Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623110
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Phase II Study of RP2 As Immunoprevention in High-Risk Oral Precancerous Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of Intralesional RP2 As Immunoprevention for High-Risk Oral Precancerous Disease INTERCEPT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTERCEPT
Brief 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
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 US 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
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 US 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None