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

NCT06736379 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

  • Head and Neck Cancers- Squamous Cell
  • Head and Neck Cancer
  • Solid Tumors
  • HNSCC
  • SCC - Squamous Cell Carcinoma
  • SCCHN
  • Head Neck Cancer
  • Head and Neck Squamous Cell Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Squamous Cell Carcinoma, Head And Neck
  • Squamous Cell Head and Neck Carcinoma
  • Oral Cavity
  • Oral Cavity Carcinoma

Interventions

BIOLOGICAL

VRP-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

DRUG

Pembrolizumab (KEYTRUDA®)

200mg twice 3 weeks apart IV

BIOLOGICAL

VRP-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

Sponsors & Collaborators

Principal Investigators

  • Fred M Baik, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2027-12-30
Completion
2027-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06736379 on ClinicalTrials.gov