ARX788 in HER2-positive Metastatic Breast Cancer Patients
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital
About this trial
A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.
Eligibility criteria
Qualifiers
18 to 75 years old (including upper and lower limits), male or female;
Unresectable locally advanced, recurrent or metastatic BC;
Has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic BC;
Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
Disqualifiers
Has known history to be allergic to any active ingredient or excipient of ARX788;
With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy;
Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment;
Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
Trial design
Treatments tested in this trial
- ARX788
Treatment groups
44 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov