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NCT07044336PHASE3Recruiting

Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)

AstraZeneca

Start Date

8/1/2025

Completion Date

7/17/2029

Summary

This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based chemotherapy and anti-PD-1/anti-PD-L1 therapy.

Detailed Description

The target population of interest in this study is participants with B7-H4-selected advanced/metastatic EC who have progressed on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 therapy, either separately or in combination and should have received no more than 2 prior lines of therapy in advanced/metastatic setting. Participants will be randomized in a 1:1 ratio to Puxi-Sam (arm A) or physician's choice of chemotherapy (arm B; doxorubicin or paclitaxel). The total study size will be approximately 700 eligible participants. During the treatment period, participants will receive Puxi-Sam IV Day 1 Q3W (Arm A) or either doxorubicin treatment IV Day 1 Q3W or paclitaxel treatment IV on Days 1, 8, and 15 in 28-day cycle (Arm B). This study aims to see if Puxi-Sam allows participants to live longer without their endometrial cancer getting worse, or simply to live longer, compared to participants receiving standard of care chemotherapy. This study is also looking to see how the treatment and the endometrial cancer affects participants' quality of life.

Eligibility Criteria

Age Range: 18 years to No maximum

The main inclusion criteria include but are not limited to the following: * Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma. * Recurrent/metastatic EC ie, with radiological or objective evidence of recurrence or progression. * Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination. * A WHO/ECOG performance status of 0 or 1 at Screening. * Has radiographically measurable disease by RECIST 1.1 The main exclusion criteria include but are not limited to the following: * Had uterine sarcomas or uterine neuroendocrine carcinoma. * Has had a recurrence of endometrial carcinoma or carcinosarcoma more than \> 12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. * Had previously received treatment with any therapy (approved or investigational) that contained a TOP1i including ADCs . * Had previously received treatment with Puxi-Sam or another B7-H4 targeting agent. * History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses. * Active or previously documented autoimmune or inflammatory disorders

Interventions

DRUG

Puxitatug Samrotecan

DRUG

Doxorubicin

DRUG

Paclitaxel

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Conditions

Endometrial CancerMalignant Solid Tumour

Locations

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Tucson, Arizona 85719

United States

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La Jolla, California 92037

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Los Angeles, California 90095

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Orange, California 92868

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Washington D.C., District of Columbia 20016

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Jupiter, Florida 33458

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Miami, Florida 33136

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Miami, Florida 33176

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Miami Beach, Florida 33140

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New Port Richey, Florida 34655

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Orlando, Florida 32806

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Tampa, Florida 33612

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West Palm Beach, Florida 33401

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Honolulu, Hawaii 96826

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Chicago, Illinois 60607

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Peoria, Illinois 61637

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Urbana, Illinois 61801

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Fort Wayne, Indiana 46845

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Indianapolis, Indiana 46260

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Scarborough, Maine 04074

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Baltimore, Maryland 21201

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Baltimore, Maryland 21231

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Silver Spring, Maryland 20910

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Ann Arbor, Michigan 48109

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Ann Arbor, Michigan 48197

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Detroit, Michigan 48201

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Minneapolis, Minnesota 55404

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Camden, New Jersey 08103

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Paramus, New Jersey 07652

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Albuquerque, New Mexico 87109

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Brooklyn, New York 11220

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Stony Brook, New York 11794

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The Bronx, New York 10461

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White Plains, New York 10601

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Greenville, North Carolina 27834

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Pinehurst, North Carolina 28374

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Cincinnati, Ohio 45220

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Cleveland, Ohio 44106

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Cleveland, Ohio 44109

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Columbus, Ohio 43219

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Dayton, Ohio 45459

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Hilliard, Ohio 43026

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Sylvania, Ohio 43560

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Eugene, Oregon 97401

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Portland, Oregon 97239

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Bethlehem, Pennsylvania 18015

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Hershey, Pennsylvania 17033

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Lancaster, Pennsylvania 17601

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Philadelphia, Pennsylvania 19107

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Pittsburgh, Pennsylvania 15213

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Pittsburgh, Pennsylvania 15224

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Willow Grove, Pennsylvania 19090

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York, Pennsylvania 17403

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Sioux Falls, South Dakota 57104

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Sioux Falls, South Dakota 57105

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Knoxville, Tennessee 37920

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Nashville, Tennessee 37232

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Austin, Texas 78758

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Houston, Texas 77030

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Tyler, Texas 75702

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Fairfax, Virginia 22031

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Falls Church, Virginia 22042

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Norfolk, Virginia 23502

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Richmond, Virginia 23298

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Roanoke, Virginia 24016

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Kennewick, Washington 99336

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Seattle, Washington 98104

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Morgantown, West Virginia 26505

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Waukesha, Wisconsin 53188

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Capital Federal, C1417DTB

Argentina

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Ciudad Autonoma Buenos Aires, 1405

Argentina

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Ciudad de Buenos Aires, C1118AAT

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Córdoba, 2356

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Córdoba, X5004FHP

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Cuidad Autónoma de Buenos Aire, C1426ANZ

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La Rioja, 5300

Argentina

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Pergamino, B2700CPM

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Viedma, R8500ACE

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Malvern, 3144

Australia

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Melbourne, 3000

Australia

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Randwick, 2031

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St Leonards, 2065

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Subiaco, 6008

Australia

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Westmead, 2145

Australia

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Graz, 8036

Austria

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Innsbruck, 6020

Austria

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Vienna, 1090

Austria

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Brussels, 1070

Belgium

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Brussels, 1200

Belgium

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Charleroi, 6000

Belgium

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Edegem, 2650

Belgium

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Ghent, 9000

Belgium

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Leuven, 3000

Belgium

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Liège, 4000

Belgium

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Liège, 4000

Belgium

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Namur, 5000

Belgium

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Belém, 66073-005

Brazil

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Belo Horizonte, 30360-680

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Bento Gonçalves, 95700-084

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Blumenau, 89010-340

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Curitiba, 80510-130

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Curitiba, 80810-050

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Florianópolis, 88020-210

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Joinville, 89201-260

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Natal, 59062-000

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Porto Alegre, 90020-090

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Porto Alegre, 90470-340

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Porto Alegre, 90610-001

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Recife, 50040-000

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Recife, 50070-480

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Recife, 52010-075

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Ribeirão Preto, 14026-040

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Rio de Janeiro, 22281-100

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Rio de Janeiro, 22775-001

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Salvador, 41950-640

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São Caetano do Sul, 09541-270

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São Paulo, 01317-000

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São Paulo, 01323-000

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São Paulo, 01323-020

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São Paulo, 01509-900

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Sorocaba, 18030-005

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Sorocaba, 18052-210

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Taubaté, 12030-200

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Teresina, 64049-200

Brazil

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Edmonton, Alberta T6G 1Z2

Canada

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Winnipeg, Manitoba R3A 1R9

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Hamilton, Ontario L8V 5C2

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Kingston, Ontario K7L 2V7

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Montreal, Quebec H2X 0C1

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Montreal, Quebec H3T 1E2

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Beijing, 100021

China

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Beijing, 100026

China

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Beijing, 100044

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Beijing, 100730

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Changchun, 130021

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Changsha, 410011

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Changsha, 410013

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Chengdu, 610041

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Chongqing, 400030

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Dalian, 116023

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Fuzhou, 350014

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Guangzhou, 510120

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Hangzhou, 310006

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Hangzhou, 310022

China

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Jinan, 250012

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Jinan, 250117

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Nanchang, 330006

China

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Nanjing, 210004

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Shanghai, 200011

China

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Shanghai, 200025

China

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Shanghai, 200072

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Shenyang, 110004

China

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Shenyang, 110042

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Shenzhen, 518116

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Shijiazhuang, 050011

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Tianjin, 300060

China

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Tianjin, 300110

China

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Wenzhou, 325000

China

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Wuhan, 430022

China

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Wuhan, 430030

China

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Xi'an, 710061

China

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Zhanjiang, 524001

China

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Zhengzhou, 450002

China

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Brno, 625 00

Czechia

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Brno, 656 53

Czechia

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Hradec Králové, 500 05

Czechia

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Nový Jičín, 74101

Czechia

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Ostrava, 708 502

Czechia

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Prague, 12808

Czechia

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Prague, 180 81

Czechia

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V Uvalu 84, 150 06

Czechia

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Herlev, 2730

Denmark

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Odense, 5000

Denmark

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Kuopio, 70210

Finland

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Tampere, 33520

Finland

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Turku, 20520

Finland

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Avignon, 84918

France

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Besançon, 25000

France

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Bordeaux, 33076

France

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Chambray-lès-Tours, 37170

France

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Cholet, 49300

France

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Créteil, 94010

France

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Grenoble, 38000

France

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Lille, 59000

France

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Limoges, 87042

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Lyon, 69008

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Nantes, 44000

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Nîmes, 30029

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Paris, 75014

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Paris, 75020

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Paris, 75900

France

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Plerin SUR MER, 22190

France

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Rennes, 35000

France

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Toulouse, 31059

France

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Batumi, 6000

Georgia

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Tbilisi, 0159

Georgia

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Tbilisi, 0186

Georgia

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Amberg, 92224

Germany

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Chemnitz, 09116

Germany

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Dresden, 01307

Germany

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Essen, 45130

Germany

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Frankfurt am Main, 60596

Germany

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Freiburg im Breisgau, 79106

Germany

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Hamburg, 20246

Germany

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Heidelberg, 69120

Germany

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Heilbronn, 74078

Germany

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Kassel, 34125

Germany

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Mainz, 55131

Germany

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Münster, 48149

Germany

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Paderborn, 33161

Germany

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Regensburg, 93053

Germany

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Schwäbisch Hall, 74523

Germany

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Ulm, 89075

Germany

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Witten, 58452

Germany

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Athens, 115 28

Greece

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Athens, 11528

Greece

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Athens, 14564

Greece

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Thessaloniki, 55236

Greece

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Budapest, 1082

Hungary

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Budapest, 1122

Hungary

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Debrecen, 4032

Hungary

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Győr, 9024

Hungary

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Ashdod, 7747629

Israel

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Hadera, 38100

Israel

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Haifa, 3109601

Israel

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Holon, 5822012

Israel

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Jerusalem, 9103102

Israel

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Jerusalem, 9112001

Israel

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Nahariya, 2210001

Israel

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Ramat Gan, 5262000

Israel

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Safed, 13100

Israel

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Tel Aviv, 6423906

Israel

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Alessandria, 15121

Italy

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Aviano, 33081

Italy

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Bari, 70124

Italy

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Bologna, 40138

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Catania, 95126

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Florence, 50134

Italy

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Haifa, 34362

Italy

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Milan, 20132

Italy

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Milan, 20141

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Milan, 20159

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Milan, 20162

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Monza, 20900

Italy

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Naples, 80131

Italy

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Padova, 35128

Italy

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Parma, 43126

Italy

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Pisa, 56100

Italy

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Ponderano, 13875

Italy

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Roma, 00168

Italy

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Torino, 10128

Italy

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Vicenza, 36100

Italy

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Chūōku, 104-0045

Japan

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Hidaka-shi, 350-1298

Japan

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Isehara-shi, 259-1193

Japan

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Kashiwa-shi, 277-8567

Japan

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Kōtoku, 135-8550

Japan

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Kurume-shi, 830-0011

Japan

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Matsuyama, 791-0280

Japan

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Minatoku, 105-8471

Japan

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Nagoya, 464-8681

Japan

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Nakagami-gun, 903-0215

Japan

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Niigata, 951-8510

Japan

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Okayama, 700-8558

Japan

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Osaka, 637086

Japan

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Sapporo, 003-0804

Japan

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Sapporo, 060-8638

Japan

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Sendai, 980-8574

Japan

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Suita, 565-0871

Japan

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Sunto-gun, 411-8777

Japan

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Toon-Shi, 791-0295

Japan

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Tsu, 514-8507

Japan

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Yokohama, 236-0004

Japan

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Kaunas, LT50009

Lithuania

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Vilnius, 08661

Lithuania

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Vilnius, 8660

Lithuania

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Amsterdam, 1081 HV

Netherlands

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Maastricht, 6202 AZ

Netherlands

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Lodz, 93-338

Poland

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Siedlce, 08-110

Poland

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Singapore, 119228

Singapore

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Singapore, 168583

Singapore

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Singapore, 217562

Singapore

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Ljubljana, 1000

Slovenia

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Maribor, 2000

Slovenia

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Goyang-si, 410-769

South Korea

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Gwangjin-gu, 110-744

South Korea

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Seoul, 03722

South Korea

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Seoul, 06273

South Korea

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Seoul, 135-710

South Korea

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Songpa-gu, 05505

South Korea

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Suwon, 16499

South Korea

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Badalona, 8916

Spain

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Barcelona, 8025

Spain

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Barcelona, 8035

Spain

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Córdoba, 14004

Spain

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El Palmar (Murcia), 30120

Spain

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L'Hospitalet de Llobregat, 8908

Spain

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Madrid, 28033

Spain

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Madrid, 28041

Spain

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Málaga, 29010

Spain

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Oviedo, 33011

Spain

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Santiago de Compostela, 15706

Spain

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Seville, 41013

Spain

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Seville, 41014

Spain

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Valencia, 46010

Spain

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New Taipei City, 220

Taiwan

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Taichung, 40705

Taiwan

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Tainan, 70403

Taiwan

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Taipei, 100

Taiwan

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Taipei, 10449

Taiwan

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Bebington, CH63 4JY

United Kingdom

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Canterbury, CT1 3NG

United Kingdom

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Derby, DE22 3NE

United Kingdom

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London, E1 1BB

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London, SE1 7EH

United Kingdom

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London, W2 1NY

United Kingdom

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Manchester, M20 4BX

United Kingdom

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Northwood, HA6 2RN

United Kingdom

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Truro, TR1 3LJ

United Kingdom