Actively Recruiting
Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
Led by VLP Therapeutics · Updated on 2026-01-20
41
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
V
VLP Therapeutics
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cohort A: Patients with unresectable or recurrent/metastatic head and neck cancer with at least one injectable tumor not scheduled for surgery
- Prior treatment with platinum chemotherapy, 5-Fluorouracil, taxane chemotherapy, cetuximab, or gemcitabine for primary tumor
- Prior treatment with anti-PD-1/PD-L1 therapy alone or with chemotherapy
- Must have progressed after PD-1 or PD-L1 checkpoint inhibitor therapy with progression confirmed by CT scans
- Patients with EGFR mutation or ALK rearrangement previously treated with tyrosine kinase inhibitors
- Cohort C: Patients with at least one measurable resectable lesion, clinical stage I-IVb, confirmed HNSCC, scheduled for tumor surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Primary tumors must be suitable for intratumoral injection larger than 1 cm
- Patients with local recurrence or new primary tumor allowed
- Age 18 years or older
- Adequate bone marrow and organ function, including specified blood count and liver function levels
- Ability to understand and provide written informed consent
- Life expectancy greater than 12 weeks
- Willing and able to comply with scheduled visits, treatments, and study procedures
You will not qualify if you...
- Tumors not feasible for injection due to proximity to vital organs or neurovascular structures
- Women of childbearing potential without negative pregnancy tests before first treatment
- Women and men must agree to use two effective contraception methods or abstain from sexual activity during and 6 months after treatment
- Patients expecting to receive other anti-cancer treatments before surgery with unresolved toxicity
- Participation in another investigational drug study within 30 days
- Uncontrolled illnesses not responding to treatment
- Use of immunosuppressive medication within 28 days before first injection, except certain corticosteroids
- Women who are breastfeeding
- History of allogeneic organ transplant requiring immunosuppressives
- Active or uncontrolled infections including HIV or chronic hepatitis B or C
- Any condition interfering with study treatment evaluation or patient safety
- Known hypersensitivity to any immune therapy drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 34305
Actively Recruiting
Research Team
C
Clinical Research Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here