NCT06998407

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

A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine Therapy in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Avenzo Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

AVZO-023 is an oral, potent, and selective inhibitor of CDK4. AVZO-021 is an oral, potent, and selective inhibitor of CDK2 that is currently being investigated in a global Phase 1/2 study in patients with advanced hormone receptive positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (NCT05867251). In Phase 1, the safety and tolerability of AVZO-023 in patients with HR+/HER2- locally advanced or metastatic breast cancer (mBC) will be assessed. The goal of Phase 1 is to determine the MTD/preliminary RP2D of AVZO-023 for use as monotherapy and in combination with AVZO-021 with or without endocrine therapy (ET). Phase 2 will assess the antitumor activity and confirm the RP2D of AVZO-023 in combination therapy in patients with HR+/HER2- locally advanced or mBC.

Conditions

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

Interventions

Type	Name	Description
DRUG	AVZO-021	AVZO-021 is an oral selective CDK2 inhibitor
DRUG	Fulvestrant	Antineoplastic agent, estrogen receptor antagonist
DRUG	Letrozole	Antineoplastic agent, aromatase inhibitor
DRUG	AVZO-023	AVZO-023 is an oral selective CDK4 inhibitor

Timeline

• Start date: 2025-08-20
• Primary completion: 2028-08-01
• Completion: 2030-08-01
• First posted: 2025-05-31
• Last updated: 2026-04-03

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study