Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer

Ganymed Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Solid Tumors

Treatments: Drug: IMAB362

Study type: Interventional

Funder types: Industry

Identifiers

NCT01197885

GM-IMAB-001-02

2009-017365-36 (EudraCT Number)

Details and patient eligibility

About

IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma. Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metastatic, refractory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology
• CLDN18.2 expression of the biopsy material from the cancer confirmed by immunohistochemistry
• At least 1 measurable site of disease according to RECIST criteria

Exclusion criteria

• Less than 3 weeks since prior chemo-or radiation therapy
• Other concurrent anticancer therapies
• Concurrent anticoagulation with vitamin K antagonists
• Therapeutic doses of Heparin (prophylactic doses accepted)
• Uncontrolled or severe illness

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

IMAB362

Experimental group

Description:

Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially.

Treatment:

Drug: IMAB362