OncoMatch/Clinical Trials/NCT06736379
Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
Official title: Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer
Is NCT06736379 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per and VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per for head and neck cancers- squamous cell.
Treatment: VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per · Pembrolizumab (KEYTRUDA®) · VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Tumor Agnostic
Biomarker criteria
Allowed: EGFR activating mutation
Patients with activating EGFR mutation ... must have been previously treated with an applicable tyrosine kinase inhibitor
Allowed: ALK rearrangement
Patients with ... ALK rearrangement ... must have been previously treated with an applicable tyrosine kinase inhibitor
Disease stage
Required: Stage I, II, III, IVB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — locally advanced or metastatic
Subjects must have received a platinum containing chemotherapy regimen ... for treatment of primary tumor in locally advanced, or metastatic settings.
Must have received: antimetabolite (5-Fluorouracil) — locally advanced or metastatic
Subjects must have received ... 5-Fluorouracil chemotherapy ... for treatment of primary tumor in locally advanced, or metastatic settings.
Must have received: taxane — locally advanced or metastatic
Subjects must have received ... taxane based chemotherapy ... for treatment of primary tumor in locally advanced, or metastatic settings.
Must have received: EGFR-targeted therapy (cetuximab) — locally advanced or metastatic
Subjects must have received ... cetuximab ... for treatment of primary tumor in locally advanced, or metastatic settings.
Must have received: antimetabolite (gemcitabine) — locally advanced or metastatic
Subjects must have received ... gemcitabine ... for treatment of primary tumor in locally advanced, or metastatic settings.
Must have received: anti-PD-1 therapy
Subjects must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy. Subjects must have progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status).
Must have received: anti-PD-L1 therapy
Subjects must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy. Subjects must have progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status).
Must have received: tyrosine kinase inhibitor
Patients with activating EGFR mutation or ALK rearrangement ... must have been previously treated with an applicable tyrosine kinase inhibitor.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 8.0 g/dL (transfusion/intervention allowed to achieve Hgb ≥ 8.0 g/dL)
Liver function
Total bilirubin ≤2x institutional upper limit of normal (ULN); AST(SGOT) or ALT(SGPT) ≤ 3.0x institutional ULN
Have acceptable organ and marrow function defined as follows: Absolute neutrophil count ≥ 1,500/mcL Platelets ≥ 100,000/mcL Hemoglobin ≥ 8.0 g/dL (Note: use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable) Total bilirubin ≤2x institutional upper limit of normal (ULN) AST(SGOT) or ALT(SGPT) ≤ 3.0x institutional ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford University · Stanford, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06736379 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received platinum-based chemotherapy and antimetabolite.
What disease stage is eligible?
Stage I or II or III or IVB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages