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

Phase 1

• Conditions: advanced adenocarcinoma of the stomach or the lower esophagus; MedDRA version: 14.1Level: LLTClassification code 10001173Term: Adenocarcinoma of esophagusSystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 100000004864

• Registration Number: EUCTR2009-017365-36-LV
• Lead Sponsor: GANYMED Pharmaceuticals AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-28
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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 < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present),
- Creatinine < 1.5 x ULN,
- For women with childbearing potential (last menstruation less than 2 years prior to enrolment): Negative pregnancy test (ß-HCG) at baseline and using two highly effective methods of contraception during the treatment phase and for 8 weeks after the last infusion of the study drug.
- Male patients whose sexual partners are women of child bearing potential must use an accepted contraceptive method during the treatment phase and for 8 weeks after the last infusion of the study drug.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified