Overview

A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Advanced Solid Tumors

Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
0
Participant gender:
All
Summary
24 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 advanced solid tumors.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Yunying Medical Technology
Collaborator:
The PLA Navy Anqing Hospital
Criteria
Inclusion Criteria:

1. Patients with advanced solid tumors clearly diagnosed by histology and/or cytology.

2. Failure of standard treatment or patient unwillingness to receive other antitumor
therapy.

3. Age 18 to 75 years.

4. Subjects with ECOG score of 0-2.

5. Expected survival of 3 months or more.

6. Have at least one measurable lesion (according to RECIST 1.1 criteria) that is
amenable to intratumoral or intraperitoneal drug delivery.

7. Subjects must have appropriate organ function, and laboratory tests during the
screening period must meet the following requirements: a) absolute neutrophil count
(ANC) ≥ 1.5 × 109/L, platelets (PLT) ≥ 80 × 109/L, and hemoglobin (Hb) ≥ 85 g/L; b)
serum creatinine (Cr) and blood urea nitrogen (BUN) within 1.5 times the upper limit
of normal values; c) serum c) serum total bilirubin (TBIL) ≤ 2 times the upper limit
of normal values; d) glutamic aminotransferase (ALT) and glutamic oxalacetic
aminotransferase (AST) ≤ 2.5 times the upper limit of normal values; subjects with
liver metastases do not exceed 5 times the upper limit of normal values; e) activated
partial thromboplastin time (APTT), prothrombin time (PT) within 1.5 times the upper
limit of normal values.

8. Any treatment for malignancy, including radiotherapy, chemotherapy and biological
agents, must be discontinued 28 days prior to R130 treatment.

9. Eligible patients of childbearing potential must agree to use a reliable method of
contraception (hormonal or barrier method or abstinence) with their partner for the
duration of the trial and for at least 180 days after the last dose; female patients
of childbearing potential must have a negative urine pregnancy test within 7 days
prior to enrollment.

10. Subjects voluntarily sign an informed consent form and are in good compliance.

Exclusion Criteria:

1. Have had any serious adverse reactions associated with immunotherapy.

2. 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.

3. Patients with past history of type I diabetes mellitus or HIV.

4. Severe abnormalities in thyroid and cortisol testing; active, known or suspected
autoimmune disease requiring systemic therapy.

5. Patients with severe prior interstitial lung changes (as determined by the
investigator).

6. Patients with active tuberculosis and a strong positive OT test.

7. Patients with active bleeding or severe coagulation dysfunction.

8. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted
therapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose.

9. Have not recovered to CTCAE 4.0 grade rating 0 or 1 level of toxicity after previous
antineoplastic therapy.

10. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active
infection of clinical significance.

11. Patients who have undergone surgery of grade 3 or higher or whose surgical wounds have
not healed within 4 weeks prior to enrollment.

12. Pregnant, lactating and planning to have children within six months.

13. Subjects who, in the judgment of the investigator, are unsuitable for participation in
this trial for any reason.