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New smart drug takes aim at Hard-to-Treat cancers

NCT ID NCT07193511

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 26, 2026 · Updated 7 times

Summary

This study tests a new drug called AVZO-103 in people with advanced bladder cancer or other solid tumors that have spread. The drug is designed to seek out and attack cancer cells while sparing healthy ones. The trial will enroll about 355 adults and is the first time this drug is being tested in humans, focusing on safety and whether 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-103 (a drug that targets two proteins on cancer cells, Nectin4 and Trop2, to deliver a toxin directly to the tumor)
What this could lead to
If successful, this could provide a new treatment option for people with advanced bladder cancer or other solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early first-in-human study, so the drug may not be safe or effective. Side effects could be serious, and the benefits seen in a small group may not hold up in larger trials.

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 355 people

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

Started

Oct 2025

Expected to finish

Sep 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: * Patient must be an adult, 18 years of age and older 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 urothelial cancer and other 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: * 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. * Prior Stevens-Johnson syndrome/toxic epidermal necrolysis. * 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 allogenic stem cell or solid organ transplant. * Other protocol-defined Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

cancer metastatic malignant neoplasm Neoplasm Metastasis urothelial carcinoma

As listed by the trial registrant

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

Locally advanced Metastatic solid tumors 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

    14 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

    San Francisco, California, 94158, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Aurora, Colorado, 80045, 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

    Tampa, Florida, 33612, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    New York, New York, 10065, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Austin, Texas, 78758, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Avenzo Therapeutics Recruiting Site

    RECRUITING

    Irving, Texas, 75039, United States

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