RecruitingPhase 1NCT06736379

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


Sponsor

VLP Therapeutics

Enrollment

41 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new type of immunotherapy — injecting a self-amplifying RNA (saRNA) particle that produces a protein called IL-12 directly into tumors — to stimulate the immune system to fight head and neck cancer. **You may be eligible if...** - You have head and neck cancer that cannot be removed surgically, or that has recurred or spread, and you have at least one tumor that can be injected - You have received prior treatment including platinum chemotherapy, 5-fluorouracil, taxane, cetuximab, or gemcitabine - You have also received prior anti-PD-1 or anti-PD-L1 immunotherapy - You have progressed after these treatments **You may NOT be eligible if...** - You have not received the required prior treatments - You have active autoimmune disease - You have serious infections or other conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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


Locations(1)

Stanford University

Stanford, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06736379


Related Trials