Study of AVZO-021 for Patients with Advanced Solid Tumors

Sponsor: Avenzo Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05867251

Provider View

This clinical trial is testing a new oral medication, AVZO-021, to see if it is safe and effective in treating advanced solid tumors. The study focuses on understanding how the drug works in the body and its potential to reduce tumors.

Patient Parameters

Program Overview

This study is the first to test AVZO-021, a new oral medication designed to treat advanced solid tumors by inhibiting a protein called CDK2, which is involved in cell growth. The trial aims to determine the safety, tolerability, and effectiveness of AVZO-021, as well as the best dose to use in future studies. The study is divided into two phases: Phase 1 will explore different doses to find the safest and most effective one, while Phase 2 will test how well the drug works in shrinking tumors.

Description

AVZO-021 is a new treatment being developed for patients with advanced solid tumors, particularly those with HR+/HER2- breast cancer and cancers with changes in a protein called cyclin E1 (CCNE1). This study is the first time AVZO-021 is being tested in humans. It is an open-label study, meaning all participants will know they are receiving the drug. The study is conducted in multiple centers and is divided into two phases.

Phase 1 is focused on finding the safest dose of AVZO-021, both when used alone and in combination with other treatments. Phase 2 will expand on this by testing the drug's ability to reduce tumors. Participants will be closely monitored for any side effects and to see how well the drug works against their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and in good general health.
  • Have a specific type of advanced solid tumor that relies on CDK2, such as HR+/HER2- breast cancer or CCNE1 altered tumors, where standard treatments are no longer effective.
  • Have measurable disease that can be tracked using standard criteria.
  • Have good bone marrow and organ function.
  • Be able to swallow pills.
  • Have not received more than two prior chemotherapy treatments for advanced cancer.

Exclusion Criteria

  • Have received another experimental drug or cancer treatment recently.
  • Have taken any CDK2, PKMYT1, or WEE1 inhibitors before.
  • Have had major surgery recently.
  • Have received recent radiation therapy for symptom relief.
  • Have active cancer spread to the brain or spinal fluid.
  • Have unresolved side effects from previous treatments.
  • Have unstable heart function.
  • Have an active infection or disease affecting the immune system.
  • Are taking certain medications that affect how the body processes drugs.
  • Have another active cancer unless it is in remission and approved by the study sponsor.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study or shortly after.

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