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IT-pIL12-EP

Phase 1

ER-Negative PR-Negative HER2-Negative Breast Cancer | Biologics | Oncology |OncoSec Medical Incorporated|Trials Updated: May 15, 2023

IT-pIL12-EP development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

IT-pIL12-EP clinical trials

IT-pIL12-EP · 1 trial · 1 indication

Phase 1 1
NCT02531425Evaluation of Pharmacodynamic Effects of IT-pIL12-EP in Patients With TNBCER-Negative PR-Negative HER2-Negative Breast Cancer
COMPLETED10 Analytics
PHASE1COMPLETED
Evaluation of Pharmacodynamic Effects of IT-pIL12-EP in Patients With TNBC
ER-Negative PR-Negative HER2-Negative Breast Cancer
NCT0253142510
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Study Endpoints

Primary Endpoints

Changes in the proportion of intratumoral lymphocyte subsets
28 days

Paired tumor biopsy samples will be quantitatively analyzed for the number and distribution of tumor infiltrating lymphocytes (TILs).

NanoString-based gene expression
28 days

Comparison of NanoString-based gene expression profiles will be completed from paired tumor samples obtained pre- and post-treatment

Secondary Endpoints

Number of Participants with Treatment-Related Adverse Events as assessed by the CTCAE v4.0
28 days
Anti-tumor activity
28 days
Detection of plasmid IL-12 in untreated lesions
28 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IT-pIL12-EPEXPERIMENTALintratumoral injection of plasmid-IL12 following immediately by electroporation

Interventions

NameTypeDescription
IT-pIL12-EPBIOLOGICALIntratumoral pIL-12 injections followed immediately by electroporation into accessible tumor lesions
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with histologically confirmed diagnosis of locally-advanced, inoperable, metastatic and/or treatment-refractory triple negative breast cancer (TNBC). \*Treatment refractory disease is defined as the persistence of tumor lesions following at least one intervention that...

Countries:United States
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