Ignite Creation Date:
2024-05-06 @ 12:51 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03861793
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2019-02-25
Brief Title:
A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 Nemvaleukin Alfa as a Single Agent and in Combination With Anti-PD-1 Antibody Pembrolizumab in Subjects With Select Advanced or Metastatic Solid Tumors ARTISTRY-2
Sponsor:
Mural Oncology Inc
Organization:
Mural Oncology Inc
Study Overview
Official Title:
A Phase 12 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 001
Status:
COMPLETED
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 study will characterize the safety and tolerability and identify the recommended Phase 2 dose RP2D of subcutaneous SC ALKS 4230 as monotherapy and in combination with pembrolizumab
Detailed Description:
This study will evaluate ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors
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