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A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors

Primary Purpose

Sarcoma, Carcinoma, Digestive 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 Sarcoma focused on measuring Oncolytic virus, Herpes simplex virus type 1

Eligibility Criteria

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

Inclusion Criteria: Patients with solid tumors 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. No absolute or relative centasis contraindiction. Eligible patients of childbearing potential must agree to use a reliable method of contraception 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 severe prior interstitial lung changes (as determined by the investigator). 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 4.0 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. Pregnant, lactating and planning to have children within six months. Subjects who, in the judgment of the investigator, are unsuitable for participation in this trial for any reason.

Sites / Locations

  • Linyi Central HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R130 Treatment Group

Arm Description

Every 7-14 days,1-2 ml R130 (concentration of 1x10^8 plaque-forming Units/mL,PFU/mL)will be injected intratumoral or intraperitoneal in patients with advanced solid tumors

Outcomes

Primary Outcome Measures

Subject incidence of adverse events
To characterize the safety profile of R130 injection in patients with advanced solid tumors as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0),such as fever, fatigue, flu like symptoms, chills, Injection site reaction,etc.
Subject incidence of laboratory abnormalities
Systemic Immune Response
Detection of increased systemic immune Response markers in sera (IL2,IL4,IL6,IL8,IL10,TNFa,IFNγ, etc.) and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)

Secondary Outcome Measures

Disease Assessment for Disease Control Rate
CT will be performed to evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST. DCR (proportion of patients) = with CR +PR +SD /CR + PR +SD + PD.
Disease Assessment for Duration of Response
The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1
Quality of Life Assessment
Comparison of patients' quality of life before and after R130 treatment as assessed by the EORTC QLQ-30 (V3.0).

Full Information

First Posted
July 18, 2023
Last Updated
July 25, 2023
Sponsor
Shanghai Yunying Medical Technology
Collaborators
Linyi Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05961111
Brief Title
A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors
Official Title
An Open, Single-armed, Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Yunying Medical Technology
Collaborators
Linyi Central Hospital

4. Oversight

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

5. Study Description

Brief Summary
20 participants are expected to be enrolled for this open,Single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with advanced solid tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Carcinoma, Digestive Cancer, Breast Cancer, Lung Cancer, Brain Cancer, Melanoma, Gynecologic Cancer, Head and Neck Cancer, Kidney Cancer
Keywords
Oncolytic virus, Herpes simplex virus type 1

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
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
R130 Treatment Group
Arm Type
Experimental
Arm Description
Every 7-14 days,1-2 ml R130 (concentration of 1x10^8 plaque-forming Units/mL,PFU/mL)will be injected intratumoral or intraperitoneal in patients with advanced solid tumors
Intervention Type
Drug
Intervention Name(s)
Recombinant oncolytic herpes simplex virus type 1 (R130)
Other Intervention Name(s)
Oncolytic virus
Intervention Description
R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11
Primary Outcome Measure Information:
Title
Subject incidence of adverse events
Description
To characterize the safety profile of R130 injection in patients with advanced solid tumors as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0),such as fever, fatigue, flu like symptoms, chills, Injection site reaction,etc.
Time Frame
Up to 6 months
Title
Subject incidence of laboratory abnormalities
Time Frame
Up to 1 month
Title
Systemic Immune Response
Description
Detection of increased systemic immune Response markers in sera (IL2,IL4,IL6,IL8,IL10,TNFa,IFNγ, etc.) 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
CT will be performed to evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST. DCR (proportion of patients) = with CR +PR +SD /CR + PR +SD + PD.
Time Frame
Every 10 weeks for 12 months
Title
Disease Assessment for Duration of Response
Description
The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1
Time Frame
Every 10 weeks for 12 months
Title
Quality of Life Assessment
Description
Comparison of patients' quality of life before and after R130 treatment as assessed by the EORTC QLQ-30 (V3.0).
Time Frame
Every 6 weeks for 12 months

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: Patients with solid tumors 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. No absolute or relative centasis contraindiction. Eligible patients of childbearing potential must agree to use a reliable method of contraception 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 severe prior interstitial lung changes (as determined by the investigator). 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 4.0 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. Pregnant, lactating and planning to have children within six months. 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
Phone
+8613764868528
Email
pf@jxyymedtech.com
Facility Information:
Facility Name
Linyi Central Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiliang Zhang
Phone
+86 13954939557
Email
Zpl@souhu.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors

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