Viral Replicon Particles for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byFred M Baik, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: VLP Therapeutics

Stay on Your Current Meds

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with specific types of head and neck cancers, including squamous cell carcinoma and esophageal carcinoma. Participants should have a tumor suitable for injection. Details on who can join are not fully provided here.

Inclusion Criteria

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

+7 more

Exclusion Criteria

Participation in another clinical study with an investigational product during the last 30 days

If applicable: Women who are breastfeeding

Any condition that, in the investigator's opinion, would interfere with evaluation of study treatment or interpretation of patient safety or study results

+9 more

Participant Groups

The study tests the safety of injecting VRP-encapsulated saRNA encoding IL-12 into tumors, alone or combined with pembrolizumab (KEYTRUDA®), to see if it improves tumor response in head and neck cancer patients.

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 and 90 days post final treatment.

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 and 90 days post final treatment.

Group III: Cohort C - Group 1 (1 x 10^9 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 and 90 days post final treatment.

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 and 90 days post final injection.

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 and 90 days post the final injection.