Ovarian Cancer Clinical Trial
Official title:
An Open-Label, Single-Arm, Phase II Safety and Tolerability Study of Catumaxomab (Anti-EpCAM x Anti-CD3) in Women With Advanced Epithelial Ovarian Cancer After a Complete Response to Chemotherapy
The purpose of this study is to determine whether the investigational drug catumaxomab delivered in the planned treatment schedule is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy.
A multi-center, phase II study of catumaxomab in ovarian cancer patients who experience a
complete response to chemotherapy. Each eligible patient will receive four ascending doses
of catumaxomab, administered intraperitoneally via an indwelling catheter or port.
Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval
of 3-4 days. Each patient will participate in this study for up to 4 months (includes the
baseline screening period, 11 to 21 days treatment period, and up to 90 days/3 months
follow-up), with post-study follow-up every 3 months for 2 years.
Catumaxomab is a trifunctional antibody targeting epithelial cell adhesion molecule (EpCAM)
on tumor cells and CD3 (cluster of differentiation 3) on T cells. Trifunctional antibodies
represent a new concept for targeted anticancer therapy. This new antibody class has the
capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs]
and natural killer [NK] cells) to the tumor site. According to preclinical data,
trifunctional antibodies activate these different immune effector cells, which can trigger a
complex anti-tumor immune response.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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