An Early Phase 1 interventional study of Recombinant oncolytic herpes simplex virus type Ⅰ (R130) in Cervical Cancer, Endometrial Cancer and Advanced Cancer, sponsored by Shanghai Yunying Medical Technology. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-14.
Sponsored by Shanghai Yunying Medical Technology · Early Phase 1, Interventional, and Treatment
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 Cervical and Endometrial Cancer.
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Shanghai Yunying Medical Technology is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
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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 Intraperitioneal in patients with relapsed/refractory cervical and endometrial Cancer.
Drug: Recombinant oncolytic herpes simplex virus type Ⅰ (R130)
Drug pages: Oncolytic HSV-1 R130 · Tetrachloroethane
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 Injection
Adverse Events
All serious and non-serious adverse events that occur after enrollment through 7 (+14) days after the last administration of R130 will be recorded
Time frame: Up to 6 months
Systemic immune response
Detection of increased systemic immune Response markers in sera,ascites 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: No
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Feb 2025, 24 months after the start.
Of 98 phase 1 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 100. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drugs tested here: Oncolytic HSV-1 R130 · Tetrachloroethane
Shanghai Yunying Medical Technology