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OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer

Primary Purpose

Advanced Bladder Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
OH2 injection
Sponsored by
Binhui Biopharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Bladder Carcinoma focused on measuring Oncolytic Virus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OH2

Arm Description

OH2 dosage: 1x10e7 CCID50/mL Administration:intratumoral injection Frequency:once two weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Disease Control Rate
The assessment result is the number and proportion of subjects with complete response + partial response + stable disease.
Progression-Free Survival
Time after OH2 administration to clinical and radiographic disease progression will be evaluated.
Overall Survival
The overall survival for each patient receiving OH2 will be calculated

Full Information

First Posted
January 27, 2022
Last Updated
August 5, 2022
Sponsor
Binhui Biopharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05248789
Brief Title
OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer
Official Title
Efficacy and Safety Study of Oncolytic Virus (OH2) Intratumoral Injection in Locally Advanced or Metastatic Bladder Cancer a Phase Ⅱ Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Binhui Biopharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Bladder Carcinoma
Keywords
Oncolytic Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OH2
Arm Type
Experimental
Arm Description
OH2 dosage: 1x10e7 CCID50/mL Administration:intratumoral injection Frequency:once two weeks
Intervention Type
Biological
Intervention Name(s)
OH2 injection
Intervention Description
OH2: Oncolytic Type 2 Herpes Simplex Virus
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
The assessment result is the number and proportion of subjects with complete response + partial response.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disease Control Rate
Description
The assessment result is the number and proportion of subjects with complete response + partial response + stable disease.
Time Frame
2 years
Title
Progression-Free Survival
Description
Time after OH2 administration to clinical and radiographic disease progression will be evaluated.
Time Frame
2 years
Title
Overall Survival
Description
The overall survival for each patient receiving OH2 will be calculated
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.). 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaogang Wang, MD
Phone
13367255851
Email
sgwangtjm@163.com
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaogang Wang, MD
Phone
13367255851
Email
sgwangtjm@163.com

12. IPD Sharing Statement

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OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer

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