Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014086
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-08-22
Brief Title:
Intratumoral PH-762 for Cutaneous Carcinoma
Sponsor:
Phio Pharmaceuticals Inc
Organization:
Phio Pharmaceuticals Inc
Study Overview
Official Title:
Dose Escalation Study of Neoadjuvant Intratumoral PH-762 for Cutaneous Squamous Cell Carcinoma Melanoma or Merkel Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the safety and tolerability of intratumoral injections of PH-762 in squamous cell carcinoma melanoma or Merkel cell carcinomas of the skin to understand what the body does to the PH-762 and to observe how the tumor responds to the drug Participants will receive four injections of PH-762 at weekly intervals into a single tumor followed by surgical removal of the tumor approximately two weeks later
Detailed Description:
PH-762 is a potent RNAi molecule targeting PD-1 PH-762 can inhibit the immune checkpoint PD-1 in the tumor and thereby impede tumor growth As a preoperative therapy it may decrease the lesion size and has the potential to improve surgical morbidity Intratumoral immunotherapy aims to use the tumor as a self-vaccine The local immune stimulation can induce robust priming of an anti-tumor immune response while generating systemic abscopal tumor responses mediated by properly activated anti-tumor immune cells in the circulation Local delivery of immunotherapy is expected to minimize systemic exposure and off-target toxicities
This is a non-comparative study of neoadjuvant monotherapy using PD-1 targeting self-delivering RNAi PH-762 in adult subjects with cutaneous squamous cell carcinoma melanoma or Merkel cell carcinoma The study treatment consists of four intratumoral injections of PH-762 at weekly intervals into a single tumor lesion Excision of the tumor will occur approximately two weeks following the fourth dose of IT PH-762 and the subjects will be followed for an additional 11 weeks
This is a non-comparative study of neoadjuvant monotherapy using PD-1 targeting self-delivering RNAi PH-762 in adult subjects with cutaneous squamous cell carcinoma melanoma or Merkel cell carcinoma The study treatment consists of four intratumoral injections of PH-762 at weekly intervals into a single tumor lesion Excision of the tumor will occur approximately two weeks following the fourth dose of IT PH-762 and the subjects will be followed for an additional 11 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None