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AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
Sponsor: AstraZeneca
Summary
The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.
Official title: A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared With Investigator's Choice of Therapy in Second- or Later-Line Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (CLARITY Gastric 01)
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
572
Start Date
2024-03-04
Completion Date
2026-09-14
Last Updated
2026-03-09
Healthy Volunteers
No
Interventions
AZD0901
Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV
AZD0901
Participants in the AZD0901 arm 2 will receive dose level 2 AZD0901 IV (Enrolment was closed)
Ramucirumab+ paclitaxel
Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W
Paclitaxel
Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only)
Docetaxel
Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only)
Irinotecan
Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W
TAS-102
TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China)
Apatinib
Apatinib 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only)
Locations (186)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Tucson, Arizona, United States
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Duarte, California, United States
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Fullerton, California, United States
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Irvine, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Santa Rosa, California, United States
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Washington D.C., District of Columbia, United States
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Fleming Island, Florida, United States
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Hollywood, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Lexington, Kentucky, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Ann Arbor, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Mineola, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Cincinnati, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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York, Pennsylvania, United States
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Charlottesville, Virginia, United States
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Fredericksburg, Virginia, United States
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Olympia, Washington, United States
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Seattle, Washington, United States
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Porto Alegre, Brazil
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Ribeirão Preto, Brazil
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São Paulo, Brazil
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Vitória, Brazil
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Calgary, Alberta, Canada
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Barrie, Ontario, Canada
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London, Ontario, Canada
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North York, Ontario, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Chengdu, China
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Fuzhou, China
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Fuzhou, China
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Guangzhou, China
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Guangzhou, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Harbin, China
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Hefei, China
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Hefei, China
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Hefei, China
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Jinan, China
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Jining, China
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Lanzhou, China
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Lishui, China
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Luoyang, China
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Nanjing, China
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Nanjing, China
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Qingdao, China
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Shanghai, China
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Shanghai, China
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Shanghai, China
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Shenyang, China
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Shijiazhuang, China
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Suzhou, China
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Tianjin, China
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Ürümqi, China
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Wuhan, China
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Wuhan, China
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Xi'an, China
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Yinchuan, China
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Zhengzhou, China
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Besançon, France
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Lille, France
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Lyon, France
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Nantes, France
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Paris, France
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Poitiers, France
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Berlin, Germany
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Berlin, Germany
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Dresden, Germany
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Essen, Germany
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Frankfurt, Germany
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Göttingen, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Heilbronn, Germany
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Leipzig, Germany
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Mainz, Germany
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Marburg, Germany
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Moers, Germany
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München, Germany
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Ahmedabad, India
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Bengaluru, India
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Florence, Italy
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Padova, Italy
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Pisa, Italy
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Vicenza, Italy
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Fukuoka, Japan
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Kashiwa, Japan
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Kōtoku, Japan
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Nagoya, Japan
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Ogaki-shi, Japan
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Osaka, Japan
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Sunto-gun, Japan
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Tokyo, Japan
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Toyoake-shi, Japan
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Yokohama, Japan
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Bielsko-Biala, Poland
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Gdansk, Poland
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Katowice, Poland
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Krakow, Poland
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Lublin, Poland
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Szczecin, Poland
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Słupsk, Poland
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Tomaszów Mazowiecki, Poland
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Warsaw, Poland
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Warsaw, Poland
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Gyeonggi-do, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Madrid, Spain
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Ourense, Spain
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Seville, Spain
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Bern, Switzerland
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Geneva, Switzerland
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Lausanne, Switzerland
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Dusit, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Ankara, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Erzurum, Turkey (Türkiye)
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Hanoi, Vietnam
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Vinh, Vietnam