NEW YORK – Artios Pharma said on Thursday that it has begun a Phase I/II clinical trial evaluating its ATR inhibitor, ART0380, alone and together with chemotherapy as a treatment for certain patients with solid cancers.
The trial, which is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART0380 in 180 patients, will consist of two parts. In part A, researchers will study various dosing schedules of ART0380 alone and in combination with gemcitabine in patients with advanced solid tumors. In part B1, the dose-expansion portion, patients will be eligible for ART0380 monotherapy only if their tumors test positive for loss of the ATM protein, as determined by an immunohistochemistry test.
The ATR-inhibiting agent was jointly developed by ShangPharma Innovation and the MD Anderson Cancer Center's Therapeutics Discovery Division, then licensed to Cambridge, UK-based Artios Pharma in 2019.
"Our vision is to build on the success of PARP inhibition to enable more patients to benefit from [DNA damage response] targeting medicines," Artios CEO Niall Martin said in a statement. "By using insights gained from our longstanding experience in this field, we believe that our approach will address the challenges of resistance to targeted therapy, identify patients with sensitive cancers, and optimize the therapeutic index."
In addition to ART0380, Artios has a Pol theta inhibitor in its pipeline, ART4215, which it plans to begin evaluating in the clinic as a treatment for solid tumors, such as breast and ovarian cancers, by the end of 2021.