RECRUITING • Phase II • Stage IV • Post-Menopausal • Brain Metastases present • Interventional

The following is imported from ClinicalTrials.gov:

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

Brief Summary

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

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 (IV) infusion.

Study Design

Eligibility Criteria

Arms and Intervention

• ARX788

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