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New hope for advanced breast cancer: experimental drug targets tumors after other treatments fail

NCT ID NCT04829604

Disease control Sponsor: Ambrx, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests an experimental drug called ARX788 in people with HER2-positive breast cancer that has spread and no longer responds to standard treatments. About 72 adults will receive the drug to see if it shrinks tumors and how long that effect lasts. The goal is to find a new option for controlling the disease when other therapies stop working.

Why investors are watching

Johnson & Johnson, through its Ambrx, Inc. unit, is running a phase 2 trial of the drug ARX788 in 72 patients with HER2-positive metastatic breast cancer who have already been treated with T-DXd. For a very small company, this readout matters because it tests whether ARX788 can control the disease in patients who have run out of a standard treatment option. A clear result could define the drug's future and the company's value.

If it works: If ARX788 shows meaningful disease control in these patients, Johnson & Johnson could have a new treatment option for a group with few choices. That positive data might support further development and eventual regulatory discussions.

If it fails: A failure or delay in this trial would be a setback, since the company has few other late-stage programs. Trials in this setting often fail, and a negative result could leave the drug without a clear path forward.

AI-written from the trial record. Speculative, and not investment advice.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

72 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Jun 2027

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: * Age ≥ 18 years and older * Life expectancy ≥ 6 months * Unresectable or metastatic breast cancer subjects * Presence of at least one measurable lesion per RECIST v 1.1 * Subjects must have HER2 positive breast cancer per ASCO-CAP guidelines, documented in a CLIA lab pathology report * Subjects must have had prior treatment with no more than 5 prior regimens of systemic treatment HER-2 targeting therapy or chemotherapy in the metastatic setting. One of these prior treatments must have been treatment with T-DXd. * Subjects with stable brain metastases * Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1 as per the NCI-CTCAE v 5.0, except alopecia, vitiligo, Grade 2 peripheral neuropathy, or endocrine toxicities that are stable on hormone replacement. * Adequate organ functions * Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol Key Exclusion Criteria: Any subject who meets any of the following criteria is excluded from the study: * History of allergic reactions to any component of ARX788. * Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease. Any requirement for supplemental oxygen. * Any active ocular infections or chronic corneal disorders * History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment * Grade 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0). * History of unstable central nervous system (CNS) metastases * Radiotherapy outside of the brain administered \< 7 days prior to first dose of ARX788 * Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic diseases) * Any uncontrollable intercurrent illness, infection (including subjects with active, symptomatic Covid-19 infections), or other conditions that could limit study compliance or interfere with assessments * Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788

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Conditions

The condition(s) this trial relates to.

breast neoplasm HER2 positive breast carcinoma Neoplasm Metastasis

As listed by the trial registrant

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

HER2-positive metastatic breast cancer

Contacts and locations

Locations

  • Research Site

    Los Angeles, California, 90033, United States

  • Research Site

    Newport Beach, California, 92663, United States

  • Research Site

    San Francisco, California, 94158, United States

  • Research Site

    Whittier, California, 90602, United States

  • Research Site

    Atlanta, Georgia, 30322, United States

  • Research Site

    Chicago, Illinois, 60611, United States

  • Research Site

    Louisville, Kentucky, 40207, United States

  • Research Site

    Silver Spring, Maryland, 20904, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    St Louis, Missouri, 63110, United States

  • Research Site

    Omaha, Nebraska, 68130, United States

  • Research Site

    Las Vegas, Nevada, 89128, United States

  • Research Site

    Camden, New Jersey, 08103, United States

  • Research Site

    New Hyde Park, New York, 11042, United States

  • Research Site

    New York, New York, 10028, United States

  • Research Site

    Shirley, New York, 11967, United States

  • Research Site

    The Bronx, New York, 10469, United States

  • Research Site

    Portland, Oregon, 97213, United States

  • Research Site

    Tigard, Oregon, 97223, United States

  • Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    Dallas, Texas, 75246, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    San Antonio, Texas, 78229, United States

  • Research Site

    Norfolk, Virginia, 23502, United States

  • Research Site

    Tacoma, Washington, 98405, United States

  • Research Site

    Frankston, Victoria, 3199, Australia

  • Research Site

    Geelong, Victoria, 3220, Australia

  • Research Site

    Nedlands, Western Australia, 6009, Australia

  • Research Site

    Daegu, 42601, South Korea

  • Research Site

    Seongnam-si, 13620, South Korea

  • Research Site

    Seoul, 02841, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

More trials for these conditions

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