Ignite Creation Date:
2024-05-06 @ 2:32 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04349436
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2020-04-14
Brief Title:
A Phase 1B2 Study of RP1 in Solid Organ Transplant Patients With Advanced Cutaneous Malignancies
Sponsor:
Replimune Inc
Organization:
Replimune Inc
Study Overview
Official Title:
An Open-Label Multicenter Phase 1B2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ARTACUS
Brief Summary:
This Phase 1B2 study is a multicenter open-label study of RP1 to investigate the a objective response rate in addition to b safety and tolerability of RP1 for the treatment of advanced cutaneous malignancies in up to 65 evaluable organ transplant recipients This will include patients with either previous renal hepatic heart lung or other solid organ transplantation or hematopoietic cell transplant and experiencing subsequent documented locally advanced or metastatic cutaneous malignancies The study will enroll a total of 65 evaluable patients Patients will participate up to approximately 3 years including a 28-day screening period up to approximately 1 year treatment period and a 2-year follow-up period
Detailed Description:
RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response This is a Phase 1B2 open label multicenter trial evaluating the objective response rate and the safety and tolerability biodistribution shedding and preliminary efficacy of RP1 in adult hepatic renal heart lung other solid organs or hematopoietic cell transplant recipients who subsequently experienced advanced or metastatic cutaneous malignancies Patients will be dosed with RP1 by direct or ultrasound guided intra-tumoral injection into superficial subcutaneous or nodal tumors No transplanted organs will be injected
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