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

Phase 1

Waitlist Available

Led By Fred M Baik, MD

Research Sponsored by VLP Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Cohort A - Unresectable or recurrent/metastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery.

OR Cohort B and Cohort C - Patients with at least 1 measurable resectable lesion clinical stage I-IVb (cT1-4, N0-3) (AJCC, 8th Edition) (Amin, 2017), Histologically or cytologically confirmed HNSCC, measurable disease per RECIST v1.1. Scheduled to undergo tumor surgical resection of the primary tumor.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first injection to tumor resection surgery

Awards & highlights

No Placebo-Only Group

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 Squamous Cell Carcinomas 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.

Eligible Conditions

Head and Neck Cancers
Solid Tumors
Head and Neck Squamous Cell Carcinoma
Skin Cancer
Squamous Cell Carcinoma
Mouth
Oral Cancers

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first injection to 30-day follow-up visit post-final injection (cohort a) or post-surgery (cohort b and cohort c)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first injection to 30-day follow-up visit post-final injection (cohort a) or post-surgery (cohort b and cohort c)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first injection to 30-day follow-up visit post-final injection (cohort a) or post-surgery (cohort b and cohort c) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety

Secondary study objectives

Levels of circulating IL-12

Tumor response

VLPONC-01 levels in tumor tissue

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort C - Pembrolizumab onlyExperimental Treatment1 Intervention

Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 2 doses of 200mg neoadjuvant Pembrolizumab IV 3 weeks apart prior to tumor resection surgery, follow-up safety visit 30 days post-surgery.

Group II: Cohort C - Group 2 (3 x 10^8 viral particles per injection plus Pembrolizumab)Experimental Treatment2 Interventions

Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 4 doses VLPONC-01 administered IT once weekly and 2 doses of 200mg neoadjuvant Pembrolizumab IV 3 weeks apart prior to tumor resection surgery follow-up safety visit 30 days post-surgery.

Group III: Cohort C - Group 1 (1 x 10^9 viral particles per injection plus Pembrolizumab)Experimental Treatment2 Interventions

Group IV: Cohort B (1 x 10^9 viral particles per injection)Experimental Treatment1 Intervention

Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 2 doses VLPONC-01 administered IT once weekly prior to tumor resection surgery, follow-up safety visit 30 days post-surgery.

Group V: Cohort A (1 x 10^9 viral particles per injection)Experimental Treatment1 Intervention

Recurrent or Metastatic Head and Neck Cancer not scheduled for tumor resection surgery, 4 doses VLPONC-01 administered IT once weekly, with an additional follow-up safety visit 30 days post the final injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab (KEYTRUDA®)

2017

Completed Phase 1

~50

0 / 10Eligibility criteria met