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New treatment option for Head and Neck Cancers- Squamous Cell
Official title Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
ClinicalTrials.gov ID: NCT06736379
What this study is testing
What is VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection)?
VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection) is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for head and neck cancers- squamous cell.
Also referred to as VLPONC-01, IL-12 saRNA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cohort A - Unresectable or recurrent/metastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. With...
- 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...
- people with either a local recurrence or a new primary tumor will be allowed.
- Age ≥ 18 years.
You likely can't join if
- Tumors which are not feasible for injections include high risk lesions that are near vital organs or important neurovascular structures, as...
- Women of childbearing potential must have a negative serum β-hCG pregnancy test within 7 days prior to the administration of the first study...
- Patients expected to receive other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal...
- 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...
See the full eligibility 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: people must have received a...
- 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.
- people 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: 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...
- Ability to understand and the willingness to provide written informed consent.
- Life expectancy \> 12 weeks (about 3 months).
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- 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.
- 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...
- 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)...
- 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...
- If applicable: Women who are breastfeeding.
- History of allogenic organ transplant that requires use of immunosuppressives.
- Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.
- Any condition that, in the investigator's opinion, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
- Uncontrolled intercurrent illness including those that do not respond to active medical intervention.
- Any contraindication to the use of known history of hypersensitivity to any immune therapy's drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.