Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05858229
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-04-17
Brief Title:
Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1
Sponsor:
Sherrif Ibrahim
Organization:
Rochester Dermatologic Surgery
Study Overview
Official Title:
A Phase 1B Study of Intralesional Injection of RP1 in Patients With Resectable Cutaneous SCC
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This is a Phase 1b single-center open-label study evaluating efficacy and safety of RP1 for the treatment of resectable cutaneous Squamous Cell Carcinoma in up to 12 evaluable patients In this study patients will receive RP1 via direct intratumoral IT injection into superficial cutaneous solid tumors to assess the safety and tolerability as well efficacy of RP1 treatment The primary efficacy population is up to 12 evaluable patients with resectable CSCC The enrollment of patients with CSCC will determine study duration
Detailed Description:
None
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