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
VLP Therapeutics
41 participants
May 13, 2025
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
Plain Language Summary
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Interventions
Weekly IT injections of 1 x 10\^9 viral particles of VLPONC-01
200mg twice 3 weeks apart IV
Weekly IT injections of 3 x 10\^8 viral particles of VLPONC-01
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06736379