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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851456
• Other study ID #: XAHH-R130-BSTT
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 10, 2023
• Est. completion date: April 2026

Study information

• Verified date: April 2023
• Source: Shanghai Yunying Medical Technology
• Contact: Feng Pan, MD
• Phone: +8613764868528
• Email: pf[@]jxyymedtech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

20 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 bone and soft tissue tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 14 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.

Related Conditions & MeSH terms

• Bone Tumor
• Osteosarcoma
• Sarcoma
• Sarcoma,Soft Tissue
• Soft Tissue Neoplasms

Intervention

Drug:
• Recombinant oncolytic herpes simplex virus type ? (R130)
R130, a modified herpes simplex virus-? (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11

Locations

Country	Name	City	State
China	Xi'an Honghui Hospital	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Yunying Medical Technology	Xi'an Honghui Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject incidence of adverse events.	To characterize the safety profile of R130 injection in patients with relapsed/refractory bone and soft tissue tumors as measured by the incidence of Grade = 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)	Up to 6 months
Primary	Subject incidence of laboratory abnormalities	Detection of liver and renal function, electrocardiogram, routine blood examination etc.	Up to 1 month
Primary	Systemic Immune Response	Detection of increased systemic immune Response markers in sera (IL2,IL4,IL6,IL8,IL10,TNFa,IFN?, etc.) and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)	Up to 6 months
Secondary	Disease Assessment for Disease Control Rate	Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST	Every 10 weeks for 12 months
Secondary	Disease Assessment for Duration of Response	Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST	Every 10 weeks for 12 months
Secondary	Quality of Life Assessment	Evaluate with EORTC QLQ-C30	Every 6 weeks for 12 months