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

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).

Trial Details

NCT ID
NCT06998407
Phase
PHASE1 / PHASE2
Sponsor
Avenzo Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • AVZO-021
  • Fulvestrant
  • Letrozole
  • AVZO-023
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Sarasota, Florida, United States|27.33643,-82.53065
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Male or female aged ≥ 18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1 and life expectancy \> 3 months
  • Patients with histologically or cytologically proven advanced malignancies of preferred indications
  • Measurable disease (as assessed by investigator using RECIST v1.1) is preferred in Phase 1 dose escalation, unless otherwise specified in the proto…
  • Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Breast Cancer Trials on Trialify →