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About
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.
Full 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.
Enrollment
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Inclusion criteria
Exclusion criteria
The investigator's concern that injecting the drug into the tumor mass may lead to life-threatening side effects, if tumor swelling or inflammation occurs after treatment;
History of hypersensitivity to ganciclovir, valganciclovir, or any other component of Cymeven®;
History of hypersensitivity to acyclovir or pencyclovir (or their prodrugs valacyclovir or famciclovir, respectively);
History of allergic reactions to antibiotics;
History of allergic reaction to polyethylene glycol or polyethyleneimine;
The following medications are scheduled to be taken during the potential therapy period:
Pregnancy or lactation;
Presence of primary multiple malignant diseases;
Presence of connection of the tumor mass with the main vessels according to ultrasound/CT/MRI data;
Radiation damage (ulceration, necrosis);
High risk/continued bleeding;
Systemic connective tissue disease (scleroderma, etc.);
Exacerbation of allergic diseases at the time of inclusion in the study;
Liver function disorder;
Presence of acute and acute chronic infections within the last 4 weeks before inclusion in the study (including tuberculosis, abscess, phlegmon);
Exacerbations of chronic diseases of the cardiovascular, bronchopulmonary, urogenital, gastrointestinal, musculoskeletal, nervous and immune systems at the time of inclusion in the study;
Presence of mental illness;
A history of active primary immunodeficiency;
Presence of HIV, active hepatitis B or C;
Brain metastases, carcinomatous meningitis at the moment of inclusion in the study;
Patient's participation in another clinical trial less than 30 days before inclusion in this study;
Any condition that, in the opinion of the investigator, might interfere with adequate treatment delivery, including difficult contact with the patient (inadequate perception of information provided about the patient's condition and planned/conducted treatment, refusal to comply with recommendations).
Primary purpose
Allocation
Interventional model
Masking
21 participants in 3 patient groups
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Central trial contact
Max Koksharov
Data sourced from clinicaltrials.gov
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