Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06098651
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-09-28
Brief Title:
A Study of DCR-STAT3 in Adults With Solid Tumors
Sponsor:
Dicerna Pharmaceuticals Inc a Novo Nordisk company
Organization:
Novo Nordisk AS
Study Overview
Official Title:
An Open-label Phase 1 Dose-ranging Study to Evaluate the Safety Tolerability and Pharmacokinetics of Intravenous DCR-STAT3 in Adults With Refractory Solid Tumors
Status:
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:
None
Brief Summary:
This is a sequential ascending-dose multicenter study conducted in patients with refractory solid tumors designed to evaluate the safety tolerability and pharmacokinetics of DCR-STAT3
Detailed Description:
The primary goal of this first-in-human study is to assess the safety and tolerability of DCR-STAT3 in adults with refractory solid tumors Secondary study goals are to evaluate potential antitumor effects of STAT3 knockdown as assessed by circulating blood biomarkers indicative of immune activation as well as any direct impact on tumor size by appropriate imaging and RECIST 11 criteria Antitumor effects will be evaluated for DCR-STAT3 as a monotherapy
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