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NCT05077033: SmartGeneH&N
Intratumoral phIL12 GET
Phase 1 trial testing phIL12 GET in Basal Cell Carcinoma in 9 participants. Completed in 30 November 2023.
1 September 2023
Quick facts
| Lead sponsor | Institute of Oncology Ljubljana |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 28 September 2021 |
| Primary completion | 1 September 2023 |
| Estimated completion | 30 November 2023 |
| Sites | 2 locations across Slovenia |
Drugs / interventions tested
- phIL12 GET — full drug profile →
Conditions studied
- Basal Cell Carcinoma — all drugs for Basal Cell Carcinoma →
Sponsor
Institute of Oncology Ljubljana
Who can join
18 and older, any sex, with Basal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Electroporation provides non-viral gene delivery method for plasmid DNA. Its clinical application was already proven in preclinical and in clinical trial in treatment of melanoma skin metastases with plasmid coding IL-12, in USA. Intratumoral gene transfer of plasmid coding for IL-12 has proven safe end effective, having good local tumour control and some evidence indicates on abscopal effect. The EU directives recommend the use of plasmids without the gene for antibiotic resistance. For this purpose we constructed plasmid coding for IL-12 in accordance with the EU regulatory requirements. In the proposed study we intend to study the safety and tolerability of the constructed plasmid, phIL12, in treatment of basal cell carcinomas in patients with operable tumors in head and neck region. The study is designed as exploratory, dose escalating with the aim to determine the dose of plasmid that produces IL-12 expression in the tumours with best biological activity, infiltration of the immune cells and no toxicity.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Macrophage and monocyte subsets as new therapeutic targets in cancer immunotherapy.
Fendl B, Berghoff AS, Preusser M, Maier B. · · 2023 · cited 34× · PMID 36731326 · DOI 10.1016/j.esmoop.2022.100776 -
Treatment of skin tumors with intratumoral interleukin 12 gene electrotransfer in the head and neck region: a first-in-human clinical trial protocol.
Groselj A, Bosnjak M, Jesenko T, Cemazar M, et al · · 2022 · cited 22× · PMID 35535423 · DOI 10.2478/raon-2022-0021 -
Interleukin-12 Delivery Strategies and Advances in Tumor Immunotherapy.
Dong C, Tan D, Sun H, Li Z, et al · · 2024 · cited 18× · PMID 39451566 · DOI 10.3390/cimb46100686 -
Invasive and non-invasive electrodes for successful drug and gene delivery in electroporation-based treatments.
Malyško-Ptašinskė V, Staigvila G, Novickij V. · · 2022 · cited 6× · PMID 36727038 · DOI 10.3389/fbioe.2022.1094968 -
Safety and Efficacy of IL-12 Plasmid DNA Transfection into Pig Skin: Supportive Data for Human Clinical Trials on Gene Therapy and Vaccination.
Lampreht Tratar U, Jesenko T, Omerzel M, Seliskar A, et al · · 2024 · cited 3× · PMID 38542122 · DOI 10.3390/ijms25063151 -
Between defence and delivery: the DNA sensing response to gene electrotransfer.
Jesenko T, Omerzel M, Heller LC, Cemazar M. · · 2025 · PMID 41401059 · DOI 10.2478/raon-2025-0063
Verify or expand the search:
- PubMed search for NCT05077033
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05077033 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Oncology Ljubljana
- Last refreshed: 14 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05077033.
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