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Advanced Bladder CarcinomaPhase 2NCT05248789

OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer

A Phase 2 study testing OH2 injection in people with Advanced Bladder Carcinoma, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This Ⅱ study evaluates the safety and efficacy of intratumoral injection of OH2 in locally advanced or metastatic bladder cancer. OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Bladder Carcinoma
What is being tested?
OH2 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteChina
Study dates
25 May 2022to 28 Oct 2024
Phase
Phase 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Agree to sign informed consent, willing to follow the study procedures.
  • Age 18 ~ 75 years old (including boundary value), male or female.
  • ECOG 0-1.
  • Histologically or cytologically confirmed advanced bladder cancer，relapsed and metastasized after radiotherapy or immunotherapy.
  • Life expectancy >12 weeks.
  • Agree to provide last surgical specimens (including paraffin blocks, paraffin embedded sections, etc.).
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  • At least 6 weeks after previous anti-tumor treatment (radiotherapy, chemotherapy and immunotherapy) and the first administration of this trial.
  • Appropriate organ function and hematopoietic function: neutrophil count (neut ≥ 1.5 × 109/L； White blood cell count (WBC) ≥ 3.0 × 109/L； Platelet count ≥ 100 × 109/L； Hemoglobin ≥ 90g / L; Serum creatinine ≤ 1.5 times the upper limit of normal value (ULN); AST and alt ≤ 2.5 times ULN; Serum total bilirubin ≤ 1.5 times ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN (except for patients undergoing anticoagulant therapy).
  • Agree to take effective contraceptive measures during treatment and at least 180 days after the last treatment.

Who cannot join

  • The primary tumor was upper urinary tract and ureteral urothelial carcinoma.
  • Malignant tumors other than bladder urothelial carcinoma within 5 years before enrollment.
  • except:
  • ①Prostate cancer with local low risk (stage ≤ T2b, Gleason score ≤ 7, PSA ≤ 20ng / ml, no recurrence after treatment (judged by reviewing PSA level)).
  • ②Low risk prostate cancer (stage T1 / T2a, Gleason score ≤ 7, and PSA ≤ 10NG / ml, in the observed but untreated stage.
  • ③For malignant tumors that meet other inclusion criteria but have a very low risk of metastasis or death, after standard treatment, recheck the patients whose imaging and disease-specific tumor markers show no recurrence or metastasis, such as fully treated cervical cancer in situ, basal or squamous cell skin cancer; Ductal carcinoma in situ after treatment and operation.
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  • Active autoimmune diseases and need systemic treatment in the past two years (i.e. long-term use of corticosteroids or immunosuppressive drugs). Alternative therapies (such as thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are excluded.
  • Expected to have major surgery during the study period or had major surgery within 4 weeks before administration.
  • Received other vaccines within 30 days before the first administration (including new crown vaccine)
  • Any immune related toxicity caused by previous cancer treatment did not return to ≤ grade 1 (except for grade 2 endocrine system diseases receiving stable dose hormone replacement therapy), and / or any other toxicity related to previous anti-cancer treatment (except immune related toxicity) did not return to ≤ grade 2, except hair loss.
  • Human immunodeficiency virus (HIV) seropositive or history of HIV infection or other acquired immunodeficiency diseases.
  • Long-term use of antiviral drugs, including hepatitis B (HBsAg positive and HBV DNA equal to 2000 IU/ml at the same time, and excluding hepatitis or other causes of hepatitis), hepatitis C (at the same time to meet the anti HCV antibody positive, and HCV-RNA fruit is greater than the lower limit).
  • Uncontrolled systemic diseases, such as cardiovascular and cerebrovascular diseases and diabetes.
  • History of organ transplantation or stem cell transplantation.
  • Cardiac insufficiency (patients classified as III-IV according to NY-HA of New York Heart Association).
  • Lung disease (such as shortness of breath during rest or slight activity or oxygen supplement for any reason).
  • Other basic diseases which would interfere with the diagnosis of the disease, or might potentially cause serious complications
  • Other serious infections before administration
  • Alcohol addicts or history of drug abuse.
  • History of neurological or mental disorders, such as epilepsy, dementia, poor compliance, or peripheral nervous system disorders.
  • Pregnancy or lactation, or expected pregnancy or childbirth during the trial period.
  • Allergic to study drug or have a history of allergic reaction to the main and auxiliary materials of any dosage form in the study drug.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

Other trials in China

About this study

Official title: Efficacy and Safety Study of Oncolytic Virus (OH2) Intratumoral Injection in Locally Advanced or Metastatic Bladder Cancer a Phase Ⅱ Clinical Trial

This Ⅱ study evaluates the safety and efficacy of intratumoral injection of OH2 in locally advanced or metastatic bladder cancer.

OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.

Read the detailed description

This is a phase Ⅱ study evaluating the efficacy and safety of OH2 in locally advanced or metastatic bladder cancer.

BH-OH2-017 is a single-arm,multicenter clinical trial. The OH2 injection will be delivered once two weeks. In the maintenance treatment period, OH2(1x10e7 CCID50/mL) will be delivered once a month.

Adverse events (AEs) are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).

Radiographic imaging studies are performed using computed tomography or magnetic resonance imaging. Measurement of cutaneous or subcutaneous lesions are conducted with calipers. Evaluation of response are performed by the investigators using both the RECIST version 1.1 and the iRECIST criteria.

Being tested
OH2 injection
Keywords
Oncolytic Virus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OH2 injectionBiological

    OH2: Oncolytic Type 2 Herpes Simplex Virus

Study groups in NCT05248789
Study groupRoleWhat they receive
OH2ExperimentalOH2 dosage: 1x10e7 CCID50/mL Administration：intratumoral injection Frequency：once two weeks
Receives: Biological: OH2 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    The assessment result is the number and proportion of subjects with complete response + partial response.

    Measured: 2 years

Secondary outcomes (3)

  1. Disease Control Rate

    The assessment result is the number and proportion of subjects with complete response + partial response + stable disease.

    Measured: 2 years

  2. Progression-Free Survival

    Time after OH2 administration to clinical and radiographic disease progression will be evaluated.

    Measured: 2 years

  3. Overall Survival

    The overall survival for each patient receiving OH2 will be calculated

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2022
  2. Study start25 May 2022
  3. Primary completion28 Oct 2024
  4. Study completion28 Oct 2024

Why it stopped: Strategy adjustment

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05248789
Sponsor's protocol ID
BH-OH2-017
Status last verified
Aug 2024
First submitted
27 Jan 2022
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OH2 injection in people with Advanced Bladder Carcinoma, run by Binhui Biopharmaceutical 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 9 inclusion and 22 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: stopped early, as of the sponsor's last update on 3 Aug 2025. 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 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 was stopped early (reason given: Strategy adjustment). Results are not available in the source record.

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?

Objective Response Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05248789.

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 3 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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