NCT05898399

Study of ART6043 in Advanced/Metastatic Solid Tumors Patients

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: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Artios Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.

Detailed description

ART6043 is being developed as an oral anti-cancer agent in combination with a poly (adenosine diphosphate ribose) polymerase (PARP) inhibitor (PARPi) in patients with cancers that harbor defects in DNA repair. The study will consist of two parts: 1. Part A (Dose-escalation phase): Part A will evaluate ART6043 as monotherapy (Part A1) in patients with advanced or metastatic cancer and in combination with olaparib (Part A2), in patients with advanced or metastatic cancer with genetic lesions that cause loss of function of known DNA Damage Response (DDR) genes. Olaparib is also referred as PARPi. 2. Part B (dose-expansion phase): To further confirm the safety of ART6043 in combination with olaparib (Part B1) and to assess initial effectiveness of ART6043 in combination compared to olaparib alone (Part B2) in patients with certain types of breast cancer. Patients may continue to receive ART6043 and/or olaparib as long as they may be continuing to derive clinical benefit as assessed by the investigator and/or until disease progression, withdrawal of consent or until they experience unacceptable drug-related toxicity.

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	ART6043	ART6043 will be given orally.
DRUG	Olaparib	Olaparib will be given orally.

Timeline

• Start date: 2023-06-30
• Primary completion: 2026-05-14
• Completion: 2026-12-14
• First posted: 2023-06-12
• Last updated: 2025-10-15

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study