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

June 30, 2017 updated by: Ganymed Pharmaceuticals GmbH

International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Varna, Bulgaria, 9002
        • Oncology Dispensary "Dr. Marko Markov"
      • Varna, Bulgaria, 9010
        • MHAT "St.Marina"
      • Veliko Turnovo, Bulgaria, 5000
        • Complex Oncology Center
  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Bochum, Germany, 44892
        • Medizinische Univeritätsklinik Ruhr-Universität Bochum
      • Braunschweig, Germany, 38114
        • Klinikum Braunschweig
      • Essen, Germany, 45122
        • Universitätsklinikum Essen, Innere Klinik (Tumorforschung)
      • Frankfurt, Germany, 60488
        • Krankenhaus Nordwest, Klinik für Onkologie und Hämatologie
      • Halle, Germany, 06120
        • Universitätsklinikum Halle
      • Hamburg, Germany, 20249
        • Onkologische Schwerpunktpraxis Eppendorf
      • Hamburg, Germany, 20246
        • Universitäres Cancer Center Universitätsklinikum Eppendorf
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg, NCT
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
      • Mainz, Germany, 55101
        • Universitätsmedizin der Johannes-Gutenberg Universität
      • Muenchen, Germany, 81675
        • Klinikum rechts der Isar
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm
  • Latvia
      • Liepaja, Latvia
        • Piejuras Hospital
      • Riga, Latvia, 1002
        • Paula Stradina Clinical University Hospital
      • Riga, Latvia, 1038
        • Riga East Clinical Research
  • Lithuania
      • Vilnius, Lithuania, 08660
        • Vilnius University
  • Switzerland
      • St.Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMAB362
Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially.
Drug: IMAB362
Cohort 1 repeated doses of 300 mg/m2 Cohort 2 repeated doses of 600 mg/m2 Cohort 3 doses to be determined, 600mg/m2 or less

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Progression-free-survival time (PFS)
Time Frame: 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)
All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ganymed Pharmaceuticals GmbH

Investigators

  • Principal Investigator: Martin Schuler, Prof. Dr. med., Innere Klinik Universitätsklinikum Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 6, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • GM-IMAB-001-02
  • 2009-017365-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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