- Subjects must have received adequate BCG treatment defined as at least 2 courses of BCG, i.e., at least one induction and one maintenance course or at least 2 induction courses.
- The subject's disease is refractory or has relapsed following adequate BCG treatment.
- Male or non-pregnant, non-breastfeeding female, age 18 years or older at date of consent.
- All women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of the first dose of study therapy.
- All sexually active subjects agree to use barrier contraception (i.e., condoms) while receiving study treatment and for 120 days following their last dose of study treatment.
- Karnofsky performance status ≥ 60.
- Ability to understand and sign an Independent Ethics Committee-or Institutional Review Board-approved informed consent document.
Who cannot join
- The subject is pregnant or breastfeeding.
- Evidence of urethral or upper tract transitional cell carcinoma (TCC) within the past 2 years.
- Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding and diagnostic evaluation at Screening shows no evidence of tumor.
- Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug.
- History of recurrent severe urinary tract infections (UTIs) per investigator judgment. Subjects with a current UTI requiring antibiotic treatment may defer the initiation of Vicinium treatment on Day 1 until resolution of the UTI.
- he subject has a diagnosis of another malignancy within 2 years before the first dose of study treatment.
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- A QTc interval of >470 msec by the Fridericia formula (QTcF), at the Screening ECG.
- Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s).
- Local or severe allergy to any components of the drug regimen.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Dingwei Ye, PI
About this study
Official title: An Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy and Safety of Intravesical VB4-845 Injection in Patients With Non-Muscle Invasive Bladder Cancer
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. VB4-845 injection is an experimental agent that may provide an alternative to cystectomy
Read the detailed description
Bladder cancer is the 6th most common cancer in the United States, affecting more men than women. The usual first treatment for NMIBC (Ta, T1,and CIS) is transurethral resection of the bladder tumors followed by intravesical immunotherapy, most commonly with bacillus Calmette-Guérin (BCG).
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS and high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. For patients unable or unwilling to undergo cystectomy, treatment options are limited.
VB4-845 injection is a recombinant fusion protein produced in Escherichia coli (E. coli) that expresses a humanized single-chain antibody fragment specific for the epithelial cell adhesion molecule (EpCAM) antigen linked to exotoxin A (ETA[252-608]). Once bound to the EpCAM antigen on the surface of carcinoma cells, Vicinium is internalized through an endocytic pathway. The ETA(252-608) is cleaved off and induces cell death by irreversibly blocking protein synthesis.
This is an open-label, non-randomized, multicenter bridging study in Chinese patients with NMIBC, specifically CIS (with or without papillary disease), high-grade Ta or any grade T1 papillary disease, who have previously failed BCG treatment (i.e., not those who are intolerant) with or without interferon. The study consists of a Screening period, a 12-week Induction Phase, and a Maintenance Phase of up to 21 monthly cycles for a total treatment period of up to104 weeks.
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Being tested
- VB4-845 Injection
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB4-845 InjectionDrug
Intravesical administration of VB4-845 Injection.
| Study group | Role | What they receive |
|---|---|---|
| VB4-845 Injection | Experimental | Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks. Receives: Drug: VB4-845 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Complete response rate in patients with CIS with or without resected papillary disease following initiation of VB4-845 injection therapy
Measured: up to 6 months
Secondary outcomes (4)
Recurrence-free rate
Recurrence-free (RF) rate in patients with high-grade Ta or any grade T1 papillary disease (without CIS)
Measured: up to 6 months
Complete response rate
Complete response rate in patients with CIS with or without resected papillary disease following initiation of VB4-845 injection therapy
Measured: up to 3 months
Recurrence-free rate
Recurrence-free (RF) rate in patients with high-grade Ta or any grade T1 papillary disease (without CIS)
Measured: up to 3 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Frequency and severity of adverse events. Including adverse events (AEs), change in physical examination findings, change in vital signs, clinical laboratory testing for systemic safety,including liver function, renal function, compelete blood count, and clinical chemistries.
Measured: Every 4 weeks up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start23 Mar 2021
- Primary completionJun 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dingwei Ye, PI, Principal investigator, Shanghai Fudan University Affiliated Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859751
- Sponsor's protocol ID
- VB4-845-CN-001
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- 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 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy and Safety of Intravesical VB4-845 Injection in Patients With Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT04859751
- Acronym / sponsor ID
- VB4-845-CN-001
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Apr 2021 (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.
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. VB4-845 injection is an experimental agent that may provide an alternative to cystectomy
Detailed description
Bladder cancer is the 6th most common cancer in the United States, affecting more men than women. The usual first treatment for NMIBC (Ta, T1,and CIS) is transurethral resection of the bladder tumors followed by intravesical immunotherapy, most commonly with bacillus Calmette-Guérin (BCG).
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS and high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. For patients unable or unwilling to undergo cystectomy, treatment options are limited.
VB4-845 injection is a recombinant fusion protein produced in Escherichia coli (E. coli) that expresses a humanized single-chain antibody fragment specific for the epithelial cell adhesion molecule (EpCAM) antigen linked to exotoxin A (ETA[252-608]). Once bound to the EpCAM antigen on the surface of carcinoma cells, Vicinium is internalized through an endocytic pathway. The ETA(252-608) is cleaved off and induces cell death by irreversibly blocking protein synthesis.
This is an open-label, non-randomized, multicenter bridging study in Chinese patients with NMIBC, specifically CIS (with or without papillary disease), high-grade Ta or any grade T1 papillary disease, who have previously failed BCG treatment (i.e., not those who are intolerant) with or without interferon. The study consists of a Screening period, a 12-week Induction Phase, and a Maintenance Phase of up to 21 monthly cycles for a total treatment period of up to104 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VB4-845 Injection | Experimental | Drug: VB4-845 InjectionInduction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks. Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically-confirmed non muscle-invasive urothelial carcinoma (transitional cell carcinoma) of the bladder.
- Subjects must have received adequate BCG treatment defined as at least 2 courses of BCG, i.e., at least one induction and one maintenance course or at least 2 induction courses.
- The subject's disease is refractory or has relapsed following adequate BCG treatment.
- Male or non-pregnant, non-breastfeeding female, age 18 years or older at date of consent.
- All women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of the first dose of study therapy.
Key exclusion criteria (9 listed)
- The subject is pregnant or breastfeeding.
- Evidence of urethral or upper tract transitional cell carcinoma (TCC) within the past 2 years.
- Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding and diagnostic evaluation at Screening shows no evidence of tumor.
- Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug.
- History of recurrent severe urinary tract infections (UTIs) per investigator judgment. Subjects with a current UTI requiring antibiotic treatment may defer the initiation of Vicinium treatment on Day 1 until resolution of the UTI.
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 |
|---|---|---|
| VB4-845 InjectionIntravesical administration of VB4-845 Injection. | Drug | VB4-845 Injection |
Primary outcome
Complete response rate
Time frame: up to 6 months
Complete response rate in patients with CIS with or without resected papillary disease following initiation of VB4-845 injection therapy
4 secondary outcomes
Recurrence-free rate
Time frame: up to 6 months
Complete response rate
Time frame: up to 3 months
Recurrence-free rate
Time frame: up to 3 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Every 4 weeks up to 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dingwei Ye, PI principal investigator
Shanghai Fudan University Affiliated Tumor Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VB4-845 Injection in people with Non-Muscle Invasive Bladder Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Kong, CMO (0531-83129659, oliver.kong@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: up to 6 months). 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 26 Apr 2021.