ARTS-021 is a compound being developed for the treatment of patients with solid tumors, specifically, cyclin E1 (CCNE1) altered malignancies. ARTS-021 is a selective and potent cyclin-dependent kinase 2 (CDK 2) inhibitor, which plays an important role in cell cycle regulation. This is a Phase 1/2 first-in-human, open-label, nonrandomized, multicenter study of ARTS-021. Phase 1 is a dose-escalation phase aimed at assessing the safety and tolerability of ARTS-021 and determining the recommended phase 2 dose (RP2D) in patients with relapsed/refractory, unresectable locally advanced, or metastatic solid tumors. Phase 2 is a dose-expansion phase that will be conducted to assess the antitumor activity of ARTS-021 in patients with relapsed/refractory, unresectable locally advanced, or metastatic solid tumors.
This study, the first clinical trial of ARTS-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of ARTS-021 in patients with advanced solid tumors. ARTS-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).