Phase II Study of RP2 as Immunoprevention in High-Risk Oral Precancerous Disease
ConditionHigh-Risk Oral Precancerous Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlenn J. Hanna
About this trial
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)
Eligibility criteria
Qualifiers
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
Disqualifiers
Prior treatment with an oncolytic virus therapy.
Systemic infection requiring intravenous (IV) antibiotics.
Requires chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (e.g. acyclovir or valacyclovir).
Active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis). Patients with sporadic cold sores may be enrolled provided they are asymptomatic at the time of starting RP2.
Trial design
Treatments tested in this trial
- RP2 Injection
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Glenn J. Hanna
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Replimune, Inc.
Collaborator
Source ClinicalTrials.gov