Evaluation of Pharmacodynamic Effects of IT-pIL12-EP in Patients With TNBC (TNBC)
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|ClinicalTrials.gov Identifier: NCT02531425|
Recruitment Status : Active, not recruiting
First Posted : August 24, 2015
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|ER-Negative PR-Negative HER2-Negative Breast Cancer||Biological: IT-pIL12-EP||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Pharmacodynamic Effects of Intratumoral Delivery of Plasmid IL-12 Electroporation in Patients With Triple Negative Breast Cancer|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
intratumoral injection of plasmid-IL12 following immediately by electroporation
Intratumoral pIL-12 injections followed immediately by electroporation into accessible tumor lesions
Other Name: intratumoral plasmid-IL-12 + Electroporation
- Changes in the proportion of intratumoral lymphocyte subsets [ Time Frame: 28 days ]Paired tumor biopsy samples will be quantitatively analyzed for the number and distribution of tumor infiltrating lymphocytes (TILs).
- NanoString-based gene expression [ Time Frame: 28 days ]Comparison of NanoString-based gene expression profiles will be completed from paired tumor samples obtained pre- and post-treatment
- Number of Participants with Treatment-Related Adverse Events as assessed by the CTCAE v4.0 [ Time Frame: 28 days ]Patients will be evaluated throughout study participation with physical exams and standard clinical laboratory tests (e.g., hematology, serum chemistry) for the occurrence of adverse events. The incidence and severity of treatment-related adverse events will reported using descriptive statistics.
- Anti-tumor activity [ Time Frame: 28 days ]Describe evidence of anti-tumor activity
- Detection of plasmid IL-12 in untreated lesions [ Time Frame: 28 days ]Assessment of plasmid IL-12 expression for biodistribution evaluation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531425
|United States, California|
|Stanford, California, United States, 94305-5826|
|Study Director:||Sharron Gargosky, PhD||OncoSec Medical Incorporated|