A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Advanced Bone and Soft Tissue Tumors

Launched by SHANGHAI YUNYING MEDICAL TECHNOLOGY · Dec 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with advanced bone and soft tissue tumors, specifically using a special type of virus called R130. The goal of the trial is to see how safe and effective this virus is for patients with conditions like osteosarcoma and sarcoma. The study will include nine participants aged 16 to 75 who have already tried standard treatments without success or are not willing to pursue other options. To qualify, patients should have a measurable tumor that can be treated directly with the virus and must meet certain health criteria.

Participants in the trial will receive the R130 virus injection and will be monitored for its effects on their tumors and overall health. They will need to stop any recent cancer treatments before starting the trial and agree to use reliable contraception if they are capable of becoming pregnant. This study is currently recruiting participants, and those who are interested should discuss it with their healthcare provider to see if they are eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 16 to 75 years, diagnosed with soft tissue sarcoma or bone neoplasms clearly by histology and/or cytology.
• • 2. Failure of standard treatment or patient unwillingness to receive other antitumor therapy.
• • 3. No absolute or relative centasis contraindiction.
• • 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 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 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 and have not recovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy.
• • 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 active tuberculosis and a strong positive OT test.
• • 6. Patients with active bleeding or severe coagulation dysfunction.
• • 7. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose.
• • 8. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance.
• • 9. Patients who have undergone surgery of grade 3 or higher or whose surgical wounds have not healed within 4 weeks prior to enrollment.
• • 10. Pregnant, lactating and planning to have children within six months.
• • 11. Subjects who, in the judgment of the investigator, are unsuitable for participation in this trial for any reason.