Trials / Completed
CompletedNCT05578820
Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Gene Surgery LLC · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Sarcoma
- Melanoma
- Squamous Cell Carcinoma of Head and Neck
- Breast Neoplasms
- Uterine Cervical Neoplasms
- Vulvar Neoplasms
- Penile Neoplasms
- Anus Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Stimotimagene copolymerplasmid | Gene therapy drug, Intratumoral administration |
| DRUG | Ganciclovir | Antiviral drug, Intravenous administration |
Timeline
- Start date
- 2022-01-01
- Primary completion
- 2024-04-11
- Completion
- 2024-04-11
- First posted
- 2022-10-13
- Last updated
- 2024-07-01
Locations
4 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT05578820. Inclusion in this directory is not an endorsement.