Phase 1 Study of Safety and Tumor Response to Intratumoral VLPONC-01 and Pembrolizumab in Head and Neck Cancer

What this Trial Is About

Researchers are evaluating the safety and tolerability of a new treatment involving virus replicon particles VRP containing saRNA that encodes IL-12 in patients with head and neck squamous cell carcinoma HNSCC. This Phase I open-label study also aims to compare tumor responses when using intratumoral injections of VLPONC-01 alone versus in combination with neoadjuvant pembrolizumab, an anti-PD-1 drug. The study explores changes in tumor microenvironment, cytokine levels, and cellular responses to understand treatment effects better. Participants will be assigned to one of three cohorts based on their cancer status and treatment plan. Cohort A includes patients with unresectable or recurrentmetastatic cancer who will receive four weekly intratumoral injections of VLPONC-01. Cohort C involves patients scheduled for tumor resection surgery who will receive four weekly injections of VLPONC-01 plus two intravenous doses of pembrolizumab three weeks apart before surgery or pembrolizumab alone. Follow-up safety visits occur 30 and 90 days after the final injection or surgery. Throughout the study, participants will undergo various assessments including monitoring for safety and tolerability from the first injection through 90 days post-treatment. Researchers will measure circulating IL-12 levels, VLPONC-01 presence in tumor tissue, and tumor response via imaging and pathology. Participants must comply with scheduled visits, treatments, lab tests, and other study procedures. The total participation duration varies depending on cohort and treatment schedule, with safety follow-ups extending up to 90 days after final therapy or surgery.

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