Study of VLPONC-01 with or without Pembrolizumab for Head and Neck Cancer
This study is testing a new treatment called VLPONC-01, which is a virus-like particle carrying genetic material (saRNA) that makes a protein called IL-12. Researchers will inject VLPONC-01 directly into tumors in patients with head and neck cancers. The main goals are to see how safe VLPONC-01 is and how well it is tolerated. The study also wants to see if VLPONC-01 can shrink tumors, both on its own and when combined with Pembrolizumab (KEYTRUDA®), a common immunotherapy drug. You might be able to join if you have head and neck cancer that has returned, spread, or cannot be removed by surgery, and have received certain prior treatments. The study is currently unclear on its recruitment status and plans to enroll 41 participants.
- Study design
- This is an open-label, Phase I study with three groups of participants, enrolling one after the other. It will involve 41 participants.
- What's involved
- Participants in Cohort A will receive four weekly injections of VLPONC-01. Participants in Cohort C will receive four weekly injections of VLPONC-01 and two doses of Pembrolizumab, or two doses of Pembrolizumab alone, before surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and tolerability will be monitored from the first injection up to 90 days after your last injection or after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
At a glance
Conditions
NCT06736379
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Stanford University
Stanford, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Fred M Baik, MD · PRINCIPAL_INVESTIGATOR · Stanford University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety and tolerabilityFirst injection to 90-day follow-up visit post-final injection (Cohort A) or post-surgery (Cohort B and Cohort C)
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.