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

NCT06998407 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2026-05-04

No results posted yet for this study

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).

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Avenzo Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2028-08-31
Completion
2030-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06998407 on ClinicalTrials.gov