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NCT06736379 · ClinicalTrials.gov registry record · Phase 1
Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
A Phase 1 study of Head and Neck Cancer and Solid Tumors, sponsored by VLP Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT06736379 is a Phase 1 study of Head and Neck Cancer and Solid Tumors that is actively recruiting participants, run by VLP Therapeutics. The registered enrollment target is 41 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06736379, a Phase 1 study of Head and Neck Cancer and Solid Tumors, is actively recruiting participants, sponsored by VLP Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Pembrolizumab (KEYTRUDA®)
- BIOLOGICAL VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection)
- BIOLOGICAL VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection)
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2025-05-13 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06736379
The ClinicalTrials.gov registry entry for NCT06736379 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (84% lower). The listed sponsor is VLP Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab (KEYTRUDA®) is the first listed.
NCT06736379 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06736379 about?
NCT06736379 is a clinical study titled "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 V...
What is the current status of trial NCT06736379?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2025-05-13. Estimated completion is 2027-12-30.
What conditions does trial NCT06736379 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Solid Tumors, Squamous Cell Carcinoma of the Head and Neck, HNSCC, Head Neck Cancer.
What interventions are being tested in trial NCT06736379?
The interventions under investigation include: Pembrolizumab (KEYTRUDA®) (DRUG), VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection) (BIOLOGICAL), VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06736379?
This trial is sponsored by VLP Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06736379 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.