Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer
This study has been completed.
Sponsor:
Ganymed Pharmaceuticals AG
Information provided by (Responsible Party):
Ganymed Pharmaceuticals AG
ClinicalTrials.gov Identifier:
NCT00909025
First received: May 18, 2009
Last updated: October 12, 2012
Last verified: October 2012
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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 1 |
| 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:
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 ]
| 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) |
| Arms | Assigned Interventions |
|---|---|
| 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. |
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: | 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: | October 12, 2012 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
ClinicalTrials.gov processed this record on May 23, 2013