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Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00909025
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : July 2, 2017
Information provided by (Responsible Party):
Astellas Pharma Inc ( Ganymed Pharmaceuticals GmbH )

Brief Summary:
Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase I study is to establish safety, toxicity and maximal tolerable dose of a single infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and gastric adenocarcinoma

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: Claudiximab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical First-in-human Single-dose Escalation Study Evaluating the Safety and Tolerability of Claudiximab (iMAB-362) in Hospitalized Patients With Advanced Gastroesophageal Cancer. A Multi-center, Phase I, Open-label, i.v. Infusion Study
Study Start Date : May 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: Claudiximab Drug: Claudiximab

Patients receive Claudiximab as intravenous infusion over 2 hours on day 1. Cohorts of 3-6 patients receive escalating doses of Claudiximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no dose-limiting toxicity (DLT) is diagnosed in 3 patients or no more than 1 out of 6 patients exhibits a DLT.

After completion of study treatment, patients are followed for 4 weeks.

Primary Outcome Measures :
  1. Determination of maximum tolerated dose of claudiximab (Phase I: toxicities as assessed by NCI CTCAE version 3.0) [ Time Frame: Four weeks ]

Secondary Outcome Measures :
  1. Determination of the safety profile [ Time Frame: Four weeks ]
  2. Pharmacokinetic evaluation [ Time Frame: Four weeks ]
  3. Overall tumor response as assessed by RECIST [ Time Frame: Four weeks ]
  4. Evaluation of immunogenicity [ Time Frame: Four weeks ]
  5. Determination of antitumoral efficacy [ Time Frame: Four weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Metastatic, refractory or recurrent disease of advanced gastroesophageal cancer (adenocarcinoma) proven by histology
  • CLDN18.2 expression confirmed by immunohistochemistry
  • Prior standard chemotherapy containing a fluoropyrimidine, a platinum compound and/or epirubicine, and - if clinically appropriate - docetaxel
  • At least 1 measurable site of the disease according RECIST criteria (CT-scans or MRT not older than 6 weeks before study entry)
  • Age ≥ 18 years
  • ECOG performance status (PS) 0-1 or Karnofsky Index 70-100%
  • Life expectancy > 3 months
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dl
  • INR < 1.5
  • Bilirubin normal
  • AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • Creatinine < 1.5 x ULN

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Prior allergic reaction or intolerance to a monoclonal antibody
  • Prior inclusion in the present study
  • Less than 3 weeks since prior anti-tumor or radiation therapy
  • Other investigational agents or devices concurrently or within 4 weeks prior to this study
  • Other concurrent anticancer therapies
  • History of positive test for human immunodeficiency virus (HIV) antibody
  • Known Hepatitis.
  • Uncontrolled or severe illness.
  • Concurrent administration of anticoagulation agents with vitamin K antagonists
  • Concurrent administration of therapeutic doses of heparin (prophylactic doses are acceptable)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00909025

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Universitätsklinikum Essen, Innere Klinik (Tumorforschung)
Essen, Germany, 45122
Universität Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Germany, 69120
Johannes Gutenberg Universität, 1.Med Klinik und Poliklinik
Mainz, Germany, 55131
Klinikum Rechts-der-Isar, III.Medizinische Klinik und Poliklinik
München, Germany, 81674
Piejuras Hospital
Liepaja, Latvia, 3401
Pauls Stradins University
Riga, Latvia, 1002
Sponsors and Collaborators
Ganymed Pharmaceuticals GmbH
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Principal Investigator: Martin Schuler, Innere Klinik (Tumorforschung) Universitätsklinikum Essen Hufelandstr. 55 45122 Essen, GERMANY
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ganymed Pharmaceuticals GmbH Identifier: NCT00909025    
Other Study ID Numbers: GM-IMAB-001
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: October 2012