Study of ART0380 in Patients With Biologically Selected Solid Tumors
brief summary
This interventional study will evaluate the efficacy and safety of ART0380 as monotherapy in patients whose tumors have a biology to predict for sensitivity to inhibition of Ataxia-Telangiectasia Mutated and Rad3-related protein kinase (ATR).
detailed description
ART0380 is being developed as an oral anti-cancer agent for the treatment of patients with cancers that have defects in deoxyribonucleic acid (DNA) repair.
The study will recruit selected patients with advanced or metastatic solid tumors, specifically:
* Patients with persistent or recurrent endometrial cancer (EC) * Patients with advanced or metastatic solid tumors of any histology
Above patients will be randomized in a 1:1 ratio to one of two dose regimens of ART0380.
Safety will be evaluated on a quarterly basis, at a minimum. Patients may continue to receive ART0380 as long as they are continuing to derive benefit from treatment or until disease progression, withdrawal of consent, or until they experience unacceptable drug-related toxicity.
official title
A Phase II, Open-label, Multi-center, Basket Study of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy to Patients With Biologically Selected Advanced or Metastatic Solid Tumors (ARTIST)