An Early Phase 1 interventional study of Recombinant oncolytic herpes simplex virus type 1 (R130) in Lung Cancer, Bronchial Cancer and Non Small Cell Lung Cancer, sponsored by Shanghai Yunying Medical Technology. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-02.
Sponsored by Shanghai Yunying Medical Technology · Early Phase 1, Interventional, and Treatment
24 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 advanced solid tumors.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Shanghai Yunying Medical Technology is the lead sponsor of 7 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Every 7-14 days,1-4 ml R130 (concentration of 1x10\^8 plaque-forming Units/mL,PFU/mL)will be injected intratumoral or intraperitoneal in patients with advanced solid tumors
Drug: Recombinant oncolytic herpes simplex virus type 1 (R130)
R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11
Also known as: Oncolytic virus
Subject 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)
Time frame: Up to 6 months
Subject incidence of laboratory abnormalities
Detection of liver and renal function, electrocardiogram, routine blood examination etc.
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
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
Time frame: Every 10 weeks for 12 months
Disease Assessment for Duration of Response
Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST
Time frame: Every 10 weeks for 12 months
Quality of Life Assessment
Evaluate with EORTC QLQ-C30
Time frame: Every 6 weeks for 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Shanghai Yunying Medical Technology