Phase I trial of phIL12 plasmid intratumoral gene electrotransfer in patients with basal cell carcinoma in head and neck region

Strojan, Primož (author), Jesenko, Tanja (author), Omerzel, Maša (author), Jamšek, Črt (author), Grošelj, Aleš (author), Lampreht Tratar, Urša (author), Markelc, Boštjan (author), Gašljević, Gorana (author), Ihan, Alojz (author), Smrekar, Franc (author), Peterka, Matjaž (author), Čemažar, Maja (author), Serša, Gregor (author)

Introduction: In the treatment of cancer, immunomodulatory approaches are developed to support the organism in fighting cancer or to enhance the immunomodulatory effects of local ablative techniques. To this end, we conducted an interventional, open-label, single-arm Phase I trial to evaluate the safety and tolerability of intratumoral phIL12 plasmid DNA gene electrotransfer as primary objectives. Methods: The study was dose-escalating with 3 consecutive cohorts of 3 patients per phIL12 dose level (0.5 mg/ml, 1 mg/ml or 2 mg/ml) according to a matched 3 + 3 design. Recruitment of patients was staggered. The waiting period was 30 days after treatment of the previous patient, based on the expected duration of acute and subacute toxicity. Results: The results of this phase I clinical trial in basal cell carcinoma demonstrated the feasibility and safety of the phIL12 plasmid by gene electrotransfer. We were able to demonstrate that phIL12 gene electrotransfer induced local IL-12 production, which was accompanied with IFN-γ expression. Triggering of the immune response was demonstrated by increased infiltration of immune cells and some antitumor effect. Based on these data, we would recommend the use of a concentration of 2 mg/ml of the plasmid in future trials. Conclusion: The trial lays the foundation for future Phase II clinical trials in which phIL12 gene electrotransfer is used in combination with local tumor-ablative approaches, such as electrochemotherapy or radiotherapy.

• Language: English
• Keywords: phase I clinical trial, phIL12 plasmid, interleukin-12, gene electrotransfer, basal cell carcinoma
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: MF - Faculty of Medicine; ZF - Faculty of Health Sciences; VF - Veterinary Faculty; BF - Biotechnical Faculty
• Publication status: Published
• Publication version: Version of Record
• Year: 2025
• Number of pages: 10 str.
• Numbering: Vol. 51, iss. 5, art. 109574
• PID: 20.500.12556/RUL-166725
• UDC: 616-006
• ISSN on article: 1532-2157
• DOI: 10.1016/j.ejso.2025.109574
• COBISS.SI-ID: 223496195
• Publication date in RUL: 23.01.2025

Record is a part of a journal

• Title: European journal of surgical oncology
• Shortened title: Eur. j. surg. oncol.
• Publisher: Elsevier
• ISSN: 1532-2157
• COBISS.SI-ID: 59529475

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

• Language: Slovenian
• Keywords: onkologija, karcinom, glava, vrat