Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer - Full Text View

Sponsor:	Ganymed Pharmaceuticals AG
Information provided by:	Ganymed Pharmaceuticals AG
ClinicalTrials.gov Identifier:	NCT00909025

Purpose

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	Intervention	Phase
Solid Tumors	Drug: Claudiximab	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Ganymed Pharmaceuticals AG:

Primary Outcome Measures:

Determination of maximum tolerated dose of claudiximab (Phase I: toxicities as assessed by NCI CTCAE version 3.0) [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determination of the safety profile [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
Pharmacokinetic evaluation [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
Overall tumor response as assessed by RECIST [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
Evaluation of immunogenicity [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
Determination of antitumoral efficacy [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	May 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909025

Locations

Germany
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
Latvia
Piejuras Hospital
Liepaja, Latvia, 3401
Pauls Stradins University
Riga, Latvia, 1002

Sponsors and Collaborators

Ganymed Pharmaceuticals AG

Investigators

Principal Investigator:

Martin Schuler, Prof.Dr.med.

Innere Klinik (Tumorforschung) Universitätsklinikum Essen Hufelandstr. 55 45122 Essen, GERMANY

More Information

No publications provided

Responsible Party:	Eveline Förster, Manager Clinical Research, GANYMED Pharmaceuticals AG
ClinicalTrials.gov Identifier:	NCT00909025 History of Changes
Other Study ID Numbers:	GM-IMAB-001
Study First Received:	May 18, 2009
Last Updated:	June 11, 2010
Health Authority:	Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on February 09, 2012