Avenzo Therapeutics Initiates Phase 1/2 Clinical Study of AVZO-023, a Potential Best-in-Class, Novel CDK4 Selective Inhibitor

On June 5, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported initiation of a Phase 1/2 clinical study of its potential best-in-class cyclin-dependent kinase 4 (CDK4) selective inhibitor, AVZO-023, in 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 (Press release, Avenzo Therapeutics, JUN 5, 2025, View Source [SID1234653735]).

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"CDK4 is a key driver in HR+/HER2- breast cancer, and selective inhibition has emerged as a promising strategy to improve efficacy and minimize toxicity," said Antonio Giordano, M.D., Ph.D., Clinical Director, Center for Cancer Therapeutic Innovation, Dana-Farber Cancer Institute. "Preclinically, AVZO-023 demonstrates best-in-class selectivity and potency, potentially enabling rational combinations with not only endocrine therapy but also CDK2 inhibitors to address emerging resistance."

The Phase 1/2 first-in-human, open-label clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-023 as a single agent and in combination with endocrine therapy and with AVZO-021, Avenzo’s potential best-in-class CDK2 inhibitor. AVZO-021 is currently being studied in HR+/HER2- metastatic breast cancer and other advanced solid tumors.

"We are excited to have initiated our third clinical trial – and our second study in a week – ahead of our anticipated timeline," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "We look forward to investigating the potential of AVZO-023, including in combination with AVZO-021, as we believe AVZO-023 and AVZO-021 both have the potential to make a difference in the lives of patients with HR+/HER2- breast cancer."