Oncolytic virus injection for advanced bone and soft tissue tumors

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

This study is testing a new virus treatment for people with advanced bone and soft tissue tumors who haven't had success with other therapies to see if it can help shrink their tumors.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 16 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Yunying Medical Technology (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06171282 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a recombinant herpes simplex virus type 1, known as R130, in treating patients with advanced bone and soft tissue tumors. The study aims to enroll 9 participants who have either failed standard treatments or are unwilling to pursue further antitumor therapies. Participants will receive intratumoral injections of the oncolytic virus, and their responses will be monitored to assess the treatment's effectiveness. The trial is designed as an open-label, single-arm study, focusing on patients with measurable lesions suitable for this type of intervention.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 16 to 75 with advanced soft tissue sarcoma or bone neoplasms who have not responded to standard treatments.

Not a fit: Patients with contraindications to intratumoral injections or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with advanced bone and soft tissue tumors who have limited treatment choices.

How similar studies have performed: While oncolytic virus therapies are an emerging field, this specific approach using R130 is novel and has not been extensively tested in similar studies.

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.

Where this trial is running

Shanghai

• Shanghai General Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Pan Feng, MD

Conditions Osteosarcoma; Sarcoma; Soft Tissue Sarcoma; Bone Tumor; Oncolytic virus; Herpes simplex virus type 1; Immunotherapy