NCT06736379

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: VLP Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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/metastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery who will receive four doses of VLPONC-01. Cohort C: Researchers will enroll HCSCC patients scheduled for tumor resection surgery who will receive four doses of VLPONC-1 and two doses of neoadjuvant pembrolizumab or only two doses of neoadjuvant pembrolizumab prior to tumor resection surgery.

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

Type	Name	Description
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

Timeline

• Start date: 2025-05-13
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2024-12-16
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study