Back to search results

Phase 2 Study of RP2 for High-Risk Oral Precancerous Disease

This study is testing an injected immune therapy called RP2 to see if it can treat high-risk oral precancerous conditions and prevent them from turning into oral cancer. RP2 is a modified herpes simplex virus (the virus that causes cold sores) designed to destroy cancer cells and activate your immune system. You may be eligible if you have high-risk oral precancerous disease, such as proliferative leukoplakia or erythroplakia, or specific genetic markers like 9p21 or CDKN2A loss. The main goal is to see the best overall response to RP2 within one year. This study is currently recruiting up to 25 participants.

Study design
This is a Phase 2, single-arm, open-label study, meaning all participants will receive RP2 and both you and the study team will know what treatment you are getting. Up to 25 people are expected to participate.
What's involved
You will have a screening visit to check eligibility, followed by in-clinic visits, blood tests, urine tests, and a mucosal punch biopsy. You will receive RP2 injections every two weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to two years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06623110

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Glenn J. Hanna
~25 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:RP2 Injection

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best Overall Response
Measured over Up to 1 year

Conditions

High-Risk Oral Precancerous Disease

Explore related trials

Oral Precancerous DiseaseCDKN2A GeneMTAP Genep21 RAS ProteinTP53 Gene

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Glenn Hanna, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Glenn Hanna, MD
[email protected]
617-632-3090
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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 evidence of head and neck cancer recurrence within the last 3 months (if applicable).
Willing to provide blood and tissue for diagnostic biopsies.
At least one target injectable measurable lesion ≥1 cm in longest diameter that can be followed.
Any smoking history is permitted. While discouraged, patients are permitted to continue tobacco use while on the study.
Age 18 years or older at the time of consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Participant must have normal marrow function and coagulation profile as defined within 21 days prior to study registration:
absolute neutrophil count ≥1,000/mcL
hemoglobin ≥9 g/dL
platelets ≥75,000/mcL, and (d) PT/INR \<2.5, and (e) aPTT \<1.5x ULN.
Women of childbearing potential (WOCBP) must agree to use appropriate method(s) of contraception. WOCBP and men should plan to use an adequate method to avoid pregnancy for 90 days after the last dose of RP2. WOCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Serum or urine BhCG testing is required within 24 hours of initial RP2 dosing.

Exclusion

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.
Known acute or chronic hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or acute or chronic hepatitis C virus (defined as HCV RNA \[qualitative\] is detected). Note: Patients who have been effectively treated are eligible for enrollment. Patients must be negative for HBsAg and HCV RNA.
Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by local health authority or clinically indicated.
A history of a prior stage III (T1-2N1, T3N0) or IV (T1-3N2, T4N0) invasive head \& neck squamous cell carcinoma treated with surgery and/or radiation with or without chemotherapy.
Patients cannot be on long-term (\>4 weeks) corticosteroids at doses exceeding prednisone 20 mg daily (or its equivalent) at the time of enrollment.
A personal history of hematopoietic stem cell (bone marrow) or solid organ transplant.
A personal history of other active malignancies, with exceptions including (but not limited to): non-melanomatous skin cancers, low-risk prostate adenocarcinoma on active surveillance, or treated cancers in remission for the last 2 years.
Significant bleeding event within the last 6 months that places the patient at risk for bleeding due to the injection procedure based on Investigator assessment.

What this trial measures

  • Best Overall ResponseUp to 1 year

    The best overall response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Responses do not require confirmation. Complete response (CR) is complete disappearance of all target lesions. Partial response (PR) is at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.