Investigational Drug
AVZO-021
TrialFetch AI Analysis
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Overview
AVZO-021 (formerly ARTS-021) is an investigational, once-daily oral cancer drug being studied in a phase 1/2 trial for advanced solid tumors, including hormone receptor-positive, HER2-negative (HR+/HER2−) breast cancer and tumors with CCNE1 amplification. Early human results are available, but they come from a small, nonrandomized study and do not establish clinical benefit. (ascopubs.org)
Mechanism of action
AVZO-021 selectively inhibits cyclin-dependent kinase 2 (CDK2), an enzyme involved in cell-cycle progression. The rationale for testing it includes the role of elevated cyclin E–CDK2 activity in some CCNE1-amplified tumors and in resistance to CDK4/6 inhibitors in breast cancer. (ascopubs.org)
Efficacy
In the latest reported efficacy analysis (May 7, 2026), 3 of 26 evaluable patients receiving AVZO-021 alone had confirmed responses; a fourth response awaited confirmation. Two of 13 evaluable patients receiving AVZO-021 with fulvestrant had confirmed responses. Across all monotherapy doses, median progression-free survival among 33 patients with HR+/HER2− breast cancer was 5.3 months. These are preliminary findings, not comparisons against another treatment. (avenzotx.com)
Safety
Among 64 patients in the reported safety analysis, the most common treatment-emergent adverse events were nausea (52%), fatigue (48%), anemia (39%), and vomiting (34%). Most events were grade 1 or 2. The conference poster also reported 14 dose reductions and two treatment discontinuations due to adverse events, plus dose-limiting grade 3 syncope and grade 4 thrombocytopenia in one patient each. (avenzotx.com)
Further reading
Last updated: Sep 2026
Active trials using AVZO-021
Found 2 active trials using this drug:
TrialFetch AI summary: Eligible adults have ECOG performance status 0–1 and either advanced solid tumors with CDK4 or CCND1 amplification or locally advanced/metastatic HR-positive, HER2-negative breast cancer; prior selective CDK inhibitor treatment is excluded. They receive the oral selective CDK4 inhibitor AVZO-023 alone or with the investigational CDK2 inhibitor AVZO-021 and/or endocrine therapy (letrozole or fulvestrant).
ClinicalTrials.gov ID: NCT06998407
TrialFetch AI summary: Adults with ECOG 0–1 and measurable advanced HR+/HER2− breast cancer or selected CCNE1-amplified solid tumors receive oral AVZO-021, an investigational CDK2 inhibitor, alone or in cohort-specific combinations. Combinations include endocrine therapy, CDK4/6 inhibitors, sacituzumab govitecan, or carboplatin; eligibility and prior-treatment requirements vary by cohort.
ClinicalTrials.gov ID: NCT05867251
