Ignite Creation Date:
2024-05-06 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05082259
Status:
RECRUITING
Last Update Posted:
2023-08-22
First Post:
2021-10-06
Brief Title:
ASTEROID A Trial of ASTX660 in Combination With Pembrolizumab
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
Institute of Cancer Research United Kingdom
Study Overview
Official Title:
ASTEROIDA Phase I Trial of ASTX660 in Combination With Pembrolizumab in Patients With Solid Tumours Utilizing Triple IAP Blockade as a Strategy to Maximize Immunogenic Cell Death and the Generation of an Efficient Adaptive Immune Response
Status:
RECRUITING
Status Verified Date:
2023-08
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:
ASTEROID
Brief Summary:
This is a multi-centre Phase I dose finding and proof-of-concept study of the combination of ASTX660 together with Pembrolizumab with expansion cohorts testing preliminary efficacy in immune-refractory cancers triple negative breast cancer TNBC cervical cancer and glioblastoma
In contrast to the existing studies combining first-generation cIAP12 selective Smac mimetics with immune check point inhibitors the ASTEROID Phase I clinical trial will be the first trial utilising triple cIAP12 and XIAP blockade by ASTX660 as a strategy to maximise immunogenic cell death and the generation of an efficient adaptive immune response ASTX660 is not simply being used to repeat the data already being acquired with other first generation Smac mimetics In contrast we will investigate more in depth the mechanisms by which ASTX660 elicits its therapeutic effects both on tumour and on the host immune system This will be critical to determine the best strategy to pursue in future later stage tumour specific trials of IAP antagonists in combination with immunotherapy and to ensure appropriate molecular stratification biomarkers for the greatest benefit to patients
In contrast to the existing studies combining first-generation cIAP12 selective Smac mimetics with immune check point inhibitors the ASTEROID Phase I clinical trial will be the first trial utilising triple cIAP12 and XIAP blockade by ASTX660 as a strategy to maximise immunogenic cell death and the generation of an efficient adaptive immune response ASTX660 is not simply being used to repeat the data already being acquired with other first generation Smac mimetics In contrast we will investigate more in depth the mechanisms by which ASTX660 elicits its therapeutic effects both on tumour and on the host immune system This will be critical to determine the best strategy to pursue in future later stage tumour specific trials of IAP antagonists in combination with immunotherapy and to ensure appropriate molecular stratification biomarkers for the greatest benefit to patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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