NCT04991480

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

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Artios Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is an open-label Phase I/IIa study designed to evaluate ART4215, a new first-in-class investigational medicinal product that is a potent and selective inhibitor of deoxyribonucleic acid (DNA) polymerase (pol) theta. ART4215 is being developed as an oral anti-cancer agent for monotherapy treatment of patients with cancers that harbor defects in DNA repair and in combination with anticancer medicines that cause DNA damage. This study was intended to be a Phase I/IIa trial, however the trial did not proceed to the Phase IIa portion of the study.

Conditions

• Advanced Cancer
• Metastatic Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	ART4215	Participants will receive ART4215 by mouth daily in 21-day cycles.
DRUG	Talazoparib	Talazoparib will be administered at a dose of 1 mg or 0.75 mg by mouth daily in 21-day cycles.
DRUG	Niraparib	Niraparib will be administered at a dose of 200 mg or 300 mg by mouth daily in 21-day cycles.

Timeline

• Start date: 2021-09-13
• Primary completion: 2025-12-24
• Completion: 2025-12-24
• First posted: 2021-08-05
• Last updated: 2026-01-27

Locations

8 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study