Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer
- Registration Number
- NCT01197885
- Lead Sponsor
- Ganymed Pharmaceuticals GmbH
- Brief Summary
IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma. Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Metastatic, refractory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology
- CLDN18.2 expression of the biopsy material from the cancer confirmed by immunohistochemistry
- At least 1 measurable site of disease according to RECIST criteria
- Less than 3 weeks since prior chemo-or radiation therapy
- Other concurrent anticancer therapies
- Concurrent anticoagulation with vitamin K antagonists
- Therapeutic doses of Heparin (prophylactic doses accepted)
- Uncontrolled or severe illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IMAB362 IMAB362 Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially.
- Primary Outcome Measures
Name Time Method Rate of remission (CR, PR) according to RECIST Criteria All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
- Secondary Outcome Measures
Name Time Method Number of Participants with adverse events as a measure of safety and tolerability All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion Frequency and severity of adverse events according to CTCAE v3.0 All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion Progression-free-survival time (PFS) All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion The time from start of the first infusion to date of first observed disease progression or death due to progression (whichever is first)
Trial Locations
- Locations (21)
Complex Oncology Center
🇧🇬Veliko Turnovo, Bulgaria
MHAT "St.Marina"
🇧🇬Varna, Bulgaria
Universitätsklinikum Halle
🇩🇪Halle, Germany
Klinikum Braunschweig
🇩🇪Braunschweig, Germany
Oncology Dispensary "Dr. Marko Markov"
🇧🇬Varna, Bulgaria
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Medizinische Univeritätsklinik Ruhr-Universität Bochum
🇩🇪Bochum, Germany
Universitätsklinikum Essen, Innere Klinik (Tumorforschung)
🇩🇪Essen, Germany
Universitäres Cancer Center Universitätsklinikum Eppendorf
🇩🇪Hamburg, Germany
Krankenhaus Nordwest, Klinik für Onkologie und Hämatologie
🇩🇪Frankfurt, Germany
Onkologische Schwerpunktpraxis Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitätsklinikum Heidelberg, NCT
🇩🇪Heidelberg, Germany
Universitätsmedizin der Johannes-Gutenberg Universität
🇩🇪Mainz, Germany
Klinikum rechts der Isar
🇩🇪Muenchen, Germany
Riga East Clinical Research
🇱🇻Riga, Latvia
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Piejuras Hospital
🇱🇻Liepaja, Latvia
Kantonsspital St. Gallen
🇨🇭St.Gallen, Switzerland
Vilnius University
🇱🇹Vilnius, Lithuania
Paula Stradina Clinical University Hospital
🇱🇻Riga, Latvia