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A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Ovarian Cancer

Primary Purpose

Ovarian Cancer, Peritoneal Carcinomatosis, Fallopian Tube Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Recombinant oncolytic herpes simplex virus type 1 (R130)
Sponsored by
Shanghai Yunying Medical Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Oncolytic virus, Herpes simplex virus typeⅠ, Immunotherapy

Eligibility Criteria

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

Inclusion Criteria: Patients with ovarian cancer clearly diagnosed by histology and/or cytology. Failure of standard treatment or patient unwillingness to receive other antitumor therapy. Age 18 to 75 years. Subjects with ECoG score of 0-2. Expected survival of 3 months or more. Have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral or intraperitoneal drug delivery. Subjects must have appropriate organ function, and laboratory tests during the screening period must meet the following requirements: a) absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets (PLT) ≥ 80 × 109/L, and hemoglobin (Hb) ≥ 85 g/L; b) serum creatinine (Cr) and blood urea nitrogen (BUN) within 1.5 times the upper limit of normal values; c) serum c) serum total bilirubin (TBIL) ≤ 2 times the upper limit of normal values; d) glutamic aminotransferase (ALT) and glutamic oxalacetic aminotransferase (AST) ≤ 2.5 times the upper limit of normal values; subjects with liver metastases do not exceed 5 times the upper limit of normal values; e) activated partial thromboplastin time (APTT), prothrombin time (PT) within 1.5 times the upper limit of normal values. Any treatment for malignancy, including radiotherapy, chemotherapy and biological agents, must be discontinued 28 days prior to R130 treatment. Eligible patients of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for the duration of the trial and for at least 180 days after the last dose; female patients of childbearing potential must have a negative urine pregnancy test within 7 days prior to enrollment. Subjects voluntarily sign an informed consent form and are in good compliance. Exclusion Criteria: Have had any serious adverse reactions associated with immunotherapy. Subjects with any severe and/or uncontrolled disease, including: a) poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); b) suffering from class I or higher myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c) active or uncontrolled severe infection (≥ CTCAE grade 2 infection); d) Patients with previous organ transplantation, bone marrow transplantation (hematopoietic stem cell transplantation) and severe immune deficiency; e) Urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein quantification > 1.0 g. Patients with past history of type I diabetes mellitus or HIV. Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy. Patients with symptomatic primary or metastatic brain tumors. Patients with active tuberculosis and a strong positive OT test. Patients with active bleeding or severe coagulation dysfunction. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose. Have not recovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance. Patients who have undergone surgery of grade 3 or higher or whose surgical wounds have not healed within 4 weeks prior to enrollment. Participation in other clinical trials within four weeks prior to enrollment. Subjects who, in the judgment of the investigator, are unsuitable for participation in this trial for any reason.

Sites / Locations

  • Shanghai Tenth People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R130 Treatment Group

Arm Description

Every 7-14 days,1-4 ml R130 (concentration of 1x10^6-1x10^8 plaque-forming Units/mL,PFU/mL)will be injected intratumoral or Intraperitioneal in patients with relapsed/refractory ovarian cancer.

Outcomes

Primary Outcome Measures

Adverse Events
All serious and non-serious adverse events that occur after enrollment through 7 (+14) days after the last administration of R130 will be recorded
Systemic immune response
Detection of increased systemic immune Response markers in sera,ascites and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)

Secondary Outcome Measures

Disease Assessment for Disease Control Rate
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
Disease Assessment for Duration of Response
Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST
Quality of Life Assessment
Evaluate with EORTC QLQ-C30

Full Information

First Posted
March 26, 2023
Last Updated
March 26, 2023
Sponsor
Shanghai Yunying Medical Technology
Collaborators
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05801783
Brief Title
A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Ovarian Cancer
Official Title
A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
December 2, 2024 (Anticipated)
Study Completion Date
December 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Yunying Medical Technology
Collaborators
Shanghai 10th People's Hospital

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
10 participants are expected to be enrolled for this open,Single-armed clinical trial to evaluate the safety, tolerability, and efficacy of the recombinant herpes simplex virus I, R130 in patients with relapsed/refractory ovarian cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Carcinomatosis, Fallopian Tube Cancer
Keywords
Oncolytic virus, Herpes simplex virus typeⅠ, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
R130 Treatment Group
Arm Type
Experimental
Arm Description
Every 7-14 days,1-4 ml R130 (concentration of 1x10^6-1x10^8 plaque-forming Units/mL,PFU/mL)will be injected intratumoral or Intraperitioneal in patients with relapsed/refractory ovarian cancer.
Intervention Type
Drug
Intervention Name(s)
Recombinant oncolytic herpes simplex virus type 1 (R130)
Other Intervention Name(s)
Oncolytic virus Injection
Intervention Description
R130, a modified herpes simplex virus-1 (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11
Primary Outcome Measure Information:
Title
Adverse Events
Description
All serious and non-serious adverse events that occur after enrollment through 7 (+14) days after the last administration of R130 will be recorded
Time Frame
Up to 6 months
Title
Systemic immune response
Description
Detection of increased systemic immune Response markers in sera,ascites and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Disease Assessment for Disease Control Rate
Description
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
Time Frame
Every 10 weeks for 12 months
Title
Disease Assessment for Duration of Response
Description
Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST
Time Frame
Every 10 weeks for 12 months
Title
Quality of Life Assessment
Description
Evaluate with EORTC QLQ-C30
Time Frame
Every 6 weeks for 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ovarian cancer clearly diagnosed by histology and/or cytology. Failure of standard treatment or patient unwillingness to receive other antitumor therapy. Age 18 to 75 years. Subjects with ECoG score of 0-2. Expected survival of 3 months or more. Have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral or intraperitoneal drug delivery. Subjects must have appropriate organ function, and laboratory tests during the screening period must meet the following requirements: a) absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets (PLT) ≥ 80 × 109/L, and hemoglobin (Hb) ≥ 85 g/L; b) serum creatinine (Cr) and blood urea nitrogen (BUN) within 1.5 times the upper limit of normal values; c) serum c) serum total bilirubin (TBIL) ≤ 2 times the upper limit of normal values; d) glutamic aminotransferase (ALT) and glutamic oxalacetic aminotransferase (AST) ≤ 2.5 times the upper limit of normal values; subjects with liver metastases do not exceed 5 times the upper limit of normal values; e) activated partial thromboplastin time (APTT), prothrombin time (PT) within 1.5 times the upper limit of normal values. Any treatment for malignancy, including radiotherapy, chemotherapy and biological agents, must be discontinued 28 days prior to R130 treatment. Eligible patients of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for the duration of the trial and for at least 180 days after the last dose; female patients of childbearing potential must have a negative urine pregnancy test within 7 days prior to enrollment. Subjects voluntarily sign an informed consent form and are in good compliance. Exclusion Criteria: Have had any serious adverse reactions associated with immunotherapy. Subjects with any severe and/or uncontrolled disease, including: a) poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); b) suffering from class I or higher myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c) active or uncontrolled severe infection (≥ CTCAE grade 2 infection); d) Patients with previous organ transplantation, bone marrow transplantation (hematopoietic stem cell transplantation) and severe immune deficiency; e) Urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein quantification > 1.0 g. Patients with past history of type I diabetes mellitus or HIV. Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy. Patients with symptomatic primary or metastatic brain tumors. Patients with active tuberculosis and a strong positive OT test. Patients with active bleeding or severe coagulation dysfunction. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose. Have not recovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance. Patients who have undergone surgery of grade 3 or higher or whose surgical wounds have not healed within 4 weeks prior to enrollment. Participation in other clinical trials within four weeks prior to enrollment. Subjects who, in the judgment of the investigator, are unsuitable for participation in this trial for any reason.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Pan, MD
Phone
+86 13764868528
Email
pf@jxyymedtech.com
Facility Information:
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Guo, MD,PhD
Phone
+86 18817821547
Email
jguo12@foxmail.com
First Name & Middle Initial & Last Name & Degree
Zhongping Cheng, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Ovarian Cancer

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