Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer
NCT ID: NCT01197885
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2010-09-03
2015-08-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cadonilimab Combined With Anlotinib Followed by Radiotherapy in Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (CAR-RMEC)
NCT06681285
Sintilimab and Anlotinib Combined With Chemotherapy in Neoadjuvant Treatment of Resectable Esophageal Cancer
NCT06015035
Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma
NCT06123468
Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer
NCT04776590
Neoadjuvant Chemoradiotherapy Combined With PD-1 Antibody in Locally Advanced Esophageal Cancer
NCT04177875
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IMAB362
Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Other concurrent anticancer therapies
* Concurrent anticoagulation with vitamin K antagonists
* Therapeutic doses of Heparin (prophylactic doses accepted)
* Uncontrolled or severe illness
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ganymed Pharmaceuticals GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin Schuler, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Innere Klinik Universitätsklinikum Essen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Onkologische Schwerpunktpraxis Eppendorf
Hamburg, , Germany
Universitätsklinikum Heidelberg, NCT
Heidelberg, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Universitätsmedizin der Johannes-Gutenberg Universität
Mainz, , Germany
Klinikum rechts der Isar
München, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Piejuras Hospital
Liepāja, , Latvia
Paula Stradina Clinical University Hospital
Riga, , Latvia
Riga East Clinical Research
Riga, , Latvia
Vilnius University
Vilnius, , Lithuania
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-017365-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GM-IMAB-001-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.