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New drug AVZO-1418 enters human trials for Hard-to-Treat cancers

NCT ID NCT07038343

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests a new drug called AVZO-1418 in people with advanced solid tumors that have spread. The goal is to find a safe dose and see if it shrinks tumors. About 480 adults will take part, receiving the drug alone or with other treatments.

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 480 people

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

Started

Jun 2025

Expected to finish

Dec 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 to 75 years

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 * Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \> 3 months. * Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications: o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol). * Measurable disease as assessed by Investigator using RECIST v1.1. * Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable. * Other protocol-defined Inclusion criteria apply. Key Exclusion Criteria * Uncontrolled hypertension. * Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated. * History of drug-induced interstitial lung disease (ILD). * History of any serious cardiovascular condition. * Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose. * History of a solid organ transplant. * Other protocol-defined Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms cancer carcinoma epithelial neoplasm lung cancer lung neoplasm malignant tumor of nasopharynx metastatic malignant neoplasm nasopharyngeal carcinoma nasopharyngeal neoplasm Neoplasm Metastasis small cell lung carcinoma urothelial carcinoma

As listed by the trial registrant

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

Biliary tract cancer (BTC) Epithelial tumor Locally advanced Lung cancers Metastatic solid tumors Nasopharyngeal cancers Solid tumor cancer Urothelial 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

    19 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

    Gilbert, Arizona, 85234, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Los Angeles, California, 90048, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Los Angeles, California, 90095, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Denver, Colorado, 80218, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Washington D.C., District of Columbia, 20007, 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

    Atlanta, Georgia, 30322, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    New York, New York, 10029, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Dallas, Texas, 75039, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Houston, Texas, 77054, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    West Valley City, Utah, 84119, 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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Other studies related to the condition(s) this trial covers.