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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

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

Outcome Time Frame:

Four weeks

Safety Issue:

Yes

Principal Investigator

Martin Schuler, Prof.Dr.med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

GM-IMAB-001

NCT ID:

NCT00909025

Start Date:

May 2009

Completion Date:

May 2010

Related Keywords:

  • Solid Tumors

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