{"entity":{"id":"avzo-021","kind":"drug","name":"AVZO-021","aka":[],"tldr":"AVZO-021 is an experimental small-molecule drug from Avenzo Therapeutics in phase 2 trials for HR-positive / HER2-negative breast cancer, ovarian cancer and endometrial cancer, aimed at HER2.","summary":"AVZO-021 is a small-molecule drug developed by Avenzo Therapeutics. Its target is HER2 (the sponsor names CDK2). The sponsor states: AVZO-021 is a highly potent and selective oral CDK2 inhibitor targeting the cyclin E-CDK2 pathway, which becomes hyperactivated as a resistance mechanism to CDK4/6 inhibitors in HR+/HER2- breast cancer and other CCNE1-amplified solid tumours. ClinicalTrials.gov describes the intervention as: AVZO-021 is an oral selective CDK2 inhibitor. It is the investigational product in 2 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, in HR-positive / HER2-negative breast cancer, ovarian cancer, endometrial cancer and triple-negative breast cancer. The largest, NCT05867251, plans to enrol 430 participants with primary completion expected 2028-01-31. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-2","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of AVZO-021","url":"https://clinicaltrials.gov/search?intr=AVZO-021"},{"label":"Sponsor pipeline page","url":"https://avenzotx.com/pipeline-and-science/"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","ovarian","endometrial","tnbc"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":["avenzo"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05867251"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"small molecule (structure undisclosed or not yet in PubChem)","mechanism":"AVZO-021 is a highly potent and selective oral CDK2 inhibitor targeting the cyclin E-CDK2 pathway, which becomes hyperactivated as a resistance mechanism to CDK4/6 inhibitors in HR+/HER2- breast cancer and other CCNE1-amplified solid tumours.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/avzo-021/","neighbours":{"cancer":[{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"ccne1","kind":"target","name":"CCNE1","route":"/targets/ccne1/"},{"id":"cdk2","kind":"target","name":"CDK2","route":"/targets/cdk2/"},{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"avenzo","kind":"company","name":"Avenzo Therapeutics","route":"/companies/avenzo/"}],"trial":[{"id":"nct06998407","kind":"trial","name":"ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors","route":"/trials/nct06998407/"},{"id":"nct05867251","kind":"trial","name":"Study of AVZO-021 in Patients With Advanced Solid Tumors","route":"/trials/nct05867251/"}]}}