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New pill AVZO-023 takes on advanced breast cancer in first human trial

NCT ID NCT06998407

Disease control Sponsor: Avenzo Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 5 times

Summary

This study tests a new oral drug called AVZO-023, which blocks a protein (CDK4) that helps cancer cells grow. It is being tested alone or with other drugs in 380 adults with advanced solid tumors, especially a type of breast cancer called HR+/HER2-. The goal is to find a safe dose and see if it can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AVZO-023 (a CDK4 inhibitor drug taken by mouth)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced breast cancer or other solid tumors that have stopped responding to current therapies.
What could go wrong
This is an early first-in-human study, so safety and effectiveness are not yet known. The drug may cause side effects or fail to shrink tumors, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Male or female aged ≥ 18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1 and life expectancy \> 3 months * Patients with histologically or cytologically proven advanced malignancies of preferred indications * Measurable disease (as assessed by investigator using RECIST v1.1) is preferred in Phase 1 dose escalation, unless otherwise specified in the protocol, and in all patients in Phase 2. Bone only disease is allowed in dose escalation. * Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable * Adequate renal, liver, and bone marrow function Key Exclusion Criteria: * Patients should not have received any prior selective investigational CDK (CDK2, CDK4, CDK2/4, CDK2/4/6) inhibitors * Has known active brain metastasis (have either previously untreated intracranial CNS metastasis or previously treated intracranial central nervous system (CNS) metastasis with radiologically documented new or progressing CNS lesions) or leptomeningeal disease * Other concurrent invasive malignancy or a prior invasive malignancy for which treatment was completed within 3 years before the first dose on study except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or colorectal adenomatous polyps * Last anticancer treatment within 2 weeks (4 weeks for biologic, immunotherapy or ADC) or 5 half-lives of the drug, whichever is shorter, prior to first dose on study * Major surgery within 4 weeks prior to first dose on study * Have received radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment, except for patients receiving whole brain radiotherapy, which must be completed at least 4 weeks prior to the first dose of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have active radiation pneumonitis. Patients who received radiation of \>25% of bone marrow are excluded. * Strong or moderate CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose on study * History of serious cardiovascular conditions within 6 months prior to first dose on study * Unresolved toxicities from prior therapy greater than Grade 1 (per CTCAE version 5.0) (with exceptions of alopecia, vitiligo, and ≤ Grade 2 peripheral neuropathy) prior to the first dose on study * History of drug-induced pneumonitis/interstitial lung disease * Confirmed loss of function mutation or deletion of Rb1 gene * Previous high-dose chemotherapy requiring stem cell rescue

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor CCND1 gene amplification CDK gene mutation CDK4 gene amplification HR+ / HER2- advanced breast cancer HR+/HER2- breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Los Angeles, California, 90025, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Los Angeles, California, 90095, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    New Haven, Connecticut, 06519, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Orlando, Florida, 32827, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Tampa, Florida, 33612, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    New York, New York, 10016, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Columbus, Ohio, 43221, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Seattle, Washington, 98109, United States

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