ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
18 Years and older, Male and Female
ACE-Breast-03 (primary)
NCI-2021-09194
Summary
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were
previously treated with T-DXd
Objectives
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 (IV) infusion.
Eligibility
- 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 an adequate tumor sample available for confirmation of HER2 status
- Subjects must have had prior treatment with no more than 5 prior regimens of systemic
treatment 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
- 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 active ocular infections or chronic corneal disorders
- History of congestive heart failure, unstable angina pectoris, unstable atrial
fibrillation, or cardiac arrhythmia within 12 months prior to enrollment
- Grade 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0). Patients with Grade 2 neuropathy
can be enrolled at investigator's discretion
- History of unstable central nervous system (CNS) metastases
- 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
Treatment Sites in Georgia
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