Spots Global Cancer Trial Database for Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid
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Trial Identification
Brief Title: Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid
Official Title: An Open Multicenter Study of the Safety, Tolerability, and Pharmacokinetics of Different Doses of Stimotimagene Copolymerplasmid at Patients With Advanced-stage Solid Tumors With Cymeven® (Ganciclovir) Infusions
Study ID: NCT05578820
Study Description
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of different doses and administration regimens of Stimotimagene copolymerplasmid in patients with histologically confirmed diagnosis of solid tumor and/or its metastases.
Detailed Description: Stimotimagene copolymerplasmid is an anti-tumor gene therapy drug, contains super-coiled plasmid DNA encapsulated in polycationic envelope (PPT: polyethyleneimine (PEI) - polyethylene glycol (PEG) - TAT peptide). The plasmid encodes two therapeutic genes: herpes simplex virus thymidine kinase (HSVtk) and human granulocyte-macrophage colony-stimulating factor (hGM-CSF). HSVtk converts the prodrug ganciclovir to a toxin in cells that have been transfected by Stimotimagene copolymerplasmid, GM-CSF stimulates proliferation and differentiation of antigen-presenting cells. Stimotimagene copolymerplasmid therapy is two-staged: (1) intratumoral injection of Stimotimagene copolymerplasmid, (2) intravenous administration of ganciclovir (Cimeven®) This is the first-in-human study of Stimotimagene copolymerplasmid which will be conducted in three arms. In this study dose escalation (Arm1) and number of drug administrations (Arms 2 and 3) will be explored. All study parts will investigate the safety, tolerability and pharmacokinetic profile of Stimotimagene copolymerplasmid.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GBUZ Moscow Clinical Scientific Center named after Loginov MHD, Moscow, , Russian Federation
FSBI N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of Russia, Moscow, , Russian Federation
FSBI National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov of the Ministry of Health of Russia, Moscow, , Russian Federation
National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation, Moscow, , Russian Federation
Contact Details
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