Spots Global Cancer Trial Database for Study of ART0380 in Patients With Biologically Selected Solid Tumors

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Trial Identification

Brief Title: Study of ART0380 in Patients With Biologically Selected Solid Tumors

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)

Study ID: NCT05798611

Conditions

Advanced Solid Tumor

Recurrent Endometrial Cancer

Metastatic Cancer

Interventions

ART0380

Study Description

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.