ASTEROID: A Trial of ASTX660 in Combination With Pembrolizumab
Status:
Not yet recruiting
Trial end date:
2026-03-16
Target enrollment:
Participant gender:
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 cIAP1/2 selective Smac
mimetics with immune check point inhibitors, the ASTEROID Phase I clinical trial will be the
first trial utilising triple cIAP1/2 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.
Phase:
Phase 1
Details
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborators:
Astex Pharmaceuticals, Inc. Cancer Research UK Merck Sharp & Dohme Corp.