OncRef

Clinical Trial: NCT05898399

Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)

Status:

RECRUITING

Phase:

Phase 1

Lead Sponsor:Artios Pharma Ltd
Information Provided By:Artios Pharma Ltd
Last Update Posted:2026-10-19

Study Overview

Brief Summary

This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.

Official Title

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART6043 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

Conditions

Advanced Solid Tumor, Metastatic Solid Tumor

Intervention / Treatment

  • Drug: ART6043
  • Drug: Olaparib

Other Study ID Numbers

  • ART6043C001

Start Date (Actual)

2023-06-30

Primary Completion Date (Estimated)

2028-06-30

Study Completion Date (Estimated)

2028-09-30

Enrollment (Estimated)

181

Study Type

Interventional

Phase

Phase 1, Phase 2