Status:
ACTIVE_NOT_RECRUITING
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
Lead Sponsor:
Ambrx, Inc.
Conditions:
HER2 Positive Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd
Detailed Description
A Global, Single Arm, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
October 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04829604
Start Date
October 26 2021
End Date
June 1 2027
Last Update
November 14 2025
Active Locations (33)
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1
Research Site
Los Angeles, California, United States, 90033
2
Research Site
Newport Beach, California, United States, 92663
3
Research Site
San Francisco, California, United States, 94158
4
Research Site
Whittier, California, United States, 90602