A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX Regimen (Plus ZA/IL-2) as First-Line Treatment of Patients With CLDN18.2-positive Adenocarcinomas of the Stomach, the Esophagus or the Gastroesophageal Junction.
18 Years
N/A
Both
CLDN18.2-positive Gastric Adenocarcinoma, CLDN18.2-positive Adenocarcinoma of Esophagus, CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction
Trial Information
A Randomized Phase II Multicenter, Open-Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination With the EOX Regimen (Plus ZA/IL-2) as First-Line Treatment of Patients With CLDN18.2-positive Adenocarcinomas of the Stomach, the Esophagus or the Gastroesophageal Junction.
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the stomach, the esophagus or the
gastroesophageal junction
- Inoperable locally advanced disease or resections with R2 outcome or recurrent or
metastatic disease.
- CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor
tissue sample.
- Measurable and/or non-measurable disease as defined according to RECISTv1.1
- Age ≥ 18 years
- Written Informed Consent Form
- ECOG performance status (PS) 0-1
- Life expectancy > 3 months
- HER2/neu negative patients and patients with HER2/neu positive status but not
eligible to trastuzumab therapy in discretion of the investigator.
- Adequate cardiac, hepatic, renal, hematologic function.
Exclusion Criteria:
- Prior severe allergic reaction or intolerance to a monoclonal antibody, to the
chemotherapeutics used in this study or any excipient in the respective formulations.
- Previous chemotherapy for advanced disease.
- Previous perioperative chemotherapy with curative intention within 6 months of start
of study treatment. If interval is longer than 6 months, patients are allowed.
- Known HIV infection or known symptomatic hepatitis (A, B, C).
- Symptomatic cerebral metastases.
- Pregnancy or breastfeeding.
- Previous treatments with maximum cumulative doses of epirubicin > 500 mg/m² and/or
other anthracyclines and anthracenediones.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival (PFS)
Outcome Description:
PFS is defined as the time from randomization of therapy to the first observation of disease progression or death from any cause or last tumor evaluation if free of progression. For patients who have not progressed either clinically or on the last scan, they will be censured as of the last tumor evaluation.
Outcome Time Frame:
at least 33 months
Safety Issue:
No
Principal Investigator
Martin Schuler, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universitätsklinikum Essen; Innere Klinik Tumorforschung; Hufelandstrasse 55, 45122 Essen
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
GM-IMAB-001-03
NCT ID:
NCT01630083
Start Date:
June 2012
Completion Date:
April 2015
Related Keywords:
- CLDN18.2-positive Gastric Adenocarcinoma
- CLDN18.2-positive Adenocarcinoma of Esophagus
- CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Stomach Neoplasms
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