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A Phase 1, Multicenter, Open-label, Multiple Dose-escalation Study of ARX788, Intravenously Administered as a Single Agent in Subjects With Advanced Breast Cancer With Multiple Levels of HER2 Expression
Zhejiang Medicine Co., Ltd.
This is a 2-part, Phase 1 first in human study with Phase 1a designed to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) in subjects with metastatic breast cancer with a human epidermal growth factor receptor 2 (HER2) test result that is in situ hybridization (ISH) positive (+) or immunohistochemistry (IHC) 3+, and Phase 1b designed to assess anticancer activity and safety in two different metastatic breast cancer cohorts namely, for tumors that test as HER2 ISH+ OR IHC3+, and a second cohort for tumors that test as HER2 ISH- AND IHC 1+ or 2+.
Recruitment on hold