Clinical Trial

ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors

Study acronym: AVZO-023-1001
Recruiting Phase 1/2
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Summary
This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-023 in patients with advanced solid tumors. AVZO-023 is an oral medication that inhibits cyclin-dependent kinase 4 (CDK4).
Protocol Amendment History 1 change
notable Trial sites expanded: 11 -> 14 locations 2026-05-05
Trial Details
NCT Number NCT06998407
Lead Sponsor Avenzo Therapeutics, Inc.
Conditions HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer
Enrollment 380 participants
Start Date 2025-08-20
Primary Completion 2028-08 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-10