New drug combo shows promise in tough pancreatic cancer battle

NCT ID NCT03816163

Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests whether adding zolbetuximab to standard chemotherapy helps people with metastatic pancreatic cancer live longer. Zolbetuximab targets a protein (CLDN18.2) found in most pancreatic tumors, helping the immune system attack the cancer. About 393 adults whose cancer has spread and has this marker will be randomly assigned to get either the drug combo or chemo alone. The study is active but no longer enrolling, and the program is ending in 2025.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

393 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A female subject is eligible to participate if she is not pregnant or lactating and at least 1 of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration. * Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration. * Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration. * A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration. * A male subject must not donate sperm during the treatment period and for at least 6 months after the final study drug administration. * Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration. * Subject agrees not to participate in other interventional studies while receiving study drug in present study. * Subject has histologically or cytologically confirmed adenocarcinoma of pancreas. * Subjects must have metastatic pancreatic adenocarcinoma that has not been previously treated with chemotherapy. * Prior treatment with fluorouracil (5-FU) or GEM administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed * If a subject received adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the adjuvant therapy. * Subjects whose disease progressed on prior treatment with Nab-P and GEM are not eligible. * Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to randomization. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy. * Subject's tumor sample has CLDN18.2 expression in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing * Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subject has predicted life expectancy ≥ 12 weeks. * Subject must meet all of the following criteria based on the laboratory tests that will be collected within 14 days prior to randomization. In case of multiple laboratory data within this period, the most recent data should be used. * Hemoglobin ≥ 9 g/dl (no transfusion within 14 days of start of study treatment) * Absolute neutrophil count ≥ 1.5 x 10\^9/L * Platelets ≥ 100 x 10\^9/L * Albumin ≥ 2.5 g/dL * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (≤ 5 x ULN if liver metastases are present) * Estimated creatinine clearance ≥ 30 mL/min * Prothrombin time/international normalized ratio (INR) and partial thromboplastin time ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy) Exclusion Criteria: * Subject has received other investigational treatment within 28 days prior to randomization. * Subject has received radiotherapy for metastatic pancreatic adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity. * Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subject using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed. * Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibody, including humanized or chimeric antibodies. * Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment. * Subject has a known history of a positive test for human immunodeficiency virus infection or known active hepatitis B (positive HBs antigen \[Ag\]) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements. 1. For subjects who are negative for HBs Ag, but hepatitis B core antibody positive, a hepatitis B virus DNA test will be performed and if positive, the subject will be excluded. 2. Subjects with positive hepatitis C serology but negative hepatitis C virus RNA test results are eligible. 3. Subjects treated for hepatitis C with undetectable viral load results are eligible. * Subject has a history of interstitial pneumonia or pulmonary fibrosis. * Subject has pleural effusion or ascites ≥ Grade 3. * Subject has an active autoimmune disease that has required systemic treatment in the past 3 months prior to randomization. * Subject has active infection requiring systemic therapy that has not completely resolved per investigator judgment within 7 days prior to randomization. * Subject has significant cardiovascular disease, including: * Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization; * History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes); * QTc interval \> 450 msec for male subjects; QTc interval \> 470 msec for female subjects; * Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for \> 1 month prior to randomization.) * Subject has a history of central nervous system metastases and/or carcinomatous meningitis from pancreatic adenocarcinoma. * Subject has known peripheral sensory neuropathy ≥ Grade 2 unless the absence of deep tendon reflexes is the sole neurological abnormality. * Subject has had a major surgical procedure ≤ 28 days prior to randomization. * Subject without complete recovery from a major surgical procedure ≤ 14 days prior to randomization. * Psychiatric illness or social situations that would preclude study compliance. * Subject has another malignancy for which treatment is required. * Subject has any concurrent disease, infection or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic pancreatic adenocarcinoma Metastatic pancreatic cancer Pancreatic cancer

Contacts and locations

Locations

Baptist Health

Miami, Florida, 33176, United States
Cancer Treatment Centers of Atlanta

Newnan, Georgia, 30265, United States
David C Pratt Cancer Center

Creve Coeur, Missouri, 63141, United States
Houston Methodist Hospital

Houston, Texas, 77030, United States
Lynn Cancer Institute

Boca Raton, Florida, 33486, United States
Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack

Commack, New York, 11725, United States
Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States
Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States
Memorial Sloan-Kettering Cancer Center

New York, New York, 10022, United States
Midstate Medical Center

Meriden, Connecticut, 06451, United States
MultiCare Regional Cancer Center - Gig Harbor

Gig Harbor, Washington, 98335, United States
Northwell Health Cancer Institute

Lake Success, New York, 11042, United States
Norton Cancer Institute (NCI)

Louisville, Kentucky, 40202, United States
Novant Health

Winston-Salem, North Carolina, 27103, United States
Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States
Ochsner Health System

New Orleans, Louisiana, 70121, United States
Roswell Park Cancer Institute

Buffalo, New York, 14203, United States
Site AU61005

Fitzroy, Victoria, 5XRF+WX, Australia
Site AU61006

Warrnambool, Victoria, VIC 3280, Australia
Site AU61007

Wollongong, New South Wales, HVGM+3C, Australia
Site AU61008

Gosford, New South Wales, NSW 2250, Australia
Site BR55004

Santa Catarina, Brazil
Site BR55008

Rio Grande, Brazil
Site BR55009

Centro Passo Fundo, Brazil
Site BR55010

São Paulo, Brazil
Site BR55011

São Paulo, Brazil
Site BR55012

Porto Alegre, Rio Grande do Sul, Brazil
Site CN86001

Beijing, China
Site CN86002

Hubei, China
Site CN86003

Zhejiang, China
Site CN86004

Guangdong, China
Site CN86005

Jiangsu, China
Site CN86006

Shanghai, China
Site CN86007

Tianjin, China
Site CN86008

Beijing, China
Site CN86009

Chongqing, China
Site CN86010

Zhengzhou, China
Site CN86011

Jiangsu, China
Site CN86012

Harbin, China
Site CN86013

Shanghai, China
Site CN86014

Beijing, China
Site CN86016

Guangzhou, China
Site CN86018

Zhejiang, China
Site CN86019

Shanghai, China
Site CN86020

Guangdong, China
Site CN86022

Xinjiang, China
Site CN86023

Shandong, China
Site CN86024

Shanxi, China
Site CN86025

Jiangsu, China
Site CN86026

Changchun, China
Site ES34003

Pamplona, Navarre, 31008, Spain
Site ES34004

Llobregat, Barcelona, 08908, Spain
Site ES34005

Lleida, 25198, Spain
Site ES34006

Madrid, 28033, Spain
Site ES34007

Barcelona, 08916, Spain
Site ES34009

Madrid, 28034, Spain
Site ES34010

Barcelona, 08028, Spain
Site ES34013

Barcelona, 08036, Spain
Site ES34014

Cáceres, 10003, Spain
Site ES34015

Madrid, 28027, Spain
Site ES34017

Santiago de Compostela, Spain
Site ES34018

Barcelona, Spain
Site ES34021

Barcelona, Spain
Site ES34022

Córdoba, Spain
Site ES34026

Málaga, Spain
Site FR33001

Bayonne, 64109, France
Site FR33002

Grenoble, France
Site FR33003

Aquitaine, Pessac, 33604, France
Site FR33005

Pringy, 74374, France
Site FR33006

Chambray, Cedex 9, 37170, France
Site FR33007

Strasbourg, 67000, France
Site FR33008

Besançon, Besancon Cedex, 6XG7+42, France
Site FR33009

Nancy, Nancy Cedex, 54000, France
Site FR33010

Brest, Brest Cedex, 9GV7+4G, France
Site FR33012

Herblain, Herblain Cedex, 44805, France
Site FR33013

Villejuif, Villejuif Cedex, 94805, France
Site FR33014

Plérin, 22190, France
Site FR33015

Caen, Cedex 5, 14076, France
Site FR33016

La Chaussée-Saint-Victor, Loir-et-Cher, 41260, France
Site FR33017

Rouen, Normandy, 76000, France
Site FR33018

Bordeaux, France
Site FR33019

La Roche-sur-Yon, France
Site FR33021

Nice, France
Site FR33023

Pierre-Bénite, France
Site IR35301

Elm Park, Dublin, D04 T6F4, Ireland
Site IT39002

Cremona, 26100, Italy
Site IT39003

Milan, 20141, Italy
Site IT39004

Candiolo, Torino, 10060, Italy
Site IT39006

Rozzano, Milan, 20089, Italy
Site IT39008

Veneto, Italy
Site IT39010

Lombardia, Italy
Site IT39014

Toscana, Italy
Site JP81001

Kashiwa, Chiba, Japan
Site JP81002

Shinjuku-ku, Tokyo, Japan
Site JP81003

Kashihara, Nara, Japan
Site JP81004

Fukuoka, Japan
Site JP81005

Sapporo, Hokkaido, Japan
Site JP81006

Yokohama, Kanagawa, Japan
Site JP81007

Nagoya, Aichi-ken, Japan
Site JP81009

Wakayama, Japan
Site JP81010

Osaka, Japan
Site JP81011

Bunkyo-ku, Tokyo, Japan
Site JP81012

Chuo-ku, Tokyo, Japan
Site JP81013

Mitaka, Tokyo, Japan
Site JP81014

Koto-ku, Tokyo, Japan
Site JP81015

Ube, Yamaguchi, Japan
Site KR82001

Seoul, 03080, South Korea
Site KR82002

Seoul, F3QP+76, South Korea
Site KR82003

Seoul, 120-752, South Korea
Site KR82004

Seoul, 138-736, South Korea
Site KR82005

Seongnam-si, Gyeonggi-do, 013620, South Korea
Site KR82006

Seoul, G234+36, South Korea
Site KR82007

Seoul, 152-703, South Korea
Site KR82008

Suwon, Gyeonggi-do, South Korea
Site KR82009

Gyeonggi-do, South Korea
Site KR82010

Daegu, South Korea
Site MX52003

San Luis Potosí City, Mexico
Site MX52004

Distrito Federal, Mexico
Site MX52005

Veracruz, Mexico
Site TR90001

Konya, Turkey (Türkiye)
Site TR90002

Istanbul, Turkey (Türkiye)
Site TR90003

Diyarbakır, Turkey (Türkiye)
Site TR90004

Ankara, Turkey (Türkiye)
Site TR90006

Ankara, Turkey (Türkiye)
Site TW88601

Taipei, 4G9C+W3, Taiwan
Site TW88602

Taichung, 5M5J+36, Taiwan
Site TW88608

New Taipei City, Taiwan
Site TW88609

Taipei, Taiwan
St. Joseph Heritage Medical Group

Fullerton, California, 92835, United States
TOI Clinical research

Whittier, California, 90603, United States
University of Illinois at Chicago

Chicago, Illinois, 60612, United States
Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States
Virginia Mason

Seattle, Washington, 98101, United States
Vista Oncology

Olympia, Washington, 98502, United States

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