A Phase 1/2a Study of ART6043 Given Alone and With Other Drugs in People With Breast Cancer

Full Title

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

Purpose

Researchers are assessing ART6043 and olaparib taken alone or together. The people in this study have breast cancer that has spread beyond its original location.

Mutations (changes) in your DNA can cause cancer cells to grow quickly and out of control. ART6043 blocks a protein called DNA polymerase theta, which helps repair damage to the DNA of cells. Blocking DNA polymerase theta may stop cancer cells from repairing damage to themselves and their DNA. ART6043 may cause the cancer cells to die.

In phase 1 of this study, participants took ART6043 alone or with olaparib. In the next phase of the study, participants are randomly assigned to take olaparib with or without ART6043. Both drugs are taken orally (by mouth).

Contact

For more information or to see if you can join this study, please call Dr. Mark Robson’s office at 646-888-5486.

Protocol
24-354
Phase
Phase I/II (phases 1 and 2 combined)
Disease Status
Relapsed or Refractory
Investigator
Co-Investigators
Diseases
ClinicalTrials.gov ID
NCT05898399