Oncolytic virus injection for treating relapsed 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

This study is testing a new virus treatment for people with head and neck cancer that hasn't responded to other therapies to see if it can help them.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Yunying Medical Technology (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT05830240 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a recombinant oncolytic herpes simplex virus type 1 (R130) in patients with relapsed or refractory head and neck cancer. The study aims to enroll 9 participants who have failed standard treatments and have measurable lesions suitable for intratumoral drug delivery. It is an open-label, single-arm trial, focusing on patients aged 18 to 75 with specific health criteria. The primary goal is to assess how well this innovative treatment can work in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with relapsed or refractory head and neck cancer who have failed standard treatments.

Not a fit: Patients with severe functional failure of major organs or significant immunosuppression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat head and neck cancers.

How similar studies have performed: Other studies using oncolytic viruses have shown promise, suggesting potential for success in this novel approach.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Eye & ENT Hospital of Fudan University — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Haitao Wu, Phd — Eye & ENT Hospital of Fudan University
• Study coordinator: Feng Pan, MD

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