Solid Tumors Clinical Trial
Official title:
A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, MTD/RP2D, and Antitumor Activity of ARTS-021 as a Single Agent and in Combination Therapy in Patients With 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).
ARTS-021 is a compound being developed for the treatment of patients with solid tumors, specifically, HR+/HER2- breast cancer and 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. ;
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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