Oncolytic viral therapy for advanced bladder cancer

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

This study tests if a new virus treatment can help people with advanced bladder cancer by boosting their immune response and improving their health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Binhui Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05248789 on ClinicalTrials.gov

What this trial studies

This phase Ⅱ study evaluates the safety and efficacy of intratumoral injections of OH2, an oncolytic virus derived from herpes simplex virus type 2, in patients with locally advanced or metastatic bladder cancer. The treatment involves administering OH2 every two weeks, followed by monthly maintenance doses. The study will assess adverse events and treatment responses using established criteria and imaging techniques. The goal is to determine whether OH2 can effectively induce an antitumor immune response and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed advanced bladder cancer that has relapsed or metastasized after prior treatments.

Not a fit: Patients with early-stage bladder cancer or those who have not undergone prior anti-tumor treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel treatment option for patients with advanced bladder cancer who have limited alternatives.

How similar studies have performed: While oncolytic virus therapies are an emerging field, this specific approach using OH2 is novel and has not been extensively tested in previous studies.

Eligibility criteria

Inclusion Criteria:

1. Agree to sign informed consent, willing to follow the study procedures.
2. Age 18 \~ 75 years old (including boundary value), male or female.
3. ECOG 0-1.
4. Histologically or cytologically confirmed advanced bladder cancer，relapsed and metastasized after radiotherapy or immunotherapy.
5. Life expectancy \>12 weeks.
6. Agree to provide last surgical specimens (including paraffin blocks, paraffin embedded sections, etc.).
7. At least 6 weeks after previous anti-tumor treatment (radiotherapy, chemotherapy and immunotherapy) and the first administration of this trial.
8. 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).
9. Agree to take effective contraceptive measures during treatment and at least 180 days after the last treatment.

Exclusion Criteria:

1. The primary tumor was upper urinary tract and ureteral urothelial carcinoma.
2. 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.
3. 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.
4. Expected to have major surgery during the study period or had major surgery within 4 weeks before administration.
5. Received other vaccines within 30 days before the first administration (including new crown vaccine)
6. 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.
7. Human immunodeficiency virus (HIV) seropositive or history of HIV infection or other acquired immunodeficiency diseases.
8. 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).
9. Uncontrolled systemic diseases, such as cardiovascular and cerebrovascular diseases and diabetes.
10. History of organ transplantation or stem cell transplantation.
11. Cardiac insufficiency (patients classified as III-IV according to NY-HA of New York Heart Association).
12. Lung disease (such as shortness of breath during rest or slight activity or oxygen supplement for any reason).
13. Other basic diseases which would interfere with the diagnosis of the disease, or might potentially cause serious complications
14. Other serious infections before administration
15. Alcohol addicts or history of drug abuse.
16. History of neurological or mental disorders, such as epilepsy, dementia, poor compliance, or peripheral nervous system disorders.
17. Pregnancy or lactation, or expected pregnancy or childbirth during the trial period.
18. 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.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Shaogang Wang, MD

Conditions Advanced Bladder Carcinoma; Oncolytic Virus