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

NCT06998407

This study is recruiting at 16 US sites in 10 states, according to its ClinicalTrials.gov record last updated .

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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • HR+/HER2- Breast Cancer
  • HR+, HER2-, Advanced Breast Cancer

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1/2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Avenzo Therapeutics, Inc.
Last updated on ClinicalTrials.gov
August 10, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

California · 2

  • Avenzo Therapeutics Recruiting Site · Los Angeles, CA
  • Avenzo Therapeutics Recruiting Site · Los Angeles, CA

Connecticut · 1

  • Avenzo Therapeutics Recruiting Site · New Haven, CT

Florida · 3

  • Avenzo Therapeutics Recruiting Site · Orlando, FL
  • Avenzo Therapeutics Recruiting Site · Sarasota, FL
  • Avenzo Therapeutics Recruiting Site · Tampa, FL

Massachusetts · 1

  • Avenzo Therapeutics Recruiting Site · Boston, MA

New York · 1

  • Avenzo Therapeutics Recruiting Site · New York, NY

Ohio · 2

  • Avenzo Therapeutics Recruiting Site · Cleveland, OH
  • Avenzo Therapeutics Recruiting Site · Columbus, OH

Tennessee · 1

  • Avenzo Therapeutics Recruiting Site · Nashville, TN

Texas · 3

  • Avenzo Therapeutics Recruiting Site · Fort Worth, TX
  • Avenzo Therapeutics Recruiting Site · Houston, TX
  • Avenzo Therapeutics Recruiting Site · San Antonio, TX

Virginia · 1

  • Avenzo Therapeutics Recruiting Site · Fairfax, VA

Washington · 1

  • Avenzo Therapeutics Recruiting Site · Seattle, WA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.