A 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
ARX788,1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle
Objective remission rate (ORR)
The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
Time frame: Until progression, assessed up to approximately 24 months
Disease control rate (DCR)
The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1.
Time frame: Baseline through end of study, assessed up to 24 months]
Duration of relief (DOR)
Time from the date of first documented response until the date of documented progression or death in the absence of disease progression
Time frame: Until progression, assessed up to approximately 24 months
Progression-free survival (PFS)
Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.
Time frame: Until progression or death, assessed up to approximately 36 months]
Overall survival (OS)
Time to death due to any cause
Time frame: Until death, assessed up to approximately 50 months
The number of subjects experiencing adverse event TEAEs
Occurrence of AEs according to CTCAE v5.0
Time frame: Up to follow-up period, approximately 50 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.