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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 Cancers With HER2 Expression
This is a 2-part, Phase 1, open-label study. Phase 1a is designed to determine the recommended Phase 2 dose (RP2D) in subjects with advanced cancer whose HER2 test results are in situ hybridization (ISH) positive or immunohistochemistry (IHC) 3+.
The IMP, ARX788, will be administered every 3 weeks or every 4 weeks via IV infusion. Five sequential dose escalation cohorts are planned. Cohort 1 and Cohort 2 will each enroll 3 subjects following a 3+3 design with possible expansion to 6 subjects as determined by the Safety Monitoring Committee based on dose-limiting toxicity assessment and comprehensive reviews of safety, tolerability and PK data. Cohort 3, Cohort 4 and Optional Cohort 5 will enroll 6 subjects each without planned expansion.
Phase 1b is designed to investigate the RP2D, from Phase 1a, to assess anticancer activity and safety in 2 advanced breast cancer expansion cohorts: 1) tested tumors HER2 ISH positive or IHC 3+ and 2) tested tumors HER2 ISH negative with IHC 2+.