RecruitingPhase 1Phase 2NCT05867251

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


Sponsor

Avenzo Therapeutics, Inc.

Enrollment

430 participants

Start Date

Aug 30, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests AVZO-021, a new targeted therapy, in people with advanced hormone receptor-positive/HER2-negative breast cancer, ovarian cancer, or other specific solid tumors with a particular genetic amplification (CCNE1), either alone or in combination with other drugs. **You may be eligible if...** - You are 18 or older in good general condition (ECOG 0–1) - You have advanced or metastatic HR+/HER2- breast cancer that has progressed after prior CDK4/6 inhibitor and hormonal therapy, OR - You have advanced ovarian, peritoneal, or fallopian tube cancer with a CCNE1 gene amplification that is resistant to platinum-based chemotherapy, OR - You have another solid tumor with CCNE1 amplification and no remaining effective standard treatment - Standard therapies are no longer effective or safe for you **You may NOT be eligible if...** - Effective standard treatment options are still available to you - You do not have the required genetic profile or cancer type - You have serious organ dysfunction, active brain metastases, or are pregnant or breastfeeding 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 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)

DRUGPalbociclib

Antineoplastic agent, cyclin-dependent kinase 4/6 inhibitor

DRUGFulvestrant

Antineoplastic agent, estrogen receptor antagonist

DRUGLetrozole

Antineoplastic agent, aromatase inhibitor

DRUGRibociclib

Antineoplastic CDK4/6 inhibitor

DRUGAbemaciclib

Antineoplastic CDK4/6 inhibitor

DRUGCarboplatin

Alkylating agent

DRUGSacituzumab Govitecan-hziy

Trop-2 antibody and topoisomerase inhibitor


Locations(13)

Yale Cancer Center

New Haven, Connecticut, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, United States

NYU Langone Medical Center (Tisch Hospital)

New York, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Oklahoma University

Oklahoma City, Oklahoma, United States

Providence Cancer Institute

Portland, Oregon, United States

Sidney Kimmel Cancer Center (SKCC) at Jefferson Health

Philadelphia, Pennsylvania, United States

Texas Oncology - DFW

Dallas, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

Macquarie University Hospital

Macquarie University, New South Wales, Australia

Cancer Care Wollongong

Wollongong, New South Wales, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05867251


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