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Safety and activity of IMAB362 in combination with zoledronic acid and interleukin-2 in CLDN18.2-positive Gastric Cancer

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01671774

Astellas Study ID

The unique identification code given by the study sponsor.

GM-IMAB-001-04

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2011-005509-64

Follow Trial

Condition

Stomach or Esophageal Cancer

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Oct 2012 - Oct 2014

Masking

Not Available

Enrollment number

32

Multicenter, open-label, exploratory Phase I pilot study to investigate safety, pharmacodynamics, and pharmacokinetics of immunological effects and activity of combining multiple doses of IMAB362 with immunomodulation (zoledronic acid, interleukin-2) in patients with advanced adenocarcinoma of the stomach, the lower esophagus, or the gastroesophageal junction

Study summary

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Locations

Freiburg University Medical Center, Department of Internal Medicine II, Gastroenterology and Hepatology

Freiburg, Germany, 79106

University Hospital Tuebingen, Department of Internal Medicine I - Gastroenterology, Hepatology, Infectious Diseases

Tübingen, Germany, 72076

Piejuras Hospital, Oncology Clinic

Liepaja, Latvia, 3401

Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Department of Medical Oncology

Sofia, Bulgaria, 1606

Institut für Klinische Forschung, Krankenhaus Nordwest GmbH

Frankfurt, Germany, 60488

University Hospital Halle (Saale), Department of Internal Medicine IV

Halle, Germany, 06120

BAG / Onkologische Schwerpunktpraxis

Dresden, Germany, 01307

Riga East University Hospital, LLC, Latvian Oncology Center

Riga, Latvia, LV1038

Hospital Znojmo, Department of Radiation and Clinical Oncology

Znojmo, Czech Republic, 66902

Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, Clinic of Medical Oncology

Varna, Bulgaria, 9010

Leipzig University Hospital, University Cancer Center (UCCL)

Leipzig, Germany, 04109

University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL", Sofia, Clinic of Medical Oncology

Sofia, Bulgaria, 1527

Ulm University Hospital, Center for Internal Medicine

Ulm, Germany, 89070

Charité Universitätsmedizin Berlin - CVK, Med. Klinik m.S. Hämatologie und Onkologie

Berlin, Germany, 13353

University Hospital Motol, Department of Radiotherapy and Oncology

Prague, Czech Republic, 15006

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