Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid (NCT05578820) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid
Russia21 participantsStarted 2022-01-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Men and women aged 18-75;
✓. Histologically confirmed diagnosis of a solid tumor and/or its metastases: Sarcoma, Melanoma, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Penile Neoplasms, Anus Neoplasms
✓. Patients for whom surgery is not indicated;
✓. Patients with exhausted methods of drug and radiation therapy;
✓. Presence of clearly detectable and measurable by instrumental methods (ultrasound) tumor mass with a maximum size of at least 10 mm, palpable and accessible for intratumoral injection;
✓. The injected with the test drug tumor mass must not be located near large blood vessels or nerves;
✓. General health according to the ECOG scale 0-2;
✓. Life expectancy of at least 3 months;
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);
✕
What they're measuring
1
Safety (Presence/absence of dose-limiting toxicities (DLTs))
Timeframe: Through study completion, an average of 1 year
2
Safety (Frequency and severity of adverse events (CTCAE classification))
Timeframe: Through study completion, an average of 1 year
3
Safety (Number of cases of early termination of participation in the study due to the development of Serious Adverse Events and Other Adverse Events associated with the study therapy)
Timeframe: Through study completion, an average of 1 year
4
Pharmacokinetics (Quantitative content of plasmid DNA (pTKhGM) in patients' peripheral blood)
Timeframe: Through study completion, an average of 1 year
5
Pharmacokinetics (Quantitative content of plasmid DNA (pTKhGM) in patients' urine)
Timeframe: Through study completion, an average of 1 year