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 TumorsPurpose
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).
Who Can Join
To join this study, there are a few conditions. You must:
- Have breast cancer that has spread and continues to grow after up to 3 prior regimens of treatment.
- Have recovered from the serious side effects of prior therapies before taking the study treatment.
- Be able to walk and do routine activities for more than half the time you are awake.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Mark Robson’s office at 646-888-5486.