Oncolytic virus injection for advanced solid tumors

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

This study is testing an injection of a special virus to see if it can help people with advanced solid tumors who have run out of other treatment options.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Yunying Medical Technology (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Jiangsu)
• Trial ID: NCT05860374 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of R130, a recombinant oncolytic herpes simplex virus type 1, in patients with advanced solid tumors. It is an open-label, single-arm study aiming to enroll 20 participants who have either failed standard treatments or are unwilling to pursue further antitumor therapies. Eligible patients must have measurable lesions suitable for intratumoral or intraperitoneal delivery of the virus. The trial will assess the impact of the treatment on tumor response and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced solid tumors that have been histologically or cytologically diagnosed and are amenable to treatment with R130.

Not a fit: Patients with early-stage tumors or those who have not yet received standard treatment 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 solid tumors who have limited treatment alternatives.

How similar studies have performed: While the use of oncolytic viruses in cancer treatment is an emerging field, similar studies have shown promising results, indicating potential for success in this approach.

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.

Where this trial is running

Shanghai, Jiangsu

• Xuzhou Second People's Hospital — Shanghai, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Feng Pan, MD

Conditions: Sarcoma, Carcinoma, Breast Cancer, Pancreatic Cancer, Colorectal Cancer, Gastric Cancer, Liver Cancer, Lung Cancer