ACTIVE_NOT_RECRUITING

ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)

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Conditions

HER2 Positive Metastatic Breast CancerHER2-postiveBreast cancerAntibody drugMetastaticARX788HER2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd

Official Title

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

Quick Facts

Study Start:2021-10-26
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04829604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years and older
  2. * Life expectancy ≥ 6 months
  3. * Unresectable or metastatic breast cancer subjects
  4. * Presence of at least one measurable lesion per RECIST v 1.1
  5. * Subjects must have HER2 positive breast cancer per ASCO-CAP guidelines, documented in a CLIA lab pathology report
  6. * 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.
  7. * Subjects with stable brain metastases
  8. * 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.
  9. * Adequate organ functions
  10. * Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol
  1. * History of allergic reactions to any component of ARX788.
  2. * Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease. Any requirement for supplemental oxygen.
  3. * Any active ocular infections or chronic corneal disorders
  4. * History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment
  5. * Grade 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0).
  6. * History of unstable central nervous system (CNS) metastases
  7. * Radiotherapy outside of the brain administered \< 7 days prior to first dose of ARX788
  8. * Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic diseases)
  9. * 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
  10. * 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

Contacts and Locations

Principal Investigator

Ambrx
STUDY_DIRECTOR
Ambrx, Inc.

Study Locations (Sites)

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
Athens, Georgia, 30607
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
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
Nashville, Tennessee, 37203
United States
Research Site
Dallas, Texas, 75246
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Norfolk, Virginia, 23502
United States
Research Site
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Ambrx, Inc.

  • Ambrx, STUDY_DIRECTOR, Ambrx, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-26
Study Completion Date2027-06

Study Record Updates

Study Start Date2021-10-26
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • HER2-postive
  • Breast cancer
  • Antibody drug
  • Metastatic
  • ARX788
  • HER2

Additional Relevant MeSH Terms

  • HER2 Positive Metastatic Breast Cancer