Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Head and Neck Cancer and Solid Tumors, sponsored by VLP Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess the safety and tolerability of VLPONC-01. Safety will be based on the occurrence of any grade 3 or higher drug-related adverse events from the VLPONC-01 injections for non-surgery patients and any grade 3 or higher drug-related adverse events that result in a delay to tumor resection surgery.
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 |
What NCT06736379 shows while recruiting
NCT06736379 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06736379's enrollment target sits among peer trials
41 141st of 250 higher than 110 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer
RECRUITING · Phase 1
-
RAPA-201 Therapy of Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
RECRUITING · Phase 1
-
TheraT® Vectors (Vaccines) Combined With Chemotherapy to Treat HPV16 Head and Neck Cancers
RECRUITING · Phase 1
-
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03449238 · 41 participants · Phase 1
Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients
- NCT03900793 · 41 participants · Phase 1
Losartan + Sunitinib in Treatment of Osteosarcoma
- NCT04082520 · 41 participants · Phase 2
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
- NCT04220190 · 41 participants · Phase 2
RAPA-501 Therapy for ALS
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI