ASTEROID: A Phase I trial of ASTX660 in Combination with Pembrolizumab
Research type
Research Study
Full title
ASTEROID: A 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
IRAS ID
280601
Contact name
Juanita Lopez
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2020-004648-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 3 months, 16 days
Research 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.REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0753
Date of REC Opinion
19 Nov 2021
REC opinion
Further Information Favourable Opinion