NCT02531425

Evaluation of Pharmacodynamic Effects of IT-pIL12-EP in Patients With TNBC

Evaluation of Pharmacodynamic Effects of Intratumoral Delivery of Plasmid IL-12 Electroporation in Patients With Triple Negative Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: OncoSec Medical Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Intratumoral plasmid IL-12 electroporation (IT-pIL12-EP) will be administered to approximately 10 patients with triple negative breast cancer (TNBC) with cutaneous or subcutaneous disease. Patients will receive one complete cycle of therapy, consisting of local injection of plasmid IL-12 (pIL-12) followed immediately by electroporation (EP), into accessible tumor lesions. IT-pIL12-EP will be administered in Days 1, 5, and 8 of the single 28-day cycle.

Detailed description

This pilot study will evaluate the pharmacodynamic effects of intratumoral injection of pIL-12 followed immediately by electroporation (IT-pIL12-EP). A minimum of ten patients with biopsy-accessible triple negative breast cancer (TNBC) will be treated in this study. Additional patients, up to a maximum of 25 patients, may be enrolled based upon pharmacodynamic observations and at the discretion of the Principal Investigator, in consultation with the Sponsor. All patients will receive a single 28-day treatment cycle. One lesion will remain untreated (the control lesion). Treatment will be administered on Days 1,5, and 8 of the single 28-day cycle. Treatments will consist of direct injection of pIL-12 into tumor lesions, followed immediately by electroporation of the lesions. At the end of the treatment cycle, patients will return to clinic for a final safety evaluation and tumor biopsy. This end of study (EOS) visit will occur prior to initiating any new anti-cancer therapy/regimen. All patients will undergo tumor biopsies at two separate timepoints for molecular and histological analyses associated with the primary endpoint. At least one lesion will be biopsied at Screening (pre-treatment sample). Biopsies of the untreated control lesion and at least one treated lesion will be obtained at the EOS visit (post-treatment samples). Additional tumor biopsy samples may be requested if there is either tumor regression or progression prior to EOS. Duration of participation will be approximately 4 weeks for each patient. A patient is considered to have completed the study if all three IT-pIL12-EP treatments (Days 1, 5, \& 8) and all required pre- and post-treatment tumor biopsies have been obtained and EOS safety follow-up evaluations have been performed.

Conditions

• ER-Negative PR-Negative HER2-Negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	IT-pIL12-EP	Intratumoral pIL-12 injections followed immediately by electroporation into accessible tumor lesions

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2015-08-24
• Last updated: 2023-05-15

Locations

1 site across 1 country: United States