RecruitingPhase 1Phase 2NCT06998407

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


Sponsor

Avenzo Therapeutics, Inc.

Enrollment

380 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests AVZO-023 — an experimental CDK inhibitor (a drug that blocks cancer cell growth signals) — alone or with another experimental drug and/or hormone therapy in patients with advanced solid tumors, including breast cancer and other hormone-sensitive cancers. **You may be eligible if...** - You are 18 or older with a confirmed advanced solid tumor that has not responded to standard treatments - You are in reasonably good health (ECOG 0–1) - You have measurable disease or bone-only disease (in escalation phase) - Your kidney, liver, and bone marrow function are adequate **You may NOT be eligible if...** - You have previously received an experimental CDK2 or CDK4 inhibitor - You have active or untreated brain metastases - You have had recent anticancer therapy, major surgery, or radiation - You have a history of drug-induced lung inflammation (pneumonitis) - You have a known loss-of-function mutation in the Rb1 gene Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAVZO-021

AVZO-021 is an oral selective CDK2 inhibitor

DRUGFulvestrant

Antineoplastic agent, estrogen receptor antagonist

DRUGLetrozole

Antineoplastic agent, aromatase inhibitor

DRUGAVZO-023

AVZO-023 is an oral selective CDK4 inhibitor


Locations(11)

Avenzo Therapeutics Recruiting Site

Los Angeles, California, United States

Avenzo Therapeutics Recruiting Site

New Haven, Connecticut, United States

Avenzo Therapeutics Recruiting Site

Sarasota, Florida, United States

Avenzo Therapeutics Recruiting Site

Boston, Massachusetts, United States

Avenzo Therapeutics Recruiting Site

New York, New York, United States

Avenzo Therapeutics Recruiting Site

Cleveland, Ohio, United States

Avenzo Therapeutics Recruiting Site

Columbus, Ohio, United States

Avenzo Therapeutics Recruiting Site

Nashville, Tennessee, United States

Avenzo Therapeutics Recruiting Site

Houston, Texas, United States

Avenzo Therapeutics Recruiting Site

San Antonio, Texas, United States

Avenzo Therapeutics Recruiting Site

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06998407


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