Malignant Ascites Clinical Trial
Official title:
A Single-Arm, Open-Label, Phase II Study to Assess the Safety and Efficacy of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intraperitoneally in Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.
A multi-center, phase II study of catumaxomab in ovarian cancer patients with recurrent
symptomatic malignant ascites requiring therapeutic paracentesis. Each eligible patient will
receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling
catheter. 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 7 months
(includes the baseline therapeutic paracentesis and screening period, 11 to 21 days treatment
period, and up to 180 days/6 months follow-up), with monthly post-study follow-up for the
lifetime of the patient.
Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 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.
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