Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer
VLP Therapeutics
Summary
The goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. The main questions being addressed are: The safety and tolerability of intratumoral (IT) injections of VRP-encapsulated saRNA encoding IL-12 (VLPONC-01) The tumor response to IT injections of VLPONC-01 The tumor response due to the combination of IT injections of VLPONC-01 and system IV administration of neoadjuvant pembrolizumab (anti-PD-1) treatment Researchers will compare neoadjuvant pembrolizumab alone to the combination therapy to see if the combination enhances tumor responses.
Description
The study is an Open label, Phase I study to determine the safety of IT injected VLPONC-01 as a therapeutic agent in subjects with non-resectable and resectable Head and Neck Cancer Squamous Cell Carcinomas (HCSCC), and secondarily to assess pathologic response and radiological response (assessed by RECIST 1.1 criteria) in the primary tumor and regional lymph nodes. Researchers also will explore tumor microenvironment changes in cytokine levels and cellular responses. There will be three distinct cohorts enrolling sequentially: Cohort A: Researchers will enroll unresectable or recurrent/meta…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Cohort A - Unresectable or recurrent/metastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. With one the following prior treatments: Subjects must have received a platinum containing chemotherapy regimen, 5-Fluorouracil chemotherapy, taxane based chemotherapy, cetuximab or gemcitabine for treatment of primary tumor in locally advanced, or metastatic settings. Subjects must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy. Subjects must have progressed following therapy w…
Interventions
- BiologicalVRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection)
Weekly IT injections of 1 x 10\^9 viral particles of VLPONC-01
- DrugPembrolizumab (KEYTRUDA®)
200mg twice 3 weeks apart IV
- BiologicalVRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection)
Weekly IT injections of 3 x 10\^8 viral particles of VLPONC-01
Location
- Stanford UniversityStanford, California