Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer (NCT06736379) | Clinical Trial Compass
RecruitingPhase 1
Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
United States41 participantsStarted 2025-05-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Cohort A - Unresectable or recurrent/metastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. With one the following prior treatments:
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate bone marrow and organ function.
✓. Primary tumors should be amenable to intratumoral (IT) injection \>1 cm diameter. This will be determined by the Protocol Director, or the surgeon involved.
✓. Subjects with either a local recurrence or a new primary tumor will be allowed.
✓. Age ≥ 18 years.
✓. Have acceptable organ and marrow function defined as follows:
✓. Ability to understand and the willingness to provide written informed consent.
✓. Life expectancy \> 12 weeks (about 3 months).
Exclusion criteria
✕. Tumors which are not feasible for injections include high risk lesions that are near vital organs or important neurovascular structures, as determined by the Protocol Director or involved surgeon.
What they're measuring
1
Safety and tolerability
Timeframe: First injection to 90-day follow-up visit post-final injection (Cohort A) or post-surgery (Cohort B and Cohort C)
✕. Women of childbearing potential must have a negative serum β-hCG pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 48 hours prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 6 months after last dose of study drugs.
✕. Patients expected to receive other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) prior to surgery and where all acute toxicity of prior treatments have not resolved.
✕. Participation in another clinical study with an investigational product during the last 30 days.
✕. Uncontrolled intercurrent illness including, that do not respond to active medical intervention.
✕. Current or prior use of immunosuppressive medication within 28 days before the first dose of injection, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid.
✕. If applicable: Women who are breastfeeding.
✕. History of allogenic organ transplant that requires use of immunosuppressives.