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

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 pembrolizu

Trial Details

NCT ID
NCT06736379
Phase
PHASE1
Sponsor
VLP Therapeutics
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection)
  • Pembrolizumab (KEYTRUDA®)
  • VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection)
Locations (sample)
  • Stanford, California, United States|37.42411,-122.16608

Key Eligibility Criteria

  • Cohort A - Unresectable or recurrent/metastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. Wi…
  • Subjects must have received a platinum containing chemotherapy regimen, 5-Fluorouracil chemotherapy, taxane based chemotherapy, cetuximab or gemcit…
  • Subjects must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy.
  • Subjects must have progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status).

For full eligibility, visit ClinicalTrials.gov.

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