MedTrace Logo

Study of AVZO-021 in Patients With Advanced Solid Tumors

NCT05867251 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2025-11-19

No results posted yet for this study

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).

Conditions

Interventions

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

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
2023-08-30
Primary Completion
2028-01-31
Completion
2030-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05867251 on ClinicalTrials.gov