Phase
Condition
Gastric Cancer
Stomach Cancer
Digestive System Neoplasms
Treatment
Ramucirumab+ paclitaxel
Irinotecan
Paclitaxel
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, aphasia, or strokewithin 3 months prior to consent, severe brain injury, dementia, Parkinson'sdisease, neurodegenerative diseases, cerebellar disease, severe uncontrolled mentalillness, 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).
Study Design
Study Description
Connect with a study center
Research Site
Porto Alegre, 91350-200
BrazilSite Not Available
Research Site
Ribeirao Preto, 14051-140
BrazilSite Not Available
Research Site
Sao Paulo, 05652-900
BrazilSite Not Available
Research Site
Vitória, 29043-272
BrazilSite Not Available
Research Site
Calgary, Alberta T2N 4N2
CanadaSite Not Available
Research Site
Barrie, Ontario L4M 6M2
CanadaActive - Recruiting
Research Site
London, Ontario N6C 2R5
CanadaActive - Recruiting
Research Site
North York, Ontario M2K 1E1
CanadaActive - Recruiting
Research Site
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
Research Site
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Research Site
Montreal, Quebec H3G 1A4
CanadaSite Not Available
Research Site
Beijing, 100210
ChinaActive - Recruiting
Research Site
Changchun, 130021
ChinaActive - Recruiting
Research Site
Changsha, 410013
ChinaActive - Recruiting
Research Site
Chengdu, 610000
ChinaActive - Recruiting
Research Site
Fuzhou, 350014
ChinaActive - Recruiting
Research Site
Fuzhou City, 350001
ChinaActive - Recruiting
Research Site
Guangzhou, 510120
ChinaActive - Recruiting
Research Site
Hangzhou, 310020
ChinaActive - Recruiting
Research Site
Harbin, 150049
ChinaActive - Recruiting
Research Site
Hefei, 230601
ChinaActive - Recruiting
Research Site
Jinan, 250117
ChinaActive - Recruiting
Research Site
Jining, 272029
ChinaActive - Recruiting
Research Site
Lanzhou, 730000
ChinaActive - Recruiting
Research Site
Lishui, 323000
ChinaActive - Recruiting
Research Site
Luoyang, 471003
ChinaSuspended
Research Site
Nanjing, 210009
ChinaSite Not Available
Research Site
Qingdao, 266003
ChinaActive - Recruiting
Research Site
Shanghai, 200040
ChinaActive - Recruiting
Research Site
Shenyang, 110042
ChinaActive - Recruiting
Research Site
Shijiazhuang, 050011
ChinaActive - Recruiting
Research Site
Suzhou, 215004
ChinaActive - Recruiting
Research Site
Tianjin, 300060
ChinaActive - Recruiting
Research Site
Urumqi, 830000
ChinaActive - Recruiting
Research Site
Wuhan, 430000
ChinaActive - Recruiting
Research Site
Xi'an, 710061
ChinaActive - Recruiting
Research Site
Yinchuan, 750004
ChinaActive - Recruiting
Research Site
Zhengzhou, 450003
ChinaActive - Recruiting
Research Site
Besançon Cedex, 25030
FranceActive - Recruiting
Research Site
Brest, 29200
FranceActive - Recruiting
Research Site
Lille, 59037
FranceActive - Recruiting
Research Site
Lyon, 69008
FranceActive - Recruiting
Research Site
Nantes, 44000
FranceActive - Recruiting
Research Site
PARIS Cedex 12, 75571
FranceActive - Recruiting
Research Site
Poitiers, 86021
FranceActive - Recruiting
Research Site
Berlin, 13353
GermanySite Not Available
Research Site
Dresden, 01067
GermanySite Not Available
Research Site
Essen, 45136
GermanySite Not Available
Research Site
Frankfurt, 60488
GermanyActive - Recruiting
Research Site
Göttingen, 37075
GermanyActive - Recruiting
Research Site
Hamburg, 20246
GermanySite Not Available
Research Site
Heidelberg, 69120
GermanySite Not Available
Research Site
Heilbronn, 74078
GermanyActive - Recruiting
Research Site
Leipzig, 04103
GermanyActive - Recruiting
Research Site
Mainz, 55131
GermanySite Not Available
Research Site
Marburg, 35043
GermanyActive - Recruiting
Research Site
Moers, 47441
GermanyActive - Recruiting
Research Site
München, 81377
GermanySite Not Available
Research Site
Hong Kong, 150001
Hong KongSite Not Available
Research Site
Ahmedabad, 380015
IndiaActive - Recruiting
Research Site
Bengaluru, 560027
IndiaSite Not Available
Research Site
Hyderabad, 500082
IndiaSite Not Available
Research Site
Mumbai, 400012
IndiaActive - Recruiting
Research Site
New Delhi, 110085
IndiaSite Not Available
Research Site
Florence, 50134
ItalyActive - Recruiting
Research Site
Milan, 20133
ItalyActive - Recruiting
Research Site
Milano, 20162
ItalyActive - Recruiting
Research Site
Modena, 41124
ItalySite Not Available
Research Site
Napoli, 80131
ItalySite Not Available
Research Site
Padova, 35128
ItalyActive - Recruiting
Research Site
Pisa, 56100
ItalyActive - Recruiting
Research Site
Vicenza, 36100
ItalyActive - Recruiting
Research Site
Fukuoka-shi, 812-8582
JapanActive - Recruiting
Research Site
Kashiwa, 227-8577
JapanActive - Recruiting
Research Site
Koto-ku, 135-8550
JapanActive - Recruiting
Research Site
Nagoya-shi, 464-8681
JapanActive - Recruiting
Research Site
Ogaki-shi, 503-8502
JapanActive - Recruiting
Research Site
Osaka-shi, 541-8567
JapanActive - Recruiting
Research Site
Sunto-gun, 411-8777
JapanActive - Recruiting
Research Site
Tokyo, 104-0045
JapanActive - Recruiting
Research Site
Toyoake-shi, 470-1192
JapanActive - Recruiting
Research Site
Yokohama-shi, 241-8515
JapanActive - Recruiting
Research Site
Gyeonggi-do, 13620
Korea, Republic ofActive - Recruiting
Research Site
Seoul, 03722
Korea, Republic ofActive - Recruiting
Research Site
Bielsko-Biała, 43-300
PolandSite Not Available
Research Site
Gdańsk, 80-219
PolandSite Not Available
Research Site
Katowice, 40-514
PolandActive - Recruiting
Research Site
Kraków, 31-501
PolandActive - Recruiting
Research Site
Lublin, 20-080
PolandSite Not Available
Research Site
Szczecin, 71-730
PolandSite Not Available
Research Site
Słupsk, 76-200
PolandSite Not Available
Research Site
Tomaszów Mazowiecki, 97-200
PolandSite Not Available
Research Site
Warszawa, 04-141
PolandActive - Recruiting
Research Site
Barcelona, 08036
SpainSite Not Available
Research Site
Madrid, 28041
SpainSite Not Available
Research Site
Orense, 32005
SpainSite Not Available
Research Site
Santander, 39008
SpainSite Not Available
Research Site
Sevilla, 41013
SpainSite Not Available
Research Site
Bern, 3010
SwitzerlandActive - Recruiting
Research Site
Genève 14, 1205
SwitzerlandActive - Recruiting
Research Site
Lausanne, 1011
SwitzerlandActive - Recruiting
Research Site
Zürich, 8032
SwitzerlandActive - Recruiting
Research Site
Kaohsiung, 83301
TaiwanActive - Recruiting
Research Site
Taichung, 40447
TaiwanActive - Recruiting
Research Site
Tainan,
TaiwanActive - Recruiting
Research Site
Taipei, 112
TaiwanActive - Recruiting
Research Site
Taoyuan, 333
TaiwanActive - Recruiting
Research Site
Bangkok, 10700
ThailandActive - Recruiting
Research Site
Dusit, 10300
ThailandActive - Recruiting
Research Site
Hat Yai, 90110
ThailandActive - Recruiting
Research Site
Khon-Kaen, 40002
ThailandActive - Recruiting
Research Site
Ankara, 06230
TurkeySite Not Available
Research Site
Diyarbakir, 21280
TurkeySite Not Available
Research Site
Erzurum, 25240
TurkeyActive - Recruiting
Research Site
Istanbul, 34098
TurkeyActive - Recruiting
Research Site
Cambridge, CB2 0QQ
United KingdomSite Not Available
Research Site
London, EC1A 7BE
United KingdomSite Not Available
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
Birmingham, Alabama 35233
United StatesSite Not Available
Research Site
Mobile, Alabama 36604
United StatesActive - Recruiting
Research Site
Tucson, Arizona 85719
United StatesActive - Recruiting
Research Site
Duarte, California 91010
United StatesActive - Recruiting
Research Site
Fullerton, California 92835
United StatesActive - Recruiting
Research Site
Irvine, California 92618
United StatesActive - Recruiting
Research Site
Los Angeles, California 90089
United StatesActive - Recruiting
Research Site
Newport Beach, California 92663
United StatesActive - Recruiting
Research Site
Santa Rosa, California 95403
United StatesSite Not Available
Research Site
Washington, District of Columbia 20007
United StatesActive - Recruiting
Research Site
Hollywood, Florida 33021
United StatesActive - Recruiting
Research Site
Orlando, Florida 32803
United StatesActive - Recruiting
Research Site
Atlanta, Georgia 30322
United StatesActive - Recruiting
Research Site
Marietta, Georgia 30060
United StatesActive - Recruiting
Research Site
Honolulu, Hawaii 96819
United StatesActive - Recruiting
Research Site
Boise, Idaho 83712
United StatesActive - Recruiting
Research Site
Lexington, Kentucky 40536
United StatesActive - Recruiting
Research Site
Baltimore, Maryland 21287
United StatesSite Not Available
Research Site
Boston, Massachusetts 02114
United StatesActive - Recruiting
Research Site
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Research Site
Kansas City, Missouri 64111
United StatesActive - Recruiting
Research Site
Saint Louis, Missouri 63128
United StatesActive - Recruiting
Research Site
Mineola, New York 11501
United StatesActive - Recruiting
Research Site
New York, New York 10032
United StatesActive - Recruiting
Research Site
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Research Site
Portland, Oregon 97239
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19111
United StatesActive - Recruiting
Research Site
Charlottesville, Virginia 22908
United StatesActive - Recruiting
Research Site
Fredericksburg, Virginia 22408
United StatesActive - Recruiting
Research Site
Olympia, Washington 98502
United StatesActive - Recruiting
Research Site
Seattle, Washington 98109
United StatesSite Not Available
Research Site
Hanoi, 100000
VietnamActive - Recruiting
Research Site
Ho Chi Minh, 700000
VietnamActive - Recruiting
Research Site
Ho Chi Minh city, 700000
VietnamSite Not Available
Research Site
Vinh, 460000
VietnamActive - Recruiting
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