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

NCT00909025 | Completed Phase 1 DMC

• 1 other identifier: GM-IMAB-001
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 6

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

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Determination of maximum tolerated dose of claudiximab (Phase I: toxicities as assessed by NCI CTCAE version 3.0)

  Four weeks

Secondary Outcomes (5)

• Determination of the safety profile

  Four weeks

• Pharmacokinetic evaluation

  Four weeks

• Overall tumor response as assessed by RECIST

  Four weeks

• Evaluation of immunogenicity

  Four weeks

• Determination of antitumoral efficacy

  Four weeks

Study Arms (1)

Claudiximab

EXPERIMENTAL

Drug: Claudiximab

Interventions

Claudiximab 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.

Claudiximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or breastfeeding
• Prior allergic reaction or intolerance to a monoclonal antibody
• 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)

Sponsors & Collaborators

• Ganymed Pharmaceuticals GmbH: lead

Study Sites (6)

Universitätsklinikum Essen, Innere Klinik (Tumorforschung)

Essen, 45122, Germany

Location

Universität Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, 69120, Germany

Location

Johannes Gutenberg Universität, 1.Med Klinik und Poliklinik

Mainz, 55131, Germany

Location

Klinikum Rechts-der-Isar, III.Medizinische Klinik und Poliklinik

München, 81674, Germany

Location

Piejuras Hospital

Liepāja, 3401, Latvia

Location

Pauls Stradins University

Riga, 1002, Latvia

Location

Related Publications (1)

• Sahin U, Schuler M, Richly H, Bauer S, Krilova A, Dechow T, Jerling M, Utsch M, Rohde C, Dhaene K, Huber C, Tureci O. A phase I dose-escalation study of IMAB362 (Zolbetuximab) in patients with advanced gastric and gastro-oesophageal junction cancer. Eur J Cancer. 2018 Sep;100:17-26. doi: 10.1016/j.ejca.2018.05.007. Epub 2018 Jun 21.

  PMID: 29936063 DERIVED

Related Links

• 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

MeSH Terms

Interventions

zolbetuximab

Study Officials

• Martin Schuler, Prof.Dr.med.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 27, 2009
• Study Start: May 31, 2009
• Primary Completion: May 31, 2010
• Study Completion: May 31, 2010
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); LA (2)