A PHASE I DOSE-ESCALATION STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multicenter, open-label, dose-escalation trial of the safety, tolerability, PK, biological and clinical activity of EMD 273066 with low-dose cyclophosphamide administered to subjects with epithelial cell adhesion molecule (EpCAM) positive advanced cancers. With some exceptions outlined in the protocol, a dose-limiting toxicity (DLT) is defined as a Grade 3 or 4 adverse drug reaction (ADR) according to National Cancer Institute Common Terminology Criteria for Adverse Events, occurring during the first cycle of administration of any dose of EMD 273066.