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

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504153-12-00

Acronym

ART0380C004

Enrollment

Registered

2023-11-02

Start date

2023-12-07

Completion date

2025-05-26

Last updated

2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Metastatic Solid Tumors

Brief summary

Objective Response Rate (ORR).

Detailed description

Incidence and severity of AEs, Progression free survival (PFS), best overall response (BOR), disease control rate (DCR), duration of response (DOR) and change in tumor size (based on RECIST v1.1). Overall survival (OS, collected until the time of data cut-off)., Plasma concentration data.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR).	—

Secondary

Measure	Time frame
Incidence and severity of AEs, Progression free survival (PFS), best overall response (BOR), disease control rate (DCR), duration of response (DOR) and change in tumor size (based on RECIST v1.1). Overall survival (OS, collected until the time of data cut-off)., Plasma concentration data.	—

Countries

France, Spain

Outcome results