# AVZO-021

Source: https://onco.cc/drugs/avzo-021/  
OnCo record `avzo-021` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-2
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- 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.

## Sources

- ClinicalTrials.gov: trials of AVZO-021: https://clinicaltrials.gov/search?intr=AVZO-021
- Sponsor pipeline page: https://avenzotx.com/pipeline-and-science/

## Connected records

- cancers: [Endometrial cancer](https://onco.cc/cancers/endometrial/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- targets: [CCNE1](https://onco.cc/targets/ccne1/), [CDK2](https://onco.cc/targets/cdk2/), [HER2](https://onco.cc/targets/her2/)
- companies: [Avenzo Therapeutics](https://onco.cc/companies/avenzo/)
- trials: [ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors](https://onco.cc/trials/nct06998407/), [Study of AVZO-021 in Patients With Advanced Solid Tumors](https://onco.cc/trials/nct05867251/)

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JSON: https://onco.cc/api/v1/entities/avzo-021.json