Study of EC0489 for the Treatment of Refractory or Metastatic Tumors

This is a Phase 1, dose escalation study of EC0489 administered by intravenous bolus (IV)
during weeks 1 and 3 of a 4-week cycle in PART A and weekly on a 4-week cycle in PART B.

Both Parts are open to patients with refractory or metastatic cancer who have exhausted
standard therapeutic options. EC0489 is a drug that is specifically designed to enter cells
via a folate vitamin receptor. Experimental evidence shows that the target receptor is
over-expressed in many human cancers. There are no previous human studies of EC0489;
however, lab research (research in test tubes or animals) using EC0489 has shown activity
against tumors in animals. This activity in animal models suggests that EC0489 may be useful
as chemotherapy against human cancers. The primary objective of this study is to determine
the safety and maximum tolerated dose of EC0489 given by intravenous bolus. The efficacy of
treatment will also be measured.