Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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).

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)

Details

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:

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.

Keywords

Advanced Solid Tumor, Recurrent Endometrial Cancer, Metastatic Cancer, Solid Tumors, Monotherapy, Cancer cell, Oral anti-cancer, Endometrial Neoplasms, ART0380

Eligibility

Locations

  • University of California Los Angeles (UCLA)
    Los Angeles California 90095-1781 United States
  • University of Oklahoma/Sarah Cannon Research Institute
    Oklahoma City Oklahoma 73104 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Artios Pharma Ltd
ID
NCT05798611
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 37 people participating
Last Updated