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

Study Overview
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Brief Summary
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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.

Official Title
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International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: IMAB362


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMAB362<br>Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially. | Drug: IMAB362<br>* Cohort 1 repeated doses of 300 mg/m2 Cohort 2 repeated doses of 600 mg/m2 Cohort 3 doses to be determined, 600mg/m2 or less<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of remission (CR, PR) according to RECIST Criteria |  | All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with adverse events as a measure of safety and tolerability |  | All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion | 
| Frequency and severity of adverse events according to CTCAE v3.0 |  | All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion | 
| Progression-free-survival time (PFS) | The time from start of the first infusion to date of first observed disease progression or death due to progression (whichever is first) | All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion |