OncRef

Clinical Trial: NCT04991480

A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Artios Pharma Ltd
Information Provided By:Artios Pharma Ltd
Last Update Posted:2026-01-27

Study Overview

Brief Summary

This clinical trial is evaluating a drug called ART4215 in participants with advanced or metastatic solid tumors. The main goals of this study are to:

  • Find the recommended dose of ART4215 that can be given safely to participants alone and in combination with talazoparib
  • Learn more about the side effects of ART4215 alone and in combination with talazoparib
  • Learn more about the effectiveness of ART4215 alone and in combination with talazoparib
  • Learn more about the effectiveness of ART4215 alone and in combination with niraparib

Official Title

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

Conditions

Advanced Cancer, Metastatic Cancer, Breast Cancer

Intervention / Treatment

  • Drug: ART4215
  • Drug: Talazoparib
  • Drug: Niraparib

Other Study ID Numbers

  • ART4215C001

Start Date (Actual)

2021-09-13

Primary Completion Date (Actual)

2025-12-24

Study Completion Date (Actual)

2025-12-24

Enrollment (Actual)

93

Study Type

Interventional

Phase

Phase 1