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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;