Clinical trial NCT05830240: 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
Overall status: RECRUITING
Phase: EARLY_PHASE1
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
Lead sponsor: Shanghai Yunying Medical Technology
Sponsor class: INDUSTRY
Collaborators: name: Eye & ENT Hospital of Fudan University
First posted: 2023-04-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety Profile Measured by Grade ≥3 CTCAE v5.0
timeFrame: Up to 6 months
measure: Systemic immune response
timeFrame: Up to 6 months
Secondary outcomes:
measure: Disease Assessment for Disease Control Rate
timeFrame: Every 10 weeks for 12 months
measure: Disease Assessment for Duration of Response
timeFrame: Every 10 weeks for 12 months
measure: Quality of Life Assessment
timeFrame: Every 6 weeks for 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
Study officials:
affiliation: Eye & ENT Hospital of Fudan University
name: Haitao Wu, Phd
role: PRINCIPAL_INVESTIGATOR
References: