Clinical Trial

Study of AVZO-021 in Patients With Advanced Solid Tumors

Recruiting Phase 1/2
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Summary
This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2023-05-17; most recent amendment 2025-11-17.
Status change: Not Yet Recruiting → Recruiting 2023-09-28
Trial Details
NCT Number NCT05867251
Lead Sponsor Avenzo Therapeutics, Inc.
Conditions Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer, CCNE1 Amplification, Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Endometrial Cancer +1 more
Enrollment 430 participants
Start Date 2023-08-30
Primary Completion 2028-01-31 (estimated)
Study Completion 2030-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-19