Trial of XRD-0394, a Kinase Inhibitor, in Combination With Palliative Radiotherapy in Advanced Cancer Patients
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
XRD-0394 is a novel, potent, oral, small molecule dual inhibitor of ataxia telangiectasia
mutated kinase (ATM) and deoxyribonucleic acid (DNA)-dependent protein kinase (DNA-PK) that
has selectivity compared with other phosphatidylinositol 3-kinase-related kinase (PIKK)
family enzymes. This is a first-time-in-human study, which means that it is the first time
the study drug is being used in humans. The purpose of the study is to evaluate the safety
and tolerability of single doses of XRD-0394 administered with palliative radiotherapy (RT)
to subjects with metastatic, locally advanced, or recurrent cancer. The pharmacokinetic (PK)
profile and pharmacodynamic (PD) effects of single-dose XRD-0394 administered in combination
with palliative RT will also be characterized.