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

NCT01197885 | Completed Phase 2 DMC

• 2 other identifiers: GM-IMAB-001-022009-017365-36
• Study Type: interventional
• Target: 54
• Locations: 5 countries
• Sites: 21

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

IMAB362

EXPERIMENTAL

Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially.

Drug: IMAB362

Interventions

IMAB362 DRUG

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

IMAB362

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ganymed Pharmaceuticals GmbH: lead

Study Sites (21)

Oncology Dispensary "Dr. Marko Markov"

Varna, 9002, Bulgaria

Location

MHAT "St.Marina"

Varna, 9010, Bulgaria

Location

Complex Oncology Center

Veliko Tarnovo, 5000, Bulgaria

Location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Medizinische Univeritätsklinik Ruhr-Universität Bochum

Bochum, 44892, Germany

Location

Klinikum Braunschweig

Braunschweig, 38114, Germany

Location

Universitätsklinikum Essen, Innere Klinik (Tumorforschung)

Essen, 45122, Germany

Location

Krankenhaus Nordwest, Klinik für Onkologie und Hämatologie

Frankfurt, 60488, Germany

Location

Universitätsklinikum Halle

Halle, 06120, Germany

Location

Universitäres Cancer Center Universitätsklinikum Eppendorf

Hamburg, 20246, Germany

Location

Onkologische Schwerpunktpraxis Eppendorf

Hamburg, 20249, Germany

Location

Universitätsklinikum Heidelberg, NCT

Heidelberg, 69120, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitätsmedizin der Johannes-Gutenberg Universität

Mainz, 55101, Germany

Location

Klinikum rechts der Isar

München, 81675, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Piejuras Hospital

Liepāja, Latvia

Location

Paula Stradina Clinical University Hospital

Riga, 1002, Latvia

Location

Riga East Clinical Research

Riga, 1038, Latvia

Location

Vilnius University

Vilnius, 08660, Lithuania

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Related Publications (1)

• Tureci O, Sahin U, Schulze-Bergkamen H, Zvirbule Z, Lordick F, Koeberle D, Thuss-Patience P, Ettrich T, Arnold D, Bassermann F, Al-Batran SE, Wiechen K, Dhaene K, Maurus D, Gold M, Huber C, Krivoshik A, Arozullah A, Park JW, Schuler M. A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study. Ann Oncol. 2019 Sep 1;30(9):1487-1495. doi: 10.1093/annonc/mdz199.

  PMID: 31240302 DERIVED

Related Links

• Link to results and other applicable study documents on the Astellas Clinical Trials website
• Link to plain language summary of the study on the Trial Results Summaries website
• Updated Vivli Worksheet

MeSH Terms

Interventions

zolbetuximab

Study Officials

• Martin Schuler, Prof. Dr. med.

  Innere Klinik Universitätsklinikum Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2010
• First Posted: September 9, 2010
• Study Start: September 3, 2010
• Primary Completion: August 13, 2015
• Study Completion: August 13, 2015
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (3); DE (13); LI (1); CH (1); LA (3)