A Global Phase 2 Study of ARX788 in HER2-positiveMetastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM1 and/or T-DXd and/or Tucatinib-containing Regimens

Brief description of study

The purpose of the study is to assess anticancer activity and safety of ARX788 in subjects with metastatic HER2-positive breast cancer who were previously treated with T-DM1, and/or T-DXd, and/or tucatinib-containing regimens.The investigational medicinal product (IMP), ARX788, will be administered as an intravenous (IV) infusion. The study drug ARX788 is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s21-00351
ClinicalTrials.gov Identifier: NCT04829604
Principal Investigator: Yelena Novik.


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