Study summary

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 tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM, and health-related quality of life (HRQoL).

Additional Study Details

Phase
Phase 2
Product
zolbetuximab
Product
zolbetuximab
nab-paclitaxel
gemcitabine
Type
Interventional
Masking
None (Open Label)
Enrollment number
393
Show Additional Study Details

Get more information

Would you like more information about clinical trial sites that are recruiting participants for A Study to Assess the Efficacy 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? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
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  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

    Locations

    Contact Us
    Contact Us
    Active, not recruiting
    Memorial Sloan-Kettering Cancer Center
    New York, NY, United States, 10022
    Active, not recruiting
    Site JP81007
    Nagoya, Aichi, Japan
    Active, not recruiting
    Site FR33010
    Brest, Brest Cedex, France, 9GV7+4G
    Active, not recruiting
    Site JP81006
    Yokohama, Kanagawa, Japan
    Completed
    Site ES34005
    Lleida, Lleida, Spain, 25198
    Completed
    Ochsner Health System
    New Orleans, LA, United States, 70121
    Completed
    Site ES34014
    Caceres, Caceres, Spain, 10003
    Withdrawn
    University of Kansas Cancer Center
    Westwood, KS, United States, 66205
    Withdrawn
    Cancer Treatment Centers of America, Chicago
    Zion, IL, United States, 60099
    Active, not recruiting
    Site IT39003
    Milan, Milan, Italy, 20141
    Completed
    Lynn Cancer Institute
    Boca Raton, Florida, United States, 33486
    Completed
    Site ES34004
    Llobregat, Barcelona, Spain, 08908
    Completed
    Site FR33008
    Besancon, Besancon Cedex, France, 6XG7+42
    Completed
    Northwell Health Cancer Institute
    Lake Success, NY, United States, 11042
    Active, not recruiting
    Site JP81004
    Fukuoka, Fukuoka, Japan
    Completed
    Baptist Health
    Miami, FL, United States, 33176
    Completed
    Site AU61008
    Gosford, New South Wales, Australia, NSW 2250
    Withdrawn
    Mercy Clinic Oklahoma Communities, Inc
    Oklahoma City, OK, United States, 73120
    Completed
    Site JP81005
    Sapporo, Hokkaido, Japan
    Completed
    Site IT39004
    Candiolo, Torino, Italy, 10060
    Active, not recruiting
    Site KR82002
    Seoul, Seoul, Republic of Korea, F3QP+76
    Active, not recruiting
    Site ES34013
    Barcelona, Barcelona, Spain, 08036
    Withdrawn
    PMG Research of McFarland Clinic
    Ames, IA, United States, 50010
    Withdrawn
    Site FR33004
    Saint-Étienne, Cedex 02, France, 42000
    Active, not recruiting
    Site JP81011
    Bunkyo-ku, Tokyo, Japan
    Withdrawn
    Site TW88607
    Tainan City, Liuying District, Taiwan, Province of China, 73657
    Withdrawn
    Cancer Treatment Centers of Phoenix
    Goodyear, AZ, United States, 85338
    Active, not recruiting
    Site FR33003
    Aquitaine, Pessac, France, 33604
    Completed
    Site KR82001
    Seoul, Seoul, Republic of Korea, 03080
    Active, not recruiting
    Site KR82005
    Seongnam-Si, Gyeonggi-do, Republic of Korea, 013620
    Active, not recruiting
    Site KR82003
    Seoul, Seoul, Republic of Korea, 120-752
    Completed
    Site ES34015
    Madrid, Madrid, Spain, 28027
    Active, not recruiting
    Site KR82006
    Seoul, Seoul, Republic of Korea, G234+36
    Completed
    Site ES34009
    Madrid, Madrid, Spain, 28034
    Withdrawn
    Our Lady of the Lake
    Baton Rouge, LA, United States, 70809
    Completed
    Site FR33017
    Rouen, Normandy, France, 76000
    Withdrawn
    Site ES34012
    Madrid, Madrid, Spain, 28046
    Withdrawn
    Scott and White Memorial Hospital
    Temple, TX, United States, 76508
    Withdrawn
    Site ES34008
    Madrid, Madrid, Spain, 28050
    Active, not recruiting
    Site IR35301
    Elm Park, Dublin, Ireland, D04 T6F4
    Completed
    Site AU61007
    Wollongong, New South Wales, Australia, HVGM+3C
    Completed
    Site ES34006
    Madrid, Madrid, Spain, 28033
    Active, not recruiting
    Site FR33009
    Nancy, Nancy Cedex, France, 54000
    Active, not recruiting
    Site KR82007
    Seoul, Seoul, Republic of Korea, 152-703
    Withdrawn
    UCLA Hematology Oncology
    Santa Monica, CA, United States, 90404
    Completed
    TOI Clinical research
    Whittier, CA, United States, 90603
    Completed
    David C Pratt Cancer Center
    Creve Coeur, Mo, United States, 63141
    Active, not recruiting
    Site FR33015
    Caen, Cedex 5, France, 14076
    Active, not recruiting
    Houston Methodist Hospital
    Houston, TX, United States, 77030
    Completed
    Site IT39002
    Cremona, Cremona, Italy, 26100
    Completed
    Site FR33006
    Chambray, cedex 9, France, 37170
    Withdrawn
    Site ES34016
    Madrid, Madrid, Spain, 28027
    Completed
    Site ES34007
    Barcelona, Barcelona, Spain, 08916
    Active, not recruiting
    Site JP81001
    Kashiwa, Chiba, Japan
    Withdrawn
    Site TW88604
    Tainan, East District, Taiwan, Province of China, 70457
    Withdrawn
    Site TW88606
    Taoyuan, Guishan District, Taiwan, Province of China, 83301
    Active, not recruiting
    Site KR82004
    Seoul, Seoul, Republic of Korea, 138-736
    Withdrawn
    Site FR33011
    Dijon, Dijon Cedex, France, 21079
    Completed
    MultiCare Regional Cancer Center - Gig Harbor
    Gig Harbor, WA, United States, 98335
    Completed
    Site FR33014
    Plerin, Plerin, France, 22190
    Completed
    Site JP81010
    Osaka, Osaka, Japan
    Completed
    Site AU61005
    Fitzroy, Victoria, Australia, 5XRF+WX
    Completed
    Site JP81012
    Chuo-ku, Tokyo, Japan
    Withdrawn
    Cancer Treatment Centers of America at Eastern Regional Medical Center
    Philadelphia, PA, United States, 19124
    Withdrawn
    Site TW88605
    Taipei City, Taiwan, Taiwan, Province of China, 2GR9+7H
    Completed
    Roswell Park Cancer Institute
    Buffalo, NY, United States, 14203
    Completed
    Site AU61006
    Warrnambool, Victoria, Australia, VIC 3280
    Active, not recruiting
    Site FR33002
    Grenoble, France
    Active, not recruiting
    Midstate Medical Center
    Meriden, CT, United States, 06451
    Withdrawn
    Site ES34011
    A Coruna, Galicia, Spain, 15009
    Active, not recruiting
    Site FR33007
    Strasbourg, Strasbourg, France, 67000
    Active, not recruiting
    Site JP81013
    Mitaka, Tokyo, Japan
    Withdrawn
    Site TW88603
    Tainan City, Taiwan, Taiwan, Province of China, 26CC+4Q
    Active, not recruiting
    Site FR33012
    Herblain, Herblain Cedex, France, 44805
    Active, not recruiting
    St. Joseph Heritage Medical Group
    Fullerton, CA, United States, 92835
    Active, not recruiting
    Site FR33005
    Pringy Cedex, France, 74374
    Active, not recruiting
    Site ES34003
    Pamplona, Navarra, Spain, 31008
    Active, not recruiting
    Site TW88601
    Taipei City, Taiwan, Taiwan, Province of China, 4G9C+W3
    Completed
    Site FR33016
    La Chaussee Saint Victor, Loir-et-Cher, France, 41260
    Withdrawn
    Site ES34002
    Girona, Spain, 17007
    Withdrawn
    The University of Chicago
    Chicago, IL, United States, 60637
    Active, not recruiting
    Site FR33013
    Villejuif, Villejuif Cedex, France, 94805
    Completed
    Site IT39006
    Rozzano, Milan, Italy, 20089
    Withdrawn
    Site IE35303
    Cork, Cork, Ireland, T12 DV56
    Active, not recruiting
    Site TW88602
    Taichung City, Taiwan, Taiwan, Province of China, 5M5J+36
    Completed
    Site FR33001
    Bayonne Cedex, France, 64109
    Completed
    Site ES34010
    Barcelona, Barcelona, Spain, 08028
    Completed
    Cancer Treatment Centers of Atlanta
    Newnan, GA, United States, 30265
    Withdrawn
    Site ES34001
    Sabadell, Barcelona, Spain, 8208
    Withdrawn
    Site AU61002
    North Adelaide, South Australia, Australia, 5006
    Completed
    Utah Cancer Specialists
    Salt Lake City, UT, United States, 84106
    Active, not recruiting
    Site JP81002
    Shinjuku-ku, Tokyo, Japan
    Completed
    Site JP81003
    Kashihara, Nara, Japan
    Withdrawn
    Site JP81008
    Suita, Osaka, Japan
    Completed
    Site JP81009
    Wakayama, Wakayama, Japan
    Completed
    Site JP81014
    Koto-ku, Tokyo, Japan
    Active, not recruiting
    Site JP81015
    Ube, Yamaguchi, Japan
    Withdrawn
    Oncology Consultants PA
    Houston, Texas, United States, 77024
    Completed
    Site KR82008
    Suwon-si, Gyeonggi-do, Republic of Korea
    Completed
    Site TR90003
    Diyarbakir, Turkey
    Completed
    Site TR90004
    Ankara, Turkey
    Completed
    Site TR90006
    Ankara, Turkey
    Active, not recruiting
    Site CN86013
    Shanghai, China
    Active, not recruiting
    Site CN86001
    Beijing, China
    Active, not recruiting
    Site CN86003
    Zhejiang, China
    Active, not recruiting
    Site CN86002
    Hubei, China
    Completed
    Site CN86007
    Tianjin, China
    Active, not recruiting
    Site CN86006
    Shanghai, China
    Completed
    Site CN86008
    Beijing, China
    Completed
    Site TR90002
    Istanbul, Turkey
    Completed
    Vista Oncology
    Olympia, Washington, United States, 98502
    Withdrawn
    Site TR90005
    Istanbul, Turkey
    Completed
    Site TR90001
    Konya, Turkey
    Completed
    Site IT39008
    Veneto, Italy
    Completed
    Site FR33019
    Roche-Sur-Yon, France
    Withdrawn
    Site FR33020
    Lyon Cedex, France
    Active, not recruiting
    Site CN86024
    Shan Xi, China
    Active, not recruiting
    Site IT39010
    Lombardia, Italy
    Completed
    Site CN86011
    Jiangsu, China
    Completed
    Site CN86018
    Zhejiang, China
    Active, not recruiting
    Site KR82010
    Daegu, Republic of Korea
    Completed
    Site KR82011
    Jeollanam-do, Republic of Korea
    Withdrawn
    Site IT39012
    Lazio, Italy
    Completed
    Site CN86020
    Guangdong, China
    Active, not recruiting
    Site IT39014
    Toscana, Italy
    Completed
    Site CN86005
    Jiangsu, China
    Active, not recruiting
    Site CN86004
    Guangdong, China
    Active, not recruiting
    Site CN86010
    Zhengzhou, China
    Completed
    Site CN86025
    Jiangsu, China
    Completed
    Site FR33018
    Bordeaux, France
    Completed
    Site KR82009
    Gyeonggi-do, Republic of Korea
    Active, not recruiting
    Site FR33023
    Pierre Benite, France
    Active, not recruiting
    Site CN86012
    Harbin, China
    Completed
    Site CN86014
    Beijing, China
    Active, not recruiting
    Virginia Mason
    Seattle, Washington, United States, 98101
    Active, not recruiting
    Site MX52003
    San Luis Potosi, Mexico
    Withdrawn
    Site CN86017
    Shijiazhuang, China
    Completed
    Norton Cancer Institute (NCI)
    Louisville, Kentucky, United States, 40202
    Withdrawn
    Site ES34020
    Madrid, Spain
    Withdrawn
    Site IT39009
    Ancona, Italy
    Completed
    Site CN86019
    Shanghai, China
    Completed
    Site TW88608
    New Taipei City, Taiwan, Province of China
    Active, not recruiting
    Site TW88609
    Taipei City, Taiwan, Province of China
    Active, not recruiting
    Site CN86022
    Xinjiang, China
    Completed
    Site CN86023
    Shandong, China
    Withdrawn
    Site BR55003
    Itajai, Brazil
    Active, not recruiting
    Site BR55004
    Santa Catarina, Brazil
    Completed
    Site BR55008
    Rio Grande do Sul, Brazil
    Active, not recruiting
    Site MX52004
    Distrito Federal, Mexico
    Active, not recruiting
    Site MX52005
    Veracruz, Mexico
    Active, not recruiting
    Site CN86009
    Chongqing, China
    Completed
    Site CN86016
    Guangzhou, China
    Active, not recruiting
    Site CN86026
    Changchun, China
    Active, not recruiting
    Site FR33021
    Nice Cedex 2, France
    Completed
    Site ES34021
    Barcelona, Spain
    Completed
    Memorial Sloan Kettering Bergen
    Montvale, New Jersey, United States, 07645
    Completed
    Memorial Sloan Kettering Commack
    Commack, New York, United States, 11725
    Active, not recruiting
    Memorial Sloan Kettering Basking Ridge
    Basking Ridge, New Jersey, United States, 07920
    Completed
    Memorial Sloan Kettering Westchester
    West Harrison, New York, United States, 10604
    Active, not recruiting
    Memorial Sloan Kettering Nassau
    Uniondale, New York, United States, 11553
    Withdrawn
    Memorial Sloan Kettering Monmouth
    Middletown, New Jersey, United States, 07748
    Withdrawn
    Holden Comprehensive Cancer Center
    Iowa City, Iowa, United States, 52242
    Withdrawn
    Inova Dwight and Martha Schar
    Fairfax, Virginia, United States, 22031
    Completed
    Site ES34018
    Barcelona, Spain
    Withdrawn
    Site BR55001
    Sao Paulo, Brazil
    Withdrawn
    Hoag Hospital
    Newport Beach, CA, United States, 92663
    Withdrawn
    Site BR55002
    Porto Alegre, Brazil
    Withdrawn
    Site BR55006
    Sao Paulo, Brazil
    Withdrawn
    Site IT39015
    Bologna, Italy
    Completed
    University of Illinois at Chicago
    Chicago, IL, United States, 60612
    Completed
    Site ES34017
    Santiago de Compostela, Spain
    Active, not recruiting
    Site ES34026
    Malaga, Spain
    Completed
    Site ES34024
    Santander, Spain
    Withdrawn
    Site ES34025
    Castello de la plana, Spain
    Completed
    Novant Health Presbyterian Medical Center
    Charlotte, North Carolina, United States, 28204
    Completed
    Novant Health
    Winston-Salem, North Carolina, United States, 27103
    Withdrawn
    St Vincent's Frontier Cancer Center
    Billings, Montana, United States, 59102
    Completed
    Site ES34022
    Cordoba, Spain
    Completed
    Site BR55009
    Centro Passo Fundo, Brazil
    Active, not recruiting
    Site BR55010
    Sao Paulo, Brazil
    Active, not recruiting
    Site BR55011
    Sao Paulo, Brazil
    Withdrawn
    Site ES34019
    Zaragoza, Spain
    Completed
    Site BR55012
    Porto Alegre, Rio Grande Do Sul, Brazil

    Frequently Asked Questions

    Are clinical trials only for people with advanced cancer?

    While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

    Will I have to stop my current treatment to participate in a clinical trial?

    Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

    Should I be worried about getting a placebo?

    In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

    Do I need a referral from my doctor to take part in a study?

    Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

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