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 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