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

Part of paid clinical trials in Stanford, California.

Sponsor
VLP Therapeutics
Study ID
NCT06736379
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection) — BIOLOGICAL
    Weekly IT injections of 1 x 10\^9 viral particles of VLPONC-01
  • Pembrolizumab (KEYTRUDA®) — DRUG
    200mg twice 3 weeks apart IV
  • VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection) — BIOLOGICAL
    Weekly IT injections of 3 x 10\^8 viral particles of VLPONC-01

Study Details

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.

Key Dates

Start date
May 13, 2025
Status verified
Jan 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
41 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (1 x 10^9 viral particles per injection)
    Recurrent or Metastatic Head and Neck Cancer not scheduled for tumor resection surgery, 4 doses VLPONC-01 administered IT once weekly, with an additional follow-up safety visit 30 and 90 days post the final injection.
  • Experimental: Cohort C - Group 1 (1 x 10^9 viral particles per injection plus Pembrolizumab)
    Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 4 doses VLPONC-01 administered IT once weekly and 2 doses of 200mg neoadjuvant Pembrolizumab IV 3 weeks apart prior to tumor resection surgery, follow-up safety visit 30 days post-surgery and 90 days post final treatment.
  • Experimental: Cohort C - Group 2 (3 x 10^8 viral particles per injection plus Pembrolizumab)
    Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 4 doses VLPONC-01 administered IT once weekly and 2 doses of 200mg neoadjuvant Pembrolizumab IV 3 weeks apart prior to tumor resection surgery follow-up safety visit 30 days post-surgery and 90 days post final treatment.
  • Experimental: Cohort C - Pembrolizumab only
    Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 2 doses of 200mg neoadjuvant Pembrolizumab IV 3 weeks apart prior to tumor resection surgery, follow-up safety visit 30 days post-surgery and 90 days post final treatment.

Primary Outcome Measure

Safety and tolerability [ Time Frame: First injection to 90-day follow-up visit post-final injection (Cohort A) or post-surgery (Cohort B and Cohort C) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia34305
Clinical Research Coordinator
[email protected]
650-725-9333
Fred M Baik, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Stanford University· Stanford, CA

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