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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Claudiximab

Group Type EXPERIMENTAL

Claudiximab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No