Last updated on August 2020

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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Bayonne Cedex, France
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Grenoble, France
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Pringy Cedex, France
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Sabadell, Spain
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Pamplona, Spain
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David C Pratt Cancer Center

Creve Coeur, MO United States
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Saint-Étienne, France
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Llobregat, Spain
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Saint-Étienne, France
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Saint-Étienne, France
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Barcelona, Spain
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Saint-Étienne, France
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Saint-Étienne, France
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Aquitaine, France
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Site ES34007

Barcelona, Spain
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Saint-Étienne, France
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Saint-Étienne, France
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Saint-Étienne, France
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Saint-Étienne, France
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Strasbourg, France
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Seongnam-Si, Korea, Republic of
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Seoul, Korea, Republic of
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Seoul, Korea, Republic of
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Site KR82004

Seoul, Korea, Republic of
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Site KR82007

Seoul, Korea, Republic of
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Site FR33004

Saint-Étienne, France
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Lynn Cancer Institute

Boca Raton, FL United States
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The University of Chicago

Chicago, IL United States
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Wollongong, Australia
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Site AU61002

North Adelaide, Australia
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Fitzroy, Australia
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Besancon, France
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Saint-Étienne, France
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Yokohama-shi, Japan
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Site JP81010

Osaka-shi, Japan
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Seoul, Korea, Republic of
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Seoul, Korea, Republic of
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Barcelona, Spain
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Taichung City, Taiwan
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Tainan City, Taiwan
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Taipei City, Taiwan
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Taipei City, Taiwan
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Midstate Medical Center

Meriden, CT United States
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Baptist Health

Miami, FL United States
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University of Kansas Cancer Center

Overland Park, KS United States
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Site AU61006

Warrnambool, Australia
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Site FR33004

Saint-Étienne, France
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Site JP81006

Yokohama, Japan
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Bunkyo-ku, Japan
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Houston Methodist Hospital

Houston, TX United States
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Site AU61008

Gosford, Australia
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Site FR33004

Saint-Étienne, France
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Site TW88606

Kaohsiung, Taiwan
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Site FR33004

Saint-Étienne, France
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UCLA Hematology Oncology

Burbank, CA United States
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Oncology Consultants PA

Houston, TX United States
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Site FR33004

Saint-Étienne, France
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Site FR33004

Saint-Étienne, France
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Site TW88607

Tainan City, Taiwan
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Recruitment Status: Open


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