advanced adenocarcinoma of the stomach or the lower esophagus MedDRA version: 14.1 Level: LLT Classification code 10001173 Term: Adenocarcinoma of esophagus System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10001150 Term: Adenocarcinoma gastric System Organ Class: 100000004864
Conditions
Interventions
Product Name: IMAB362
Product Code: iMAB-362
Pharmaceutical Form: Powder and solvent for solution for infusion
Current Sponsor code: iMAB-362
Other descriptive name: monoclonal IgG1 antibody
Concentra
Sponsors
GANYMED Pharmaceuticals AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Metastatic, refractory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology, - CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample in at least 50 % of the tumor cells with a staining of at least 2+ (on a scale from 0 to +3), - At least 1 measurable site of disease according to RECIST criteria (CT scans or MRI not older than 2 weeks before visit 2), - Age = 18 years, - Written Informed consent, - ECOG performance status (PS) 0-1 or Karnofsky Index 70-100%, - Life expectancy > 3 months, - Platelet count = 100,000/mm³, - Hemoglobin = 10 g/dl, - Bilirubin normal, - AST and ALT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients meeting any one or more of the following exclusion criteria are not eligible for study entry: - Pregnancy or breastfeeding, - Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies, - Less than 3 weeks since prior chemo- or radiation therapy, - Other investigational agents or devices concurrently or within 4 weeks prior to this study, - Other concurrent anticancer therapies (not for the indication under study treatment), - known HIV infection or known active hepatitis (A, B, C), - Concurrent anticoagulation with vitamin K antagoninsts (e. g. Coumadin, Marcumar), - Therapeutic doses of heparin (prophylactic doses are accepted), - Uncontrolled illness including, but not limited to, any of the following: -- Ongoing or active infection requiring parenteral antibiotics -- Symptomatic congestive heart failure -- Unstable angina pectoris -- Uncontrolled hypertension -- Clinically significant cardiac arrhythmia -- Myocardial infarction within the past 6 months -- Gastric bleeding within last four weeks -- Symptomatic peptic ulcer -- Clinical symptoms of cerebral metastasis - Psychiatric illness or social situations that would preclude study compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Determine antitumoral activity of IMAB362 as monotherapy in patients with metastatic, refractory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology;Secondary Objective: • Determine profile of adverse effects, safety and tolerability of repeated application • Determine pharmacokinetics and immunogenicity after repeated dosing ;Primary end point(s): Rate of remission (CR, PR) (RECIST Criteria), Evaluation of antitumoral activity by CT or MRI before start of therapy and at visit 9 and visit 10. Patients receiving continued treatment will be evaluated by CT or MRI in 8-12 weeks intervals. All patients will be additionally evaluated by CT or MRI at visit 11 and visit 12. | — |
Countries
Austria, Bulgaria, Germany, Latvia, Lithuania, Switzerland
Outcome results
None listed