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

NCT05830240 | Recruiting Early Phase 1

• 1 other identifier: SHWG-R130-HNC
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Esophageal Cancer; Otorhinolaryngologic Neoplasms; Ear Cancer; Nose Cancer; Laryngeal Cancer; Pharyngeal Cancer

Keywords

Oncolytic virus; Herpes simplex virus type 1

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Disease Assessment for Disease Control Rate

  Every 10 weeks for 12 months

• Disease Assessment for Duration of Response

  Every 10 weeks for 12 months

• Quality of Life Assessment

  Every 6 weeks for 12 months

Study Arms (1)

R130 Treatment Group

EXPERIMENTAL

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)

Interventions

Recombinant oncolytic herpes simplex virus type 1 (R130) DRUG

R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11

Also known as: Oncolytic virus

R130 Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Yunying Medical Technology: lead
• Eye & ENT Hospital of Fudan University: collaborator

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, 200000, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Esophageal Neoplasms; Otorhinolaryngologic Neoplasms; Ear Neoplasms; Nose Neoplasms; Laryngeal Neoplasms; Pharyngeal Neoplasms

Interventions

Oncolytic Virotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Skull Neoplasms; Bone Neoplasms; Bone Diseases; Musculoskeletal Diseases; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Laryngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Haitao Wu, Phd

  Eye & ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Pan, MD

CONTACT

+86 13764868528; pf@jxyymedtech.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 26, 2023
• Study Start: March 27, 2023
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2026
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)