RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer

Quick Facts

Study Start:2025-05-13

Study Completion:2027-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06736379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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: 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate bone marrow and organ function. 3. Primary tumors should be amenable to intratumoral (IT) injection \>1 cm diameter. This will be determined by the Protocol Director, or the surgeon involved. 4. Subjects with either a local recurrence or a new primary tumor will be allowed. 5. Age ≥ 18 years. 6. Have acceptable organ and marrow function defined as follows: 7. Ability to understand and the willingness to provide written informed consent. 8. Life expectancy \> 12 weeks (about 3 months). 9. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.	1. 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. 2. 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. 3. 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. 4. Participation in another clinical study with an investigational product during the last 30 days. 5. Uncontrolled intercurrent illness including, that do not respond to active medical intervention. 6. 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. 7. If applicable: Women who are breastfeeding. 8. History of allogenic organ transplant that requires use of immunosuppressives. 9. Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C. 10. Any condition that, in the investigator's opinion, would interfere with evaluation of study treatment or interpretation of patient safety or study results. 11. Uncontrolled intercurrent illness including those that do not respond to active medical intervention. 12. Any contraindication to the use of known history of hypersensitivity to any immune therapy's drugs.

Inclusion Criteria

Exclusion Criteria

1. 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:
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate bone marrow and organ function.
3. Primary tumors should be amenable to intratumoral (IT) injection \>1 cm diameter. This will be determined by the Protocol Director, or the surgeon involved.
4. Subjects with either a local recurrence or a new primary tumor will be allowed.
5. Age ≥ 18 years.
6. Have acceptable organ and marrow function defined as follows:
7. Ability to understand and the willingness to provide written informed consent.
8. Life expectancy \> 12 weeks (about 3 months).
9. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

1. 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.
2. 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.
3. 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.
4. Participation in another clinical study with an investigational product during the last 30 days.
5. Uncontrolled intercurrent illness including, that do not respond to active medical intervention.
6. 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.
7. If applicable: Women who are breastfeeding.
8. History of allogenic organ transplant that requires use of immunosuppressives.
9. Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.
10. Any condition that, in the investigator's opinion, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
11. Uncontrolled intercurrent illness including those that do not respond to active medical intervention.
12. Any contraindication to the use of known history of hypersensitivity to any immune therapy's drugs.

Contacts and Locations

Study Contact

Clinical Research Coordinator

CONTACT

650-725-9333

tpark22@stanford.edu

Principal Investigator

Fred M Baik, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University

Stanford, California, 34305

United States

Collaborators and Investigators

Sponsor: VLP Therapeutics

Fred M Baik, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-13

Study Completion Date2027-12-30

Study Record Updates