ORION-1: A phase 1/2, first-in-human study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of AVZO-023 as a single agent, and in combination with AVZO-021 and/or endocrine therapy in patients with advanced solid tumors
Sponsor: Avenzo Therapeutics Inc.
Phase: 1, 2
Disease: Hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer
EU trial number: 2026-525948-15-00
Population: Approximately 380 adults with HR-positive, HER2-negative unresectable locally advanced or metastatic breast cancer, ECOG 0–1. Phase 1 dose-escalation evaluates AVZO-023 monotherapy (with fulvestrant in indicated cohorts) and combinations with selective CDK2 inhibitor AVZO-021 and letrozole or fulvestrant, followed by Phase 2 expansion of four endocrine combinations in first-line or post-CDK4/6-inhibitor populations.
Register Investigator Interest
Interested in offering this trial to suitable patients?