Spots Global Cancer Trial Database for A Dose-escalation Study of ARX788, IV Administered in Subjects With Advanced Cancers With HER2 Expression

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Trial Identification

Brief Title: A Dose-escalation Study of ARX788, IV Administered in Subjects With Advanced Cancers With HER2 Expression

Official Title: A Phase 1, Multicenter, Open-label, Multiple Dose-escalation Study of ARX788, Intravenously Administered as a Single Agent in Subjects With Advanced Cancers With HER2 Expression

Study ID: NCT02512237

Conditions

Breast Neoplasms

Stomach Neoplasms

Interventions

ARX788

Study Description

Brief 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+).

Detailed Description: