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A Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART4215 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

Trial Profile

A Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART4215 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 22 Apr 2025

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At a glance

  • Drugs ART 4215 (Primary) ; Talazoparib
  • Indications Advanced breast cancer; HER2 negative breast cancer; Prostate cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Artios Pharma

Most Recent Events

  • 18 Apr 2025 Planned End Date changed from 1 Aug 2025 to 1 Aug 2026.
  • 18 Apr 2025 Planned primary completion date changed from 1 Mar 2025 to 1 Mar 2026.
  • 31 May 2024 Planned End Date changed from 1 Jan 2026 to 1 Aug 2025.

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