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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

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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: 06 Jun 2024

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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

    • 31 May 2024 Planned End Date changed from 1 Jan 2026 to 1 Aug 2025.
    • 31 May 2024 Planned primary completion date changed from 1 Aug 2025 to 1 Mar 2025.
    • 22 Dec 2023 Planned number of patients changed from 330 to 390.

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