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

Launched by SHANGHAI YUNYING MEDICAL TECHNOLOGY · Jul 25, 2023

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ClinConnect Summary

This clinical trial is studying a new treatment for patients with advanced solid tumors, which are cancers that form in tissues like bones, muscles, and organs. The treatment involves injecting a modified virus called R130, which is designed to attack and kill cancer cells. The trial is open to 20 participants aged between 18 and 75 who have been diagnosed with specific types of cancer, like sarcoma, breast cancer, and lung cancer, and who have not responded to standard treatments or prefer not to pursue them.

Participants in this trial can expect to receive the injection of the virus and will be closely monitored for safety and effectiveness. To be eligible, patients must have at least one measurable tumor that can be treated with the injection and must be in relatively good health, with expected survival of three months or more. It is important to note that certain health issues may disqualify someone from participating, such as severe uncontrolled diseases or recent treatments for cancer. If you or a loved one is interested in this trial, it may offer a new option for treatment, but it's essential to discuss it thoroughly with your healthcare team.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with 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. No absolute or relative centasis contraindiction.
• • 9. Eligible patients of childbearing potential must agree to use a reliable method of contraception 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.