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)

Status: Recruiting
Location: See all (186) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
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• Capable of giving signed informed consent prior to any study procedure.

• Participant must be at least 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.

• Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement:

• (a) Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy.

• Disease progression on or after at least one prior line of treatment (LoT) for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.

• Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1.

• ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.

• Predicted life expectancy of ≥ 12 weeks.

• Adequate organ and bone marrow function

• Body weight of ≥ 35 kg.

⁃ Sex and Contraceptive Requirements

Locations
United States
Alabama
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Birmingham
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Mobile
Arizona
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Tucson
California
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Duarte
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Fullerton
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Irvine
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Los Angeles
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Los Angeles
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Newport Beach
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Santa Rosa
Washington, D.c.
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Washington D.c.
Florida
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Fleming Island
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Hollywood
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Orlando
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Idaho
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Lexington
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Kansas City
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St Louis
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New York
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Mineola
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Cincinnati
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Philadelphia
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York
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Olympia
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Other Locations
Brazil
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Ribeirão Preto
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Vitória
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Barrie
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Calgary
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London
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North York
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Ottawa
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Toronto
China
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Beijing
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Changchun
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Changsha
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Chengdu
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Chengdu
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Fuzhou
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Guangzhou
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Guangzhou
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Guangzhou
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Hangzhou
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Hangzhou
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Harbin
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Hefei
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Hefei
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Hefei
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Jinan
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Jining
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Lanzhou
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Lishui
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Luoyang
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Nanjing
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Nanjing
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Qingdao
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Shanghai
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Shanghai
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Shanghai
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Shenyang
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Shijiazhuang
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Suzhou
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Tianjin
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Wuhan
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Wuhan
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Xi'an
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Yinchuan
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Zhengzhou
France
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Besançon
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Brest
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Lille
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Lyon
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Nantes
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Paris
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Poitiers
Germany
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Berlin
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Berlin
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Dresden
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Dresden
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Essen
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Frankfurt
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Göttingen
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Hamburg
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Heidelberg
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Heilbronn
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Leipzig
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Mainz
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Marburg
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Moers
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München
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Hong Kong
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India
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Ahmedabad
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Florence
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Modena
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Padua
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Pisa
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Vicenza
Japan
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Fukuoka
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Osaka
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Yokohama
Poland
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Bielsko-biala
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Gdansk
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Katowice
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Krakow
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Lublin
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Słupsk
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Szczecin
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Tomaszów Mazowiecki
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Warsaw
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Warsaw
Republic of Korea
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Gyeonggi-do
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Seoul
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Seoul
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Seoul
Spain
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Barcelona
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Barcelona
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Madrid
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Madrid
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Ourense
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Santander
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Seville
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Bern
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Geneva
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Lausanne
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Zurich
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Kaohsiung City
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Taichung
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Tainan
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Taipei
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Taipei
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Taoyuan District
Thailand
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Bangkok
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Dusit
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Hat Yai
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Khon Kaen
Turkey
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Ankara
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Diyarbakır
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Erzurum
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Istanbul
United Kingdom
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Cambridge
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London
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London
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Manchester
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Oxford
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Taunton
Viet Nam
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Hanoi
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Ho Chi Minh City
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Vinh
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-03-04
Estimated Completion Date: 2026-09-14
Participants
Target number of participants: 572
Treatments
Experimental: AZD0901 arm 1
Participants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment.
Experimental: AZD0901 Arm 2
Participants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment. (Enrolment was closed)
Active_comparator: Investigator's choice arm
Participants in the Investigator's choice arm will receive a regimen of Investigator's choice, including regionally accepted chemotherapies or targeted therapies.
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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