DMOT4039A: Phase I data

An open-label, dose-escalation, U.S. and Dutch Phase I trial in 49 patients with unresectable pancreatic cancer or platinum-resistant ovarian cancer showed that 2.4 mg/kg IV DMOT4039A every 3 weeks led to 4 partial responses. Additionally, 1 pancreatic cancer patient without a RECIST response had a >50% reduction from baseline in CA19-9 levels and 7 ovarian cancer patients had a >50% reduction from baseline in CA-125 levels. The MTD was 2.4 mg/kg DMOT4039A. At the maximum dose level tested of 2.8 mg/kg DMOT4039A, there were 2 dose-limiting toxicities (DLTs) of grade 3 hyperglycemia and hypophosphatemia. The most common treatment-related adverse events were fatigue, nausea, diarrhea, vomiting, reduced appetite, abdominal pain and constipation. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...