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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Laryngeal Cancer; Otorhinolaryngologic Neoplasms; Esophageal Cancer; Ear Cancer; Nose Cancer; Pharyngeal Cancer
• Intervention / Treatment: Drug: Recombinant oncolytic herpes simplex virus type 1 (R130)

• Study Type: Interventional
• Enrollment (Anticipated): 9
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Feng Pan, MD; Phone Number: +86 13764868528; Email: pf@jxyymedtech.com

Study Locations

• China
  • Shanghai, China, 200000
    • Recruiting
    • Eye & ENT Hospital of Fudan University
    • Contact: Haitao Wu, Ph.D; Phone Number: +86 18917785578; Email: eentwuhaitao@163.com
    • Contact: Jian Chen; Phone Number: +86 18917785406; Email: chenjent@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with head and neck cancer clearly diagnosed by histology and/or cytology, without systematic metastasis, and failure of standard treatment.
2. Age 18 to 75 years.
3. 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.
4. No severe functinonal falure of heart, brain, liver, kidney and lung.
5. Subjects with ECOG score of 0-2, and expected survival of 3 months or more.
6. No evidence of clinically significant immunosuppression.

7. 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.
8. Be able to understand and sign the informed consent document;
9. Be able to stick to follow-up visit plan and other requirements in the agreement.

Exclusion Criteria.

1. With a history of allergy to similar drugs.
2. With hematological diseases, malignant tumors of the central nervous system, or combined with other malignant tumors.
3. pregnancy, breast feeding.
4. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance.
5. Impaired function of important organs or a history of organ transplantation.
6. Receiving antiherpes simplex virus therapy such as acyclovir, ganciclovir, vancomycin, and acepromazine within 4 weeks.
7. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy,4 weeks prior to the first dose.
8. 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.
9. 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.
10. Patients with past history of type I diabetes mellitus.
11. Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy.
12. Patients with active bleeding or severe coagulation dysfunction.
13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: R130 Treatment Group; 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	Drug: Recombinant oncolytic herpes simplex virus type 1 (R130); R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11; Other Names: Oncolytic virus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Up to 6 months
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)	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Assessment	Evaluate with EORTC QLQ-C30	Every 6 weeks for 12 months
Disease Assessment for Disease Control Rate	Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST	Every 10 weeks for 12 months
Disease Assessment for Duration of Response	Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST	Every 10 weeks for 12 months

Collaborators and Investigators

• Sponsor: Shanghai Yunying Medical Technology
• Collaborators: Eye & ENT Hospital of Fudan University
• Investigators: Principal Investigator: Haitao Wu, Phd, Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Anticipated): March 27, 2025
• Study Completion (Anticipated): March 27, 2026

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Oncolytic virus; Herpes simplex virus type 1
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Head and Neck Neoplasms; Laryngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms
• Other Study ID Numbers: SHWG-R130-HNC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No