Last updated on July 2019

A Study to Assess the Antitumor Activity and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive Metastatic Pancreatic Adenocarcinoma


Brief description of study

The purpose of this study is to confirm the recommended phase 2 dose (RP2D) of zolbetuximab in combination with Nab-P + GEM, determine overall survival and assess the safety and tolerability of the combination treatment.

This study will also evaluate other anti-tumor effects, tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM.

Detailed Study Description

This study will have a safety lead in phase and a randomization phase.

Clinical Study Identifier: NCT03816163

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Ochsner Health System

New Orleans, LA United States
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Northwell Health Cancer Institute

Lake Success, NY United States
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Site FR33006

Chambray, France
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Site FR33001

Bayonne Cedex, France
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Site FR33002

Grenoble, France
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Site FR33005

Pringy Cedex, France
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Site ES34001

Sabadell, Spain
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Site ES34003

Pamplona, Spain
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David C Pratt Cancer Center

Creve Coeur, MO United States
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Site FR33004

Saint-Étienne, France
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Site ES34004

Llobregat, Spain
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Site FR33004

Saint-Étienne, France
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Site FR33004

Saint-Étienne, France
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Site ES34013

Barcelona, Spain
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Site FR33004

Saint-Étienne, France
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Site FR33004

Saint-Étienne, France
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Site FR33003

Aquitaine, France
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Site ES34007

Barcelona, Spain
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Site FR33004

Saint-Étienne, France
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Recruitment Status: Open


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