NCT05867251

Study of AVZO-021 in Patients With Advanced Solid Tumors

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: Avenzo Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

AVZO-021 is a compound being developed for the treatment of patients with advanced solid tumors, specifically, HR+/HER2- breast cancer and cyclin E1 (CCNE1) altered malignancies. AVZO-021 is a selective and potent cyclin-dependent kinase 2 (CDK2) inhibitor, which plays an important role in cell cycle regulation. This is a Phase 1/2 first-in-human, open-label, nonrandomized, multicenter study of AVZO-021. Phase 1 is a dose-escalation phase aimed at assessing the safety and tolerability of AVZO-021 and determining the recommended phase 2 dose (RP2D) as monotherapy and combination therapy. Phase 2 is a dose-expansion phase that will be conducted to assess the antitumor activity of AVZO-021 as monotherapy and combination therapy.

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
• TNBC - Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	AVZO-021	AVZO-021 is a selective and potent oral inhibitor of CDK2 being developed for the treatment of patients with advanced solid tumors with CDK2 dependency (1A), CCNE1 amplified solid tumors (2A), HR+/HER2- BC (1B1-1B5, 2B1-2B5) and CCNE1 amplified EOC (1C, 2C)
DRUG	Palbociclib	Antineoplastic agent, cyclin-dependent kinase 4/6 inhibitor
DRUG	Fulvestrant	Antineoplastic agent, estrogen receptor antagonist
DRUG	Letrozole	Antineoplastic agent, aromatase inhibitor
DRUG	Ribociclib	Antineoplastic CDK4/6 inhibitor
DRUG	Abemaciclib	Antineoplastic CDK4/6 inhibitor
DRUG	Carboplatin	Alkylating agent
DRUG	Sacituzumab Govitecan-hziy	Trop-2 antibody and topoisomerase inhibitor

Timeline

• Start date: 2023-08-30
• Primary completion: 2028-01-31
• Completion: 2030-01-31
• First posted: 2023-05-19
• Last updated: 2025-11-19

Locations

13 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study