NMIBCPhase 1/2VG-INFUSE TriaNCT07505615
A Phase I-II Study of Novel Oncolytic Virus VG161 Via Intravesical Instillation for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
A Phase 1/2 study testing VG161 via Intravesical Instillation in people with NMIBC, run by Ding-Wei Ye at 1 site in China.
Trial summary
A Phase I-II Study of Novel Oncolytic Virus VG161 via Intravesical Instillation for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer (VG-INFUSE Trial) Background: The treatment of recurrent/refractory non-muscle-invasive bladder cancer (NMIBC), particularly BCG-unresponsive disease, remains a significant clinical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NMIBC
- What is being tested?
- VG161 via Intravesical Instillation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2021to 30 May 2023
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria for enrollment:
- Willing and able to provide written informed consent and to comply with the protocol.
- Age ≥ 18 years.
- Histologically or cytologically confirmed urothelial carcinoma of the bladder.
- Cystoscopically and pathologically (via biopsy) confirmed recurrence of non-muscle-invasive bladder cancer, with ≥ 3 prior recurrences.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
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- Life expectancy ≥ 3 months.
- Adequate hematologic and end-organ function within 4 weeks prior to the first study treatment, defined as follows:
- Hematologic (without transfusion or growth factor support within 14 days): Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelets (PLT) ≥ 75 × 10⁹/L; Hemoglobin (Hb) ≥ 90 g/L.
- Hepatic: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN for patients with known liver metastases).
- Renal: Serum creatinine (Cr) ≤ 1.5 × ULN and calculated creatinine clearance ≥ 50 mL/min (using the Cockcroft-Gault formula).
- Coagulation: Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; Prothrombin time (PT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 × ULN.
- For women of childbearing potential: negative serum or urine pregnancy test within 7 days prior to study entry, agreement to use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the last dose, and must be non-lactating. For men: agreement to use effective contraception during the study and for 6 months after the last dose.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Pregnant or lactating women.
- Major surgical procedure within 4 weeks prior to the first dose of the study drug, or anticipation of the need for a major surgical procedure (other than for diagnostic purposes) during the study.
- Prior anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy) within 4 weeks prior to the first dose of the study drug, with the following exceptions:
- Nitrosoureas or mitomycin C within 6 weeks prior.
- Oral fluoropyrimidines and small-molecule targeted agents within 2 weeks prior or within 5 half-lives of the drug (whichever is longer).
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- Traditional Chinese medicine with approved anti-tumor indications within 2 weeks prior.
- Treatment with systemic corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppressive agents within 14 days prior to the first dose. The following are allowed: use of topical, ocular, intra-articular, intranasal, or inhaled corticosteroids; short-term prophylactic use of corticosteroids (e.g., for contrast allergy prevention).
- Administration of a live, attenuated vaccine within 4 weeks prior to the first dose, or anticipation that such a vaccine will be required during the study.
- Severe infection within 4 weeks prior to the first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Significant cardiovascular disease, such as New York Heart Association Class II or greater heart disease, myocardial infarction within 3 months prior to enrollment, unstable arrhythmias, or unstable angina.
- Patients with uncontrolled type 1 diabetes mellitus. Patients with type 1 diabetes on a stable insulin regimen are eligible.
- Active hepatitis infection (defined as positive hepatitis B surface antigen [HBsAg] at screening) or hepatitis C. Patients with past or resolved HBV infection (defined as negative HBsAg and positive total hepatitis B core antibody [anti-HBc]) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- Evidence of significant uncontrolled concurrent illness that could affect compliance with the protocol or interpretation of results, including significant liver disease, positive HIV test, active tuberculosis, or a history of gastrointestinal conditions (medical or extensive surgery) that may interfere with drug absorption.
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- Known immediate or delayed hypersensitivity, intolerance, or contraindication to any component of the novel oncolytic virus formulation.
- Negative test results for both Type 1 Herpes Simplex Virus IgG and IgM antibodies.
- Active recurrent herpes simplex virus infection with corresponding clinical manifestations (e.g., herpes labialis, herpes keratitis, herpes dermatitis, genital herpes) at the time of screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center, ShangHai,
Shanghai, Shanghai Municipality, 200032
About this study
A Phase I-II Study of Novel Oncolytic Virus VG161 via Intravesical Instillation for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer (VG-INFUSE Trial)
Background: The treatment of recurrent/refractory non-muscle-invasive bladder cancer (NMIBC), particularly BCG-unresponsive disease, remains a significant clinical challenge. Oncolytic virotherapy represents a promising novel therapeutic strategy. This study aims to evaluate the safety, preliminary efficacy, and biological activity of VG161, a novel oncolytic virus, administered via intravesical instillation.
Read more
Methods: This is a single-arm, prospective Phase I-II clinical trial conducted at Fudan University Shanghai Cancer Center, led by Drs. Zhang Hailiang and Ye Dingwei. Over an estimated duration of 2 years, 8 to 24 patients with recurrent/refractory NMIBC will be enrolled. The primary objectives are to assess the safety profile, identify the maximum tolerated dose (MTD), and determine the recommended Phase II dose (RP2D) of intravesical VG161. Preliminary efficacy will be evaluated based on recurrence-free survival (RFS) per RECIST 1.1. Key secondary and exploratory objectives include characterizing the pharmacokinetics (PK) and viral shedding profile in urine and blood; investigating pharmacodynamic immune responses and potential predictive biomarkers (e.g., via high-throughput sequencing of the tumor microenvironment, CyTOF, and multiplex immunohistochemistry); and analyzing dynamic changes in peripheral immune cell phenotypes and circulating tumor DNA (ctDNA).
Expected Outcomes: This trial will define the safety, tolerability, and preliminary clinical activity of intravesical VG161. Furthermore, it will provide crucial insights into its PK profile, mechanism of action, and correlative biomarkers, which will inform subsequent clinical development for BCG-unresponsive bladder cancer.
- Conditions
- NMIBC
- Being tested
- VG161 via Intravesical Instillation
- 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.
VG161 via Intravesical InstillationDrug
This trial will define the safety, tolerability, and preliminary clinical activity of intravesical VG161. Furthermore, it will provide crucial insights into its PK profile, mechanism of action, and correlative biomarkers, which will inform subsequent clinical development for BCG-unresponsive bladder cancer.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | This is a single-arm, prospective Phase I-II clinical trial conducted at Fudan University Shanghai Cancer Center. Over an estimated duration of 2 years, 8 to 24 patients with recurrent/refractory NMIBC will be enrolled. The primary objectives are to assess the safety profile, identify the maximum tolerated dose (MTD), and determine the recommended Phase II dose (RP2D) of intravesical VG161. Preliminary efficacy will be evaluated based on recurrence-free survival (RFS) per RECIST 1.1. Key secondary and exploratory objectives include characterizing the pharmacokinetics (PK) and viral shedding profile in urine and blood; investigating pharmacodynamic immune responses and potential predictive biomarkers (e.g., via high-throughput sequencing of the tumor microenvironment, CyTOF, and multiplex immunohistochemistry); and analyzing dynamic changes in peripheral immune cell phenotypes and circulating tumor DNA (ctDNA). Receives: Drug: VG161 via Intravesical Instillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival
Relapse-Free Survival (RFS) is defined as the length of time from the date of enrollment to the date of first documented disease relapse (recurrence)
Measured: 12 months from last participant enrolled
Incidence of treatment-related adverse events (TRAEs)
Adverse events judged to be related to trial drug according to CTCAE v5.0 criteria occurred from the first dose to 30 days after the last dose.
Measured: 12 months from last participant enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start12 Oct 2021
- Primary completion28 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMIBCStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- This is a single-arm, prospective Phase I-II clinical trial conducted at Fudan University Shanghai Cancer Center. Over an estimated duration of 2 years, 8 to 24 patients with recurrent/refractory NMIBC will be enrolled. The primary objectives are to assess the safety profile, identify the maximum tolerated dose (MTD), and determine the recommended Phase II dose (RP2D) of intravesical VG161. Preliminary efficacy will be evaluated based on recurrence-free survival (RFS) per RECIST 1.1. Key secondary and exploratory objectives include characterizing the pharmacokinetics (PK) and viral shedding profile in urine and blood; investigating pharmacodynamic immune responses and potential predictive biomarkers (e.g., via high-throughput sequencing of the tumor microenvironment, CyTOF, and multiplex immunohistochemistry); and analyzing dynamic changes in peripheral immune cell phenotypes and circulating tumor DNA (ctDNA).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ding-Wei Ye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ding-Wei Ye, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505615
- Sponsor's protocol ID
- MNWKrbd-ZHL
- Acronym
- VG-INFUSE Tria
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study of Novel Oncolytic Virus VG161 Via Intravesical Instillation for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07505615
- Acronym / sponsor ID
- VG-INFUSE Tria / MNWKrbd-ZHL
- Conditions
- NMIBC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ding-Wei YeUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 1 Apr 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.
A Phase I-II Study of Novel Oncolytic Virus VG161 via Intravesical Instillation for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer (VG-INFUSE Trial)
Background: The treatment of recurrent/refractory non-muscle-invasive bladder cancer (NMIBC), particularly BCG-unresponsive disease, remains a significant clinical challenge. Oncolytic virotherapy represents a promising novel therapeutic strategy. This study aims to evaluate the safety, preliminary efficacy, and biological activity of VG161, a novel oncolytic virus, administered via intravesical instillation.
Methods: This is a single-arm, prospective Phase I-II clinical trial conducted at Fudan University Shanghai Cancer Center, led by Drs. Zhang Hailiang and Ye Dingwei. Over an estimated duration of 2 years, 8 to 24 patients with recurrent/refractory NMIBC will be enrolled. The primary objectives are to assess the safety profile, identify the maximum tolerated dose (MTD), and determine the recommended Phase II dose (RP2D) of intravesical VG161. Preliminary efficacy will be evaluated based on recurrence-free survival (RFS) per RECIST 1.1. Key secondary and exploratory objectives include characterizing the pharmacokinetics (PK) and viral shedding profile in urine and blood; investigating pharmacodynamic immune responses and potential predictive biomarkers (e.g., via high-throughput sequencing of the tumor microenvironment, CyTOF, and multiplex immunohistochemistry); and analyzing dynamic changes in peripheral immune cell phenotypes and circulating tumor DNA (ctDNA).
Expected Outcomes: This trial will define the safety, tolerability, and preliminary clinical activity of intravesical VG161. Furthermore, it will provide crucial insights into its PK profile, mechanism of action, and correlative biomarkers, which will inform subsequent clinical development for BCG-unresponsive bladder cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, prospective Phase I-II clinical trial conducted at Fudan University Shanghai Cancer Center. Over an estimated duration of 2 years, 8 to 24 patients with recurrent/refractory NMIBC will be enrolled. The primary objectives are to assess the safety profile, identify the maximum tolerated dose (MTD), and determine the recommended Phase II dose (RP2D) of intravesical VG161. Preliminary efficacy will be evaluated based on recurrence-free survival (RFS) per RECIST 1.1. Key secondary and exploratory objectives include characterizing the pharmacokinetics (PK) and viral shedding profile in urine and blood; investigating pharmacodynamic immune responses and potential predictive biomarkers (e.g., via high-throughput sequencing of the tumor microenvironment, CyTOF, and multiplex immunohistochemistry); and analyzing dynamic changes in peripheral immune cell phenotypes and circulating tumor DNA (ctDNA).
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: VG161 via Intravesical InstillationThis is a single-arm, prospective Phase I-II clinical trial conducted at Fudan University Shanghai Cancer Center. Over an estimated duration of 2 years, 8 to 24 patients with recurrent/refractory NMIBC will be enrolled. The primary objectives are to assess the safety profile, identify the maximum tolerated dose (MTD), and determine the recommended Phase II dose (RP2D) of intravesical VG161. Preliminary efficacy will be evaluated based on recurrence-free survival (RFS) per RECIST 1.1. Key secondary and exploratory objectives include characterizing the pharmacokinetics (PK) and viral shedding profile in urine and blood; investigating pharmacodynamic immune responses and potential predictive biomarkers (e.g., via high-throughput sequencing of the tumor microenvironment, CyTOF, and multiplex immunohistochemistry); and analyzing dynamic changes in peripheral immune cell phenotypes and circulating tumor DNA (ctDNA). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing and able to provide written informed consent and to comply with the protocol.
- Age ≥ 18 years.
- Histologically or cytologically confirmed urothelial carcinoma of the bladder.
- Cystoscopically and pathologically (via biopsy) confirmed recurrence of non-muscle-invasive bladder cancer, with ≥ 3 prior recurrences.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Key exclusion criteria (18 listed)
- Pregnant or lactating women.
- Major surgical procedure within 4 weeks prior to the first dose of the study drug, or anticipation of the need for a major surgical procedure (other than for diagnostic purposes) during the study.
- Prior anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy) within 4 weeks prior to the first dose of the study drug, with the following exceptions:
- Nitrosoureas or mitomycin C within 6 weeks prior.
- Oral fluoropyrimidines and small-molecule targeted agents within 2 weeks prior or within 5 half-lives of the drug (whichever is longer).
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 |
|---|---|---|
| VG161 via Intravesical InstillationThis trial will define the safety, tolerability, and preliminary clinical activity of intravesical VG161. Furthermore, it will provide crucial insights into its PK profile, mechanism of action, and correlative biomarkers, which will inform subsequent clinical development for BCG-unresponsive bladder cancer. | Drug | Treatment |
Primary outcome
Relapse-Free Survival
Time frame: 12 months from last participant enrolled
Relapse-Free Survival (RFS) is defined as the length of time from the date of enrollment to the date of first documented disease relapse (recurrence)
Incidence of treatment-related adverse events (TRAEs)
Time frame: 12 months from last participant enrolled
Adverse events judged to be related to trial drug according to CTCAE v5.0 criteria occurred from the first dose to 30 days after the last dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VG161 via Intravesical Instillation in people with NMIBC, run by Ding-Wei Ye 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 13 inclusion and 18 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: finished, as of the sponsor's last update on 1 Apr 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-Free Survival (time frame: 12 months from last participant enrolled). The study lists 2 primary outcomes in all. 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 1 Apr 2026.