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

Early Phase 1

Recruiting

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

• Registration Number: NCT05830240
• Lead Sponsor: Shanghai Yunying Medical Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-27
• Study First Submitted: 2023-03-31
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Primary Completion: 2025-03-27
• Study Completion: 2026-03-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R130 Treatment Group	Recombinant oncolytic herpes simplex virus type 1 (R130)	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

Primary Outcome Measures

Name	Time	Method
Systemic immune response	Up to 6 months	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)
Safety Profile Measured by Grade ≥3 CTCAE v5.0	Up to 6 months	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, China