Study of ASTX295 in participants with Wild-Type TP53 Advanced Solid Tumors
Research type
Research Study
Full title
Phase 1/2 Open-Label Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX295 in Subjects with Wild-Type TP53 Advanced Solid Tumors
IRAS ID
1005784
Contact name
Lillian Chu
Contact email
Sponsor organisation
Astex Pharmaceuticals, Inc.
Eudract number
2021-005033-16
Clinicaltrials.gov Identifier
Research summary
ASTX295 is a synthetic small molecule that that acts as an antagonist (an antagonist molecule is one that works opposite to the action of its target) of human Murine Double Minute 2, or MDM2 (a protein that inhibits the activity of p53). In some types of cancer, p53 (a protein that normally plays a key role in controlling cell division and cell death) is not active due to mutations (changes) causing cancer cells to grow and spread in the body. ASTX295 reactivates p53 by blocking the action of MDM2.
The purpose of this research study is to determine the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and the initial clinical effect of ASTX295 in participants with Wild-Type TP53 Advanced Solid Tumours. There are 2 phases in this study, Phase 1 and Phase 2. Phase 1 has been conducted in the US and it was the first clinical study of ASTX295 in humans. Phase 2 will be conducted in the EU, the UK and the US.
The Phase 2 part of the study is expected to last about 2.5 years and recruit approximately 186 participants.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0245
Date of REC Opinion
12 Oct 2022
REC opinion
Further Information Favourable Opinion