Gastric Cancer Clinical Trial
Official title:
Multicenter, Open-label Phase II Study to Evaluate the Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients With Gastric Adenocarcinoma After Neoadjuvant Chemotherapy and Intended Curative Resection
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy.
An open-label, multi-center phase II study in surgically resectable patients after
neoadjuvant ECX-chemotherapy, with confirmed diagnosis of gastric adenocarcinoma and with a
high risk of disseminated tumor cells due to serosal infiltration or positive lymph nodes
after curative gastrectomy.
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively
as an intraperitoneal bolus and of four postoperative ascending doses (10-20-50-150 µg)which
will be administered as an i.p.-infusion using an installed abdominal i.p.-port on the
postoperative days 7, 10, 13 and 16.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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