ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
NCT ID: NCT04829604
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
71 participants
INTERVENTIONAL
2021-10-26
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ARX788
The investigational medicinal product (IMP), ARX788, will be administered every 3 weeks (Q3W) by intravenous (IV) infusion.
ARX788
The active pharmaceutical ingredient in ARX788 is an antibody drug conjugate (ADC) consisting of a humanized anti-HER2 monoclonal antibody (mAb) (IgG1κ) covalently conjugated to two microtubule-disrupting payloads AS269
Interventions
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ARX788
The active pharmaceutical ingredient in ARX788 is an antibody drug conjugate (ADC) consisting of a humanized anti-HER2 monoclonal antibody (mAb) (IgG1κ) covalently conjugated to two microtubule-disrupting payloads AS269
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ambrx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ambrx
Role: STUDY_DIRECTOR
Ambrx, Inc.
Locations
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Research Site
Los Angeles, California, United States
Research Site
Newport Beach, California, United States
Research Site
San Francisco, California, United States
Research Site
Whittier, California, United States
Research Site
Athens, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Louisville, Kentucky, United States
Research Site
Silver Spring, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Camden, New Jersey, United States
Research Site
New Hyde Park, New York, United States
Research Site
New York, New York, United States
Research Site
Shirley, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Portland, Oregon, United States
Research Site
Tigard, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Norfolk, Virginia, United States
Research Site
Tacoma, Washington, United States
Research Site
Frankston, Victoria, Australia
Research Site
Geelong, Victoria, Australia
Research Site
Nedlands, Western Australia, Australia
Research Site
Daegu, , South Korea
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Countries
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Other Identifiers
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ACE-Breast-03
Identifier Type: -
Identifier Source: org_study_id