An Open-Label Phase II Study in Subjects With Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent
Inclusion Criteria:
- Recurrent ovarian cancer (including primary peritoneal cancer) following treatment
(e.g., doxorubicin HCL liposome, topotecan, etc.) for primary or secondary
platinum-refractory disease
- Immunohistochemical evidence of tumor EGFR (HER-1) expression
- At least one measurable lesion according to the WHO criteria
- Life expectancy ≥ 12 weeks
- ECOG performance status 0-1
Exclusion Criteria:
- History of prior MAb therapy
- History of prior treatment with an EGFR (HER-1) directed therapy
- Known brain metastases
- Presence of a ≥ Grade 2 pre-existing skin disorder (alopecia is permitted)
- Known intercurrent infections or immunosuppression
- Actively infected with, or chronic carriers of HBV
- Evidence of HCV disease
- Previous diagnosis of autoimmune disease
- Known hypersensitivity to the administered drugs or any of their components
- Receipt of chemotherapy, radiation therapy, or another investigational drug within 30
days of enrollment