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 advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11
Linyi Central Hospital
Linyi, Shandong, China
RECRUITINGSubject incidence of adverse events
To characterize the safety profile of R130 injection in patients with advanced solid tumors as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0),such as fever, fatigue, flu like symptoms, chills, Injection site reaction,etc.
Time frame: Up to 6 months
Subject incidence of laboratory abnormalities
Time frame: Up to 1 month
Systemic Immune Response
Detection of increased systemic immune Response markers in sera (IL2,IL4,IL6,IL8,IL10,TNFa,IFNγ, etc.) and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)
Time frame: Up to 6 months
Disease Assessment for Disease Control Rate
CT will be performed to evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST. DCR (proportion of patients) = with CR +PR +SD /CR + PR +SD + PD.
Time frame: Every 10 weeks for 12 months
Disease Assessment for Duration of Response
The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1
Time frame: Every 10 weeks for 12 months
Quality of Life Assessment
Comparison of patients' quality of life before and after R130 treatment as assessed by the EORTC QLQ-30 (V3.0).
Time frame: Every 6 weeks for 12 months
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