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

Ganymed Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Claudiximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909025

GM-IMAB-001

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Claudiximab

Experimental group

Treatment:

Drug: Claudiximab