A Phase 2 Study of Intralesional RP2 as Immunoprevention for High-Risk Oral Precancerous Disease (INTERCEPT)
Glenn J. Hanna
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)
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 treatm…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with a diagnosis of high-risk OPD defined by any of the following: * Proliferative leukoplakia (PL) * Localized leukoplakia showing at least moderate dysplasia not treated with surgery * Erythroplakia (regardless of dysplasia) * High-risk LOH profile: 9p21 or CDKN2A or MTAP loss; regardless of personal oral cancer history * Any degree of dysplasia with a known TP53 mutation * A history of treated stage 1 or 2 (AJCC 2017 8th edition) HNSCC with at least moderate dysplasia at the resection margins or known 9p21 loss or a known TP53 mutation * No evide…
Interventions
- BiologicalRP2 Injection
Genetically modified live HSV-1 virus, 3.0 mL single-use glass vials, via intralesional (into a lesion) injection per protocol.
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts