RP2 Injection for Oral Leukoplakia

(INTERCEPT Trial)

Recruiting at 1 trial location

Overseen By Glenn Hanna, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Glenn J. Hanna

Must not be taking: Antivirals, Corticosteroids

Disqualifiers: HIV, Hepatitis B/C, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 16 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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)

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use certain antivirals like acyclovir or valacyclovir. If you are on long-term corticosteroids, the dose must not exceed prednisone 20 mg daily.

Is RP2 Injection for Oral Leukoplakia safe for humans?

The safety of similar oncolytic herpes simplex viruses has been studied in humans and animals, showing no serious adverse effects directly linked to the virus. For example, a related virus, R7020, was found to have an excellent safety profile in both animals and humans. ^{1 2 3 4 5}

How is the RP2 drug different from other treatments for oral leukoplakia?

RP2 is an enhanced oncolytic herpes simplex virus, which means it is a virus modified to specifically target and destroy cancer cells, making it unique compared to traditional treatments that do not use viruses to attack abnormal cells. ^{6 7 8 9 10}

What data supports the effectiveness of the RP2 treatment for oral leukoplakia?

Research on similar treatments, like the oncolytic herpes virus G47Δ, shows that these viruses can effectively target and destroy cancer cells in oral cancers, suggesting potential effectiveness for RP2 in treating oral leukoplakia. ^{8 10 11 12 13}

Who Is on the Research Team?

Glenn J. Hanna, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals with oral leukoplakia, a condition that can lead to mouth cancer. Participants should be at high risk of their condition progressing to cancer but have not yet developed it.

Inclusion Criteria

Willing to provide blood and tissue for diagnostic biopsies

I have a tumor that can be measured and is at least 1 cm big.

I have been diagnosed with high-risk osteoporosis.

Exclusion Criteria

Active significant herpetic infections or prior complications of HSV-1 infection

I had stage III or IV head & neck cancer before.

I have been treated with a virus-based cancer therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive RP2 injections every 2 weeks with in-clinic visits and assessments

16 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• RP2

Trial Overview The study tests the safety and potential effectiveness of RP2 injections, which is a modified herpes virus aimed at preventing oral precancerous conditions from becoming cancerous.

How Is the Trial Designed?

Group I: RP2 Injection Experimental Treatment 1 Intervention

Enrolled participants will complete the following: * A 3 subject safety run-in will be conducted with participants enrollment staggered. If \> 1 subject experiences a grade 4-5 adverse event (AE), study enrollment will pause for review by PI and study sponsor. If there are 0 grade 4-5 AEs, enrollment will proceed. * Baseline in-clinic visit with assessments, oral mucosal punch biopsy, and RP2 injection (week 1). * In-clinic visits on weeks 3, 5, 7, 8, 9, 11, 13, 15, and 16. * RP2 injections on weeks 1, 3, 5, 7, 9, 11, 13, and 15. * Repeat oral mucosal punch biopsy at week 8. * Follow up: every 3 months for up to 2 years.

Who Is Running the Clinical Trial?

Glenn J. Hanna

Lead Sponsor

Trials

6

Recruited

160+

Replimune Inc.

Industry Sponsor

Trials

16

Recruited

1,700+

Published Research Related to This Trial

G207, a modified herpes simplex virus, was safely administered to 21 patients with malignant gliomas, with doses escalating from 10^6 to 3x10^9 plaque forming units, and no serious adverse events linked to the treatment were observed.

The study provided early evidence of anti-tumor activity, as indicated by radiographic and neuropathologic findings, along with the long-term presence of viral DNA in some patients, suggesting potential therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conditionally replicating herpes simplex virus mutant, G207 for the treatment of malignant glioma: results of a phase I trial. Markert, JM., Medlock, MD., Rabkin, SD., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

A new topical treatment protocol for oral hairy leukoplakia. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Potential for efficacy of the oncolytic Herpes simplex virus 1716 in patients with oral squamous cell carcinoma. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Neoadjuvant use of oncolytic herpes virus G47Δ prevents local recurrence after insufficient resection in tongue cancer models. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Intralesional vinblastine injections for the treatment of oral Kaposi's sarcoma: report of 10 patients with 2-year follow-up. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Oncolytic herpes virus G47Δ injected into tongue cancer swiftly traffics in lymphatics and suppresses metastasis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Conditionally replicating herpes simplex virus mutant, G207 for the treatment of malignant glioma: results of a phase I trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of HER2 retargeted herpes simplex virus as therapy for high-grade glioma in immunocompetent mice. [2014]

8. England pubmed.ncbi.nlm.nih.gov

Enhancement of systemic tumor immunity for squamous cell carcinoma cells by an oncolytic herpes simplex virus. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Replication-competent, nonneuroinvasive genetically engineered herpes virus is highly effective in the treatment of therapy-resistant experimental human tumors. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Eradication of glioblastoma by immuno-virotherapy with a retargeted oncolytic HSV in a preclinical model. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Liposome-formulated interleukin-2 as an adjuvant of recombinant HSV glycoprotein gD for the treatment of recurrent genital HSV-2 in guinea-pigs. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

An attenuated adenovirus, ONYX-015, as mouthwash therapy for premalignant oral dysplasia. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Combination gene therapy for salivary gland cancer. [2019]