A Dose-escalation Study of ARX788, IV Administered in Subjects With Advanced Cancers With HER2 Expression
Status:
Terminated
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
This is a 2-part, Phase 1 FIH study with Phase 1a designed to determine the maximum tolerated
dose (MTD)/recommended Phase 2 dose (RP2D) in subjects with metastatic cancers with a human
epidermal growth factor receptor 2 (HER2) test result that is in situ hybridization (ISH)
positive (+) or immunohistochemistry (IHC) 3+ or 2+, and Phase 1b designed to assess
anticancer activity and safety in three expansion cohorts: two different advanced breast
cancer expansion cohorts (namely, for tumors that test as HER2 ISH positive or IHC3+ and for
tumors that test as HER2 ISH negative with IHC 2+), and one advanced gastric cancer expansion
cohort (for tumors that test as HER2 ISH positive or IHC3+).