Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer

Phase 2CompletedNCT01197885

Ganymed Pharmaceuticals GmbH54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors

Interventions

IMAB362

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion 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

Locations (21)

Oncology Dispensary "Dr. Marko Markov"

Varna, Bulgaria

MHAT "St.Marina"

Varna, Bulgaria

Complex Oncology Center

Veliko Tarnovo, Bulgaria

Charité - Universitätsmedizin Berlin

Berlin, Germany

Medizinische Univeritätsklinik Ruhr-Universität Bochum

Bochum, Germany

Klinikum Braunschweig

Braunschweig, Germany

Universitätsklinikum Essen, Innere Klinik (Tumorforschung)

Essen, Germany

Krankenhaus Nordwest, Klinik für Onkologie und Hämatologie

Frankfurt, Germany

Universitätsklinikum Halle

Halle, Germany

Universitäres Cancer Center Universitätsklinikum Eppendorf

Hamburg, Germany

...and 11 more locations

Outcomes

Primary Outcomes

Rate of remission (CR, PR) according to RECIST Criteria

Time frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion

Secondary Outcomes

Number of Participants with adverse events as a measure of safety and tolerability

Time frame: 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

Time frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion

Progression-free-survival time (PFS)

The time from start of the first infusion to date of first observed disease progression or death due to progression (whichever is first)

Time frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion