Phase
Condition
Stomach Cancer
Gastric Cancer
Adenocarcinoma
Treatment
Ramucirumab+ paclitaxel
Irinotecan
AZD0901
Clinical Study ID
Ages 18-130 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 thejurisdiction in which the study is taking place at the time of signing the ICF.
Histologically confirmed unresectable, locally advanced or metastatic adenocarcinomaof gastric, GEJ, or distal esophagus (distal third of the esophagus) and thefollowing requirement:
(a) Participants with positive CLDN18.2 expression from archival tumor collectedwithin past 24 months or from a fresh biopsy.
Disease progression on or after at least one prior line of treatment (LoT) foradvanced 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 Investigatorbased on RECIST 1.1.
ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeksprior 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
Exclusion
Exclusion Criteria:
Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals/cellare considered positive by ISH). Participants must undergo local (or have had) HER2testing by IHC/ISH, and the most recent result of HER2 status will be used todetermine the eligibility.
Participant has significant or unstable gastric bleeding and/or untreated gastriculcers.
CNS metastases or CNS pathology including: epilepsy, seizures or aphasia within 3months prior to consent, severe brain injury, dementia, Parkinson's disease,neurodegenerative diseases, cerebellar disease, severe uncontrolled mental illness,psychosis, CNS involvement of autoimmune diseases.
Participant has known clinically significant corneal disease (eg, active keratitisor corneal ulcerations).
Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy,excluding alopecia. Participants with irreversible toxicity that is not reasonablyexpected to be exacerbated by study intervention may be included (eg, hearing loss).
Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatmentother than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy,multi-specific antibody including targeting CLDN18.2, etc).
History of thromboembolic events:
Participants with venous thromboembolism within the past 6 months prior torandomization: participants with venous port or catheter thrombosis orsuperficial venous thrombus that do not require treatment or are stable ontreatment with anticoagulants are excepted
History of arterial thromboembolism within the past 12 months prior torandomization
As judged by the Investigator, any evidence of diseases which in the Investigator'sopinion, makes it undesirable for the participant to participate in the study orthat would jeopardize compliance with the protocol.
Study Design
Study Description
Connect with a study center
Research Site
Ribeirão Preto, 14051-140
BrazilSite Not Available
Research Site
São Paulo, 05652-900
BrazilSite Not Available
Research Site
Vitória, 29043-272
BrazilSite Not Available
Research Site
Barrie, Ontario L4M 6M2
CanadaSite Not Available
Research Site
London, Ontario N6C 2R5
CanadaSite Not Available
Research Site
North York, Ontario M2K 1E1
CanadaSite Not Available
Research Site
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Research Site
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Research Site
Montreal, Quebec H3G 1A4
CanadaSite Not Available
Research Site
Montreal 6077243, Quebec 6115047 H3T 1E2
CanadaSite Not Available
Research Site
Beijing, 100210
ChinaSite Not Available
Research Site
Changchun, 130021
ChinaSite Not Available
Research Site
Chengdu, 610000
ChinaSite Not Available
Research Site
Chengdu 1815286, 610042
ChinaActive - Recruiting
Research Site
Fuzhou, 350001
ChinaSite Not Available
Research Site
Fuzhou 1810821, 350014
ChinaActive - Recruiting
Research Site
Guangzhou, 510655
ChinaSite Not Available
Research Site
Guangzhou 1809858, 510120
ChinaActive - Recruiting
Research Site
Hangzhou, 310022
ChinaSite Not Available
Research Site
Hangzhou 1808926, 310022
ChinaActive - Recruiting
Research Site
Harbin, 150049
ChinaSite Not Available
Research Site
Hefei, 230022
ChinaSite Not Available
Research Site
Hefei 1808722, 230022
ChinaActive - Recruiting
Research Site
Jinan, 250117
ChinaSite Not Available
Research Site
Jining, 272029
ChinaSite Not Available
Research Site
Lanzhou, 730000
ChinaSite Not Available
Research Site
Lishui, 323000
ChinaSite Not Available
Research Site
Nanjing, 210008
ChinaSite Not Available
Research Site
Nanjing 1799962, 210009
ChinaSite Not Available
Research Site
Qingdao, 266034
ChinaSite Not Available
Research Site
Shanghai, 200025
ChinaSite Not Available
Research Site
Shanghai 1796236, 200032
ChinaActive - Recruiting
Research Site
Shenyang, 110042
ChinaSite Not Available
Research Site
Shijiazhuang, 050011
ChinaSite Not Available
Research Site
Suzhou, 215004
ChinaSite Not Available
Research Site
Tianjin, 300060
ChinaSite Not Available
Research Site
Wuhan, 430030
ChinaSite Not Available
Research Site
Wuhan 1791247, 430030
ChinaActive - Recruiting
Research Site
Xi'an, 710061
ChinaSite Not Available
Research Site
Yinchuan, 750004
ChinaSite Not Available
Research Site
Zhengzhou, 450003
ChinaSite Not Available
Research Site
Ürümqi, 830000
ChinaSite Not Available
Research Site
Besançon, 25030
FranceSite Not Available
Research Site
Brest, 29200
FranceSite Not Available
Research Site
Lille, 59037
FranceSite Not Available
Research Site
Lyon, 69008
FranceSite Not Available
Research Site
Nantes, 44000
FranceSite Not Available
Research Site
Berlin, 13353
GermanySite Not Available
Research Site
Berlin 2950159, 10249
GermanyActive - Recruiting
Research Site
Dresden, 01067
GermanySite Not Available
Research Site
Dresden 2935022, 01370
GermanySite Not Available
Research Site
Essen, 45130
GermanySite Not Available
Research Site
Frankfurt, 60488
GermanySite Not Available
Research Site
Göttingen, 37075
GermanySite Not Available
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Hamburg, 20246
GermanySite Not Available
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Heidelberg, 69120
GermanySite Not Available
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Heilbronn, 74078
GermanySite Not Available
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Leipzig, 04103
GermanySite Not Available
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Marburg, 35043
GermanySite Not Available
Research Site
Moers, 47441
GermanySite Not Available
Research Site
München, 81377
GermanySite Not Available
Research Site
Hong Kong, 150001
Hong KongSite Not Available
Research Site
Hong Kong 1819729,
Hong KongActive - Recruiting
Research Site
Ahmedabad, 380015
IndiaSite Not Available
Research Site
Hyderabad, 500032
IndiaSite Not Available
Research Site
Mumbai, 400012
IndiaSite Not Available
Research Site
New Delhi, 110085
IndiaSite Not Available
Research Site
Florence, 50134
ItalySite Not Available
Research Site
Milan, 20133
ItalySite Not Available
Research Site
Milan 6951411, 20162
ItalyActive - Recruiting
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Naples, 80131
ItalySite Not Available
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Padova, 35128
ItalySite Not Available
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Pisa, 56100
ItalySite Not Available
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Vicenza, 36100
ItalySite Not Available
Research Site
Fukuoka, 812-8582
JapanSite Not Available
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Kashiwa, 227-8577
JapanSite Not Available
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Kōtoku, 135-8550
JapanSite Not Available
Research Site
Nagoya, 464-8681
JapanSite Not Available
Research Site
Ogaki-shi, 503-8502
JapanSite Not Available
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Osaka, 541-8567
JapanSite Not Available
Research Site
Sunto-gun, 411-8777
JapanSite Not Available
Research Site
Tokyo, 104-0045
JapanSite Not Available
Research Site
Toyoake-shi, 470-1192
JapanSite Not Available
Research Site
Yokohama, 241-8515
JapanSite Not Available
Research Site
Seoul, 06351
Korea, Republic ofActive - Recruiting
Research Site
Bielsko-Biala, 43-300
PolandSite Not Available
Research Site
Gdansk, 80-219
PolandSite Not Available
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Katowice, 40-514
PolandSite Not Available
Research Site
Krakow, 31-501
PolandSite Not Available
Research Site
Lublin, 20-080
PolandSite Not Available
Research Site
Słupsk, 76-200
PolandSite Not Available
Research Site
Warsaw, 02-034
PolandSite Not Available
Research Site
Warsaw 756135, 04-141
PolandActive - Recruiting
Research Site
Warszawa, 02-034
PolandActive - Recruiting
Research Site
Gyeonggi-do, 13620
South KoreaSite Not Available
Research Site
Seoul, 03722
South KoreaSite Not Available
Research Site
Seoul 1835848, 03080
South KoreaActive - Recruiting
Research Site
Barcelona, 08036
SpainSite Not Available
Research Site
Barcelona 3128760, 8035
SpainActive - Recruiting
Research Site
Madrid, 28034
SpainSite Not Available
Research Site
Madrid 3117735, 28034
SpainActive - Recruiting
Research Site
Ourense, 32005
SpainSite Not Available
Research Site
Santander, 39008
SpainSite Not Available
Research Site
Sevilla,
SpainSite Not Available
Research Site
Seville, 41013
SpainSite Not Available
Research Site
Bern, 3010
SwitzerlandSite Not Available
Research Site
Geneva, 1205
SwitzerlandSite Not Available
Research Site
Lausanne, 1011
SwitzerlandSite Not Available
Research Site
Zurich, 8032
SwitzerlandSite Not Available
Research Site
Kaohsiung, 00807
TaiwanActive - Recruiting
Research Site
Kaohsiung City, 00807
TaiwanSite Not Available
Research Site
Kaohsiung City 1673820, 83301
TaiwanActive - Recruiting
Research Site
Taichung, 40447
TaiwanSite Not Available
Research Site
Tainan, 704
TaiwanSite Not Available
Research Site
Tainan 1668355,
TaiwanActive - Recruiting
Research Site
Taipei, 112
TaiwanSite Not Available
Research Site
Taipei 1668341, 112
TaiwanActive - Recruiting
Research Site
Taoyuan, 333
TaiwanSite Not Available
Research Site
Bangkok, 10700
ThailandSite Not Available
Research Site
Dusit, 10300
ThailandSite Not Available
Research Site
Hat Yai, 90110
ThailandSite Not Available
Research Site
Khon Kaen, 40002
ThailandSite Not Available
Research Site
Ankara, 06230
Turkey (Türkiye)Site Not Available
Research Site
Diyarbakır, 21280
Turkey (Türkiye)Site Not Available
Research Site
Erzurum, 25240
Turkey (Türkiye)Site Not Available
Research Site
Istanbul, 34098
Turkey (Türkiye)Site Not Available
Research Site
Cambridge, CB2 0QQ
United KingdomSite Not Available
Research Site
London, SW3 6JJ
United KingdomSite Not Available
Research Site
London 2643743, EC1A 7BE
United KingdomActive - Recruiting
Research Site
Manchester, M20 4BX
United KingdomSite Not Available
Research Site
Oxford, OX3 7LE
United KingdomSite Not Available
Research Site
Taunton, TA1 5DA
United KingdomSite Not Available
Research Site
Mobile, Alabama 36604
United StatesSite Not Available
Research Site
Tucson, Arizona 85719
United StatesSite Not Available
Research Site
Duarte, California 91010
United StatesSite Not Available
Research Site
Irvine, California 92618
United StatesSite Not Available
Research Site
Los Angeles, California 90089
United StatesSite Not Available
Research Site
Newport Beach, California 92663
United StatesSite Not Available
Research Site
Los Angeles 5368361, California 5332921 90089
United StatesActive - Recruiting
Research Site
Washington D.C., District of Columbia 20007
United StatesSite Not Available
Research Site
Hollywood, Florida 33021
United StatesSite Not Available
Research Site
Orlando, Florida 32804
United StatesSite Not Available
Research Site
Marietta, Georgia 30060
United StatesSite Not Available
Research Site
Boise, Idaho 83712
United StatesSite Not Available
Research Site
Lexington, Kentucky 40536
United StatesSite Not Available
Research Site
Boston, Massachusetts 02114
United StatesSite Not Available
Research Site
Ann Arbor, Michigan 48109
United StatesSite Not Available
Research Site
Ann Arbor 4984247, Michigan 5001836 48109
United StatesActive - Recruiting
Research Site
Kansas City, Missouri 64111
United StatesSite Not Available
Research Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Research Site
St Louis, Missouri 63128
United StatesSite Not Available
Research Site
St Louis 4407066, Missouri 4398678 63128
United StatesSite Not Available
Research Site
Mineola, New York 11501
United StatesSite Not Available
Research Site
New York, New York 10032
United StatesSite Not Available
Research Site
New York 5128581, New York 5128638 10016
United StatesActive - Recruiting
Research Site
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Research Site
York, Pennsylvania 17403
United StatesSite Not Available
Research Site
Charlottesville, Virginia 22908
United StatesSite Not Available
Research Site
Fredericksburg, Virginia 22408
United StatesSite Not Available
Research Site
Olympia, Washington 98502
United StatesSite Not Available
Research Site
Hanoi, 100000
VietnamSite Not Available
Research Site
Ho Chi Minh City, 700000
VietnamSite Not Available
Research Site
Vinh, 460000
VietnamSite Not Available

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