eligibility_summary
Adults ≥18, ECOG 0–1. Eligible: HR+/HER2− breast cancer after CDK4/6+endocrine and CCNE1-amplified gynecologic cancers or TNBC, ovarian cohorts platinum-resistant/refractory. Monotherapy: no other targetable drivers. ≤2 prior chemo. Measurable disease, adequate organs, able to swallow. Exclude: recent anticancer therapy/surgery/RT, prior CDK2/PKMYT1/WEE1, topo in B5, active CNS disease, unresolved >G1 AEs, unstable cardiac, active infection, CYP3A4 inhibitors/inducers, active 2nd cancer, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: AVZO-021 (oral small-molecule, selective CDK2 inhibitor), combinations with fulvestrant (SERD/estrogen receptor antagonist), letrozole (aromatase inhibitor), palbociclib/ribociclib/abemaciclib (oral small-molecule CDK4/6 inhibitors), sacituzumab govitecan-hziy (Trop-2–directed antibody–drug conjugate with topoisomerase inhibitor payload), and carboplatin (DNA crosslinking platinum agent). Targets/pathways: AVZO-021 inhibits CDK2–Cyclin E1 signaling to block G1/S cell-cycle progression, especially in CCNE1-amplified or CDK2-dependent tumors. Combinations target parallel cell-cycle drivers (CDK4/6), estrogen signaling (ER blockade and estrogen synthesis inhibition) in HR+/HER2- breast cancer, DNA integrity/replication (topoisomerase I and platinum-induced DNA damage), and Trop-2–expressing tumor cells. Indications include HR+/HER2- breast cancer and CCNE1-altered gynecologic cancers/TNBC.