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AVZO-023 is an oral, highly potent, and selective small molecule inhibitor of cyclin-dependent kinase 4 (CDK4), developed as a potential best-in-class therapy for oncology indications. It is designed to target CDK4 with sub-nanomolar potency while sparing other cyclin-dependent kinases, particularly CDK6, which is associated with hematologic toxicity. Preclinical studies have demonstrated its efficacy in in vivo xenograft models both as a single agent and in combination with the CDK2 inhibitor AVZO-021. The drug is currently being evaluated in a Phase 1/2 clinical trial for patients with advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer and select other advanced solid tumors. The trial includes monotherapy arms as well as combinations with endocrine therapy and/or AVZO-021 to address resistance mechanisms and improve therapeutic outcomes[1][2][3][5][6][7][8].
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