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 - IMAB362 clinical study phase IIa-01 - GM-IMAB-001-02

Phase 1

• Conditions: advanced adenocarcinoma of the stomach or the lower esophagus; MedDRA version: 12.1Level: LLTClassification code 10001173Term: Adenocarcinoma of esophagus; MedDRA version: 12.1Level: LLTClassification code 10001150Term: Adenocarcinoma gastric

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-21
• Study Completion: 2015-08-13
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

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 with at least 50 % with at least 2 + (double intensity) staining intensity confirmed by immunohistochemistry,
- At least 1 measureable site of disease according to RECIST criteria (CT scans or MRI not older than 2 weeks before visit 2),
- Age = 18 years,
- Informed consnet,
- 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 eith 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 sinde 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 antagonists (e. g. Coumadin, Marcumar),
- Therapeutic doses of heparin (prophylactic doses are accepted),
- Uncontrolled illness including, but nor 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 arrhytmia
-- Myocardial infarction within the past 6 months
-- Gastric bleeding within last four weeks
-- Symptomatic peptic ulcer
-- Clinical symptoms of cerebral metastasis or documented metastasis
-- Psychiatric illness
-- situations that would preclude study compliance

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: - Determine antitumoral activity of IMAB362 as monotherapy in patients with metastatic, refactory 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<br>- Determine pharmacokinetics and immunogenicity after repeat dosing;Primary end point(s): Rate of remission (CR, PR) (RECIST Criteria),<br>Evaluation of antitumoral activity by CT or MRI before start of therapy and after week 10 and week 16.<br>Patients receiving continued treatment will be evaluated by CT or MRI in 8-12 weeks intervals until 6 month after last infusion.