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

    Phase 1
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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
Study Started
May 31
Primary Completion
May 31
Study Completion
May 31
Last Update
Jul 02

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.

Claudiximab Experimental


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)
No Results Posted