US-based Avenzo Therapeutics has commenced the open-label Phase I/II trial of its cyclin-dependent kinase 4 (CDK4) selective inhibitor, AVZO-023, for breast cancer.
This therapy is intended for individuals with advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer and select other solid tumours.
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The first-in-human trial will evaluate the tolerability, preliminary clinical activity and safety of AVZO-023, both as a monotherapy and in conjunction with endocrine therapy.
It will also test AVZO-023 with AVZO-021, a CDK2 inhibitor from Avenzo’s pipeline.
AVZO-021 is currently under investigation in a Phase I trial in the US and Australia for advanced solid tumours, and in HR+/HER2- metastatic breast cancer.
Last month, the company secured clearance for its investigational new drug application (IND) for AVZO-023 from the US Food and Drug Administration (FDA).
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By GlobalDataThe company also exercised the exclusive option for the therapy from Allorion Therapeutics, securing worldwide rights for developing, manufacturing and commercialising, excluding Greater China.
Avenzo Therapeutics chief medical officer and co-founder Mohammad Hirmand said: “We are excited to have initiated our third clinical trial, and our second study in a week, ahead of our anticipated timeline.
“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.”
The clinical-stage biotechnology company develops oncology therapies including small molecules and antibody-drug conjugates (ADCs).
Adding to its portfolio, Avenzo’s AVZO-1418, an epidermal growth factor receptor (EGFR)/HER3 bispecific ADC, is under investigation in a Phase I/II trial for treating advanced solid tumours.
Last year, Avenzo announced a clinical trial collaboration and supply agreement with Gilead Sciences for evaluating a combination treatment regimen that includes AVZO-021 and Gilead’s Trodelvy for breast cancer.
