ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer
In brief
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).
Key facts
- Study ID
- NCT06998407
- Run by
- Avenzo Therapeutics, Inc.
- People needed
- 380
- Starts
- 2025-08-20
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Avenzo Therapeutics Recruiting Site — Los Angeles, California, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — Los Angeles, California, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — New Haven, Connecticut, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — Orlando, Florida, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — Sarasota, Florida, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — Tampa, Florida, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — Boston, Massachusetts, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — New York, New York, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — Cleveland, Ohio, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — Columbus, Ohio, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — Nashville, Tennessee, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — Fort Worth, Texas, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — Houston, Texas, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — San Antonio, Texas, United States (enrolling)
- Avenzo Therapeutics Recruiting Site — Fairfax, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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