NCT06623110

Phase II Study of RP2 as Immunoprevention in High-Risk Oral Precancerous Disease

A Phase 2 Study of Intralesional RP2 as Immunoprevention for High-Risk Oral Precancerous Disease (INTERCEPT)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Glenn J. Hanna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to understand the safety, tolerability, and potential efficacy of an injected immune therapy called RP2 to treat oral precancer conditions and prevent progression to an oral cancer. The name of the study drug involved in this study is: -RP2 (a genetically modified live Herpes Simplex V-1 strain)

Detailed description

This is a single-arm, open-label, single-center phase 2 study evaluating RP2 as a therapy for participants with high-risk oral precancerous diseases (OPDs). RP2 is a herpes simplex virus (a viral infection commonly known as the "cold sore virus") that has been changed to grow in and destroy cancer cells and to activate (turn on) the human immune system to attack the cancer cells. RP2 is made using herpes simplex virus type-1 (HSV-1) viral carrier which has been changed such that it is unlikely to cause human disease The U.S. Food and Drug Administration (FDA) has not approved RP2 as a treatment for high-risk oral precancerous disease. The study procedures for this research study include a screening visit to determine eligibility, in-clinic visits, blood tests, urine tests, and mucosal punch biopsy, Participants will receive the study drug every 2 weeks and will be followed for up to 2 years. It is expected that up to 25 people will take part in this research study. Replimune, Inc. is supporting this study by supplying the drug, RP2, and providing funding.

Conditions

• High-Risk Oral Precancerous Disease

Interventions

Type	Name	Description
BIOLOGICAL	RP2 Injection	Genetically modified live HSV-1 virus, 3.0 mL single-use glass vials, via intralesional (into a lesion) injection per protocol.

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2024-10-02
• Last updated: 2025-04-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study