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AVZO-021

DRUG2 trials

Sponsors

Avenzo Therapeutics, Inc.

Conditions

Advanced Solid TumorCCNE1 AmplificationEndometrial CancerEpithelial Ovarian CancerFallopian Tube CancerHR+, HER2-, Advanced Breast CancerHR+/HER2- Breast CancerPrimary Peritoneal Cancer

Phase 1

Study of AVZO-021 in Patients With Advanced Solid Tumors
RecruitingNCT05867251
Avenzo Therapeutics, Inc.Advanced Solid Tumor, CCNE1 Amplification, Endometrial Cancer +6
Start: 2023-08-30End: 2030-01-31Target: 430Updated: 2025-11-19
ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors
RecruitingNCT06998407
Avenzo Therapeutics, Inc.HR+, HER2-, Advanced Breast Cancer, HR+/HER2- Breast Cancer
Start: 2025-08-20End: 2030-08-01Target: 380Updated: 2026-08-10

Related Papers

A phase 1/2, first-in-human study of AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), as monotherapy and in combination for patients with advanced solid tumors, including hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) breast cancer (BC) and cyclin E1 (CCNE1)–amplified solid tumors: Updated safety and efficacy results.
Journal of Clinical Oncology2026-05-27
PS5-12-17: A phase 1/2 study of AVZO-023, a next-generation selective cyclin-dependent kinase 4 inhibitor (CDK4i), as a single agent and in combination with AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), and/or endocrine therapy in patients with advanced solid tumors
Clinical Cancer Research2026-02-17
Abstract PS4-06-08: A phase 1/2, first-in-human study of AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), as a monotherapy and in combination for patients with advanced solid tumors, including hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer and cyclin E1 (CCNE1)-amplified solid tumors: preliminary safety and efficacy results
Clinical Cancer Research2026-02-17