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A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Relapsed/Refractory Head and Neck Cancer

Primary Purpose

Head and Neck Cancer, Esophageal Cancer, Otorhinolaryngologic Neoplasms

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 Head and Neck Cancer 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 head and neck cancer clearly diagnosed by histology and/or cytology, without systematic metastasis, and failure of standard treatment. Age 18 to 75 years. No absolute or relative centasis contraindiction,have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral drug delivery. No severe functinonal falure of heart, brain, liver, kidney and lung. Subjects with ECOG score of 0-2, and expected survival of 3 months or more. No evidence of clinically significant immunosuppression. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function during the screening period: White Blood Cell (WBC)≥3.0×10^9/L; Absolute Lymphocyte Count (ANC)≥1.5×10^9/L; Platelet≥100×10^9/L; Prothrombin time (PT) or activated Partial Thromboplastin Time(APTT)≤1.5×ULN; Serum Creatinine (Scr)≤1.5×ULN Alanine aminotransferase(AST/ALT) ≤3×ULN; Total Bilirubin(TBIL)≤1.5×ULN. Be able to understand and sign the informed consent document; Be able to stick to follow-up visit plan and other requirements in the agreement. Exclusion Criteria. With a history of allergy to similar drugs. With hematological diseases, malignant tumors of the central nervous system, or combined with other malignant tumors. pregnancy, breast feeding. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance. Impaired function of important organs or a history of organ transplantation. Receiving antiherpes simplex virus therapy such as acyclovir, ganciclovir, vancomycin, and acepromazine within 4 weeks. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy,4 weeks prior to the first dose. Have had any serious adverse reactions associated with immunotherapy and have not recovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy. 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. Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy. Patients with active bleeding or severe coagulation dysfunction. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

Sites / Locations

  • Eye & ENT Hospital of Fudan UniversityRecruiting

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 in patients with relapsed/refractory head and neck cancer

Outcomes

Primary Outcome Measures

Safety Profile Measured by Grade ≥3 CTCAE v5.0
To characterize the safety profile of R130 injection in patients with relapsed/refractory head and neck cancer as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)
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
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 31, 2023
Last Updated
April 13, 2023
Sponsor
Shanghai Yunying Medical Technology
Collaborators
Eye & ENT Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05830240
Brief Title
A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Relapsed/Refractory Head and Neck Cancer
Official Title
A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
March 27, 2025 (Anticipated)
Study Completion Date
March 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Yunying Medical Technology
Collaborators
Eye & ENT Hospital of Fudan University

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
9 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 relapsed/refractory head and neck cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Esophageal Cancer, Otorhinolaryngologic Neoplasms, Ear Cancer, Nose Cancer, Laryngeal Cancer, Pharyngeal 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
9 (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 in patients with relapsed/refractory head and neck cancer
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
Safety Profile Measured by Grade ≥3 CTCAE v5.0
Description
To characterize the safety profile of R130 injection in patients with relapsed/refractory head and neck cancer as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)
Time Frame
Up to 6 months
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
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
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 head and neck cancer clearly diagnosed by histology and/or cytology, without systematic metastasis, and failure of standard treatment. Age 18 to 75 years. No absolute or relative centasis contraindiction,have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral drug delivery. No severe functinonal falure of heart, brain, liver, kidney and lung. Subjects with ECOG score of 0-2, and expected survival of 3 months or more. No evidence of clinically significant immunosuppression. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function during the screening period: White Blood Cell (WBC)≥3.0×10^9/L; Absolute Lymphocyte Count (ANC)≥1.5×10^9/L; Platelet≥100×10^9/L; Prothrombin time (PT) or activated Partial Thromboplastin Time(APTT)≤1.5×ULN; Serum Creatinine (Scr)≤1.5×ULN Alanine aminotransferase(AST/ALT) ≤3×ULN; Total Bilirubin(TBIL)≤1.5×ULN. Be able to understand and sign the informed consent document; Be able to stick to follow-up visit plan and other requirements in the agreement. Exclusion Criteria. With a history of allergy to similar drugs. With hematological diseases, malignant tumors of the central nervous system, or combined with other malignant tumors. pregnancy, breast feeding. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance. Impaired function of important organs or a history of organ transplantation. Receiving antiherpes simplex virus therapy such as acyclovir, ganciclovir, vancomycin, and acepromazine within 4 weeks. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy,4 weeks prior to the first dose. Have had any serious adverse reactions associated with immunotherapy and have not recovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy. 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. Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy. Patients with active bleeding or severe coagulation dysfunction. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Pan, MD
Phone
+86 13764868528
Email
pf@jxyymedtech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haitao Wu, Phd
Organizational Affiliation
Eye & ENT Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haitao Wu, Ph.D
Phone
+86 18917785578
Email
eentwuhaitao@163.com
First Name & Middle Initial & Last Name & Degree
Jian Chen
Phone
+86 18917785406
Email
chenjent@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Relapsed/Refractory Head and Neck Cancer

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