Ignite Creation Date:
2024-05-06 @ 12:27 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03767348
Status:
RECRUITING
Last Update Posted:
2023-08-02
First Post:
2018-12-05
Brief Title:
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
Sponsor:
Replimune Inc
Organization:
Replimune Inc
Study Overview
Official Title:
An Open-Label Multicenter Phase 12 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
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:
IGNYTE
Brief Summary:
RPL-001-16 is a Phase 12 open label dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced andor refractory solid tumors to determine the maximum tolerated dose MTD and recommended Phase 2 dose RP2D as well as to evaluate preliminary efficacy
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 12 open label multicenter dose escalation and expansion first-in-human FIH clinical study to evaluate the safety and tolerability biodistribution shedding and preliminary efficacy of RP1 alone and in combination with nivolumab in adult subjects with advanced andor refractory solid tumors The study will include a dose escalation phase for single agent RP1 an expansion phase with a combination of RP1 and nivolumab and a Phase 2 portion in specified tumor types for the combination therapy
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