Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer

Trial ID or NCT#

NCT06736379

Status

recruiting iconRECRUITING

Purpose

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 Squamous Cell Carcinomas 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.

Official Title

Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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Investigator(s)

Fred M Baik, MD
Fred M Baik, MD
Head and neck surgeon, Surgical oncologist, Cutaneous oncology specialist
Assistant Professor of Otolaryngology - Head & Neck Surgery (OHNS)
Quynh-Thu Le
Quynh-Thu Le
Radiation oncologist
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Mobeen Rahman
Clinical Associate Professor, Pathology
A. Dimitrios Colevas
A. Dimitrios Colevas
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

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Contact

Clinical Research Coordinator
650-725-9333

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View on ClinicalTrials.gov