NCT05798611

Study of ART0380 in Patients With Biologically Selected Solid Tumors

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Artios Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor
• Recurrent Endometrial Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	ART0380	Randomized patients will orally receive ART0380.

Timeline

• Start date: 2023-09-06
• Primary completion: 2024-11-15
• Completion: 2025-05-27
• First posted: 2023-04-04
• Last updated: 2025-11-06

Locations

15 sites across 3 countries: United States, France, Spain

Regulatory

• FDA-regulated drug study