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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Dec 2025

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At a glance

  • Drugs ART-6043 (Primary) ; Olaparib (Primary) ; Talazoparib (Primary)
  • Indications Advanced breast cancer; Carcinoma; HER2 negative breast cancer; Male breast cancer; Solid tumours
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Artios Pharma

Most Recent Events

  • 17 Nov 2025 According to Artios Pharma media release, proceeds from the financing will also be used to initiate a Phase 2 randomized clinical trial for Artios.
  • 17 Oct 2025 According to Artios Pharma media release, results support the potential advancement of ART6043 into Phase 2 clinical development
  • 17 Oct 2025 According to Artios Pharma media release, first data from this study were featured in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin.

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