A Dose-escalation Study of the Safety and Pharmacology of DAN 222 in Subjects with Metastatic Breast Cancer
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and PK of IV administered DAN-222 followed by a dose-escalation of DAN-222 in combination with niraparib.
Satety Objectives: To evaluate the safety and tolerability of DAN-222 administered alone and in combination with niraparib To identify DLTs and estimate the MTD or MAD of DAN-222 alone and in combination with niraparib To identify a recommended dose for further study for DAN-222 alone and in combination with niraparib Corresponding Endpoints: incidence and nature of DLTs incidence, nature, and severity of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
DAN-222 (); Niraparib ()
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