Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-03-09
572
Participants Needed
186
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent before any study procedures.
- At least 18 years old or legal age of consent in the study location.
- Histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of gastric, gastroesophageal junction, or distal esophagus.
- Positive CLDN18.2 expression from tumor samples collected within the past 24 months or from a fresh biopsy.
- Disease progression after at least one prior line of treatment for advanced or metastatic disease, including fluoropyrimidine and platinum.
- At least one measurable or evaluable lesion based on RECIST 1.1.
- ECOG performance status of 0 or 1 without deterioration in the previous 2 weeks before baseline or first dosing.
- Predicted life expectancy of at least 12 weeks.
- Adequate organ and bone marrow function.
- Body weight of at least 35 kg.
- Meet sex and contraceptive requirements as specified.
You will not qualify if you...
- Known HER2 positive status defined by IHC or ISH testing.
- Significant or unstable gastric bleeding or untreated gastric ulcers.
- Central nervous system metastases or serious CNS conditions including epilepsy, seizures, brain injury, dementia, Parkinson's disease, neurodegenerative diseases, or severe mental illness within 3 months prior to consent.
- Clinically significant corneal disease such as active keratitis or corneal ulcerations.
- Persistent toxicities from prior anticancer therapy graded 2 or higher, excluding hair loss, unless irreversible and stable.
- Previous treatment with any ADC containing MMAE or CLDN18.2-targeting therapies other than naked monoclonal antibodies.
- History of venous thromboembolism within 6 months before randomization (except stable cases) or arterial thromboembolism within 12 months before randomization.
- Any other disease or condition deemed by the investigator to make participation undesirable or unsafe.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 186 locations
1
Research Site
Birmingham, Alabama, United States, 35233
Withdrawn
2
Research Site
Mobile, Alabama, United States, 36604
Active, Not Recruiting
3
Research Site
Tucson, Arizona, United States, 85719
Active, Not Recruiting
4
Research Site
Duarte, California, United States, 91010
Active, Not Recruiting
5
Research Site
Fullerton, California, United States, 92835
Withdrawn
6
Research Site
Irvine, California, United States, 92618
Active, Not Recruiting
7
Research Site
Los Angeles, California, United States, 90048
Active, Not Recruiting
8
Research Site
Los Angeles, California, United States, 90089
Active, Not Recruiting
9
Research Site
Newport Beach, California, United States, 92663
Actively Recruiting
10
Research Site
Santa Rosa, California, United States, 95403
Withdrawn
11
Research Site
Washington D.C., District of Columbia, United States, 20007
Active, Not Recruiting
12
Research Site
Fleming Island, Florida, United States, 32003
Withdrawn
13
Research Site
Hollywood, Florida, United States, 33021
Active, Not Recruiting
14
Research Site
Orlando, Florida, United States, 32804
Active, Not Recruiting
15
Research Site
Atlanta, Georgia, United States, 30322
Withdrawn
16
Research Site
Marietta, Georgia, United States, 30060
Active, Not Recruiting
17
Research Site
Honolulu, Hawaii, United States, 96819
Withdrawn
18
Research Site
Boise, Idaho, United States, 83712
Active, Not Recruiting
19
Research Site
Lexington, Kentucky, United States, 40536
Active, Not Recruiting
20
Research Site
Baltimore, Maryland, United States, 21287
Withdrawn
21
Research Site
Boston, Massachusetts, United States, 02114
Active, Not Recruiting
22
Research Site
Ann Arbor, Michigan, United States, 48106
Active, Not Recruiting
23
Research Site
Ann Arbor, Michigan, United States, 48109
Active, Not Recruiting
24
Research Site
Kansas City, Missouri, United States, 64111
Active, Not Recruiting
25
Research Site
St Louis, Missouri, United States, 63110
Withdrawn
26
Research Site
St Louis, Missouri, United States, 63128
Withdrawn
27
Research Site
Mineola, New York, United States, 11501
Active, Not Recruiting
28
Research Site
New York, New York, United States, 10016
Active, Not Recruiting
29
Research Site
New York, New York, United States, 10032
Active, Not Recruiting
30
Research Site
New York, New York, United States, 10065
Actively Recruiting
31
Research Site
Cincinnati, Ohio, United States, 45219
Withdrawn
32
Research Site
Portland, Oregon, United States, 97239
Withdrawn
33
Research Site
Philadelphia, Pennsylvania, United States, 19111
Active, Not Recruiting
34
Research Site
York, Pennsylvania, United States, 17403
Active, Not Recruiting
35
Research Site
Charlottesville, Virginia, United States, 22908
Active, Not Recruiting
36
Research Site
Fredericksburg, Virginia, United States, 22408
Active, Not Recruiting
37
Research Site
Olympia, Washington, United States, 98502
Active, Not Recruiting
38
Research Site
Seattle, Washington, United States, 98109
Withdrawn
39
Research Site
Porto Alegre, Brazil, 91350-200
Actively Recruiting
40
Research Site
Ribeirão Preto, Brazil, 14051-140
Actively Recruiting
41
Research Site
São Paulo, Brazil, 05652-900
Actively Recruiting
42
Research Site
Vitória, Brazil, 29043-272
Actively Recruiting
43
Research Site
Calgary, Alberta, Canada, T2N 4N2
Withdrawn
44
Research Site
Barrie, Ontario, Canada, L4M 6M2
Actively Recruiting
45
Research Site
London, Ontario, Canada, N6C 2R5
Actively Recruiting
46
Research Site
North York, Ontario, Canada, M2K 1E1
Actively Recruiting
47
Research Site
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
48
Research Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
49
Research Site
Montreal, Quebec, Canada, H3G 1A4
Actively Recruiting
50
Research Site
Montreal, Quebec, Canada, H3T 1E2
Withdrawn
51
Research Site
Beijing, China, 100210
Actively Recruiting
52
Research Site
Changchun, China, 130021
Actively Recruiting
53
Research Site
Changsha, China, 410013
Withdrawn
54
Research Site
Chengdu, China, 610000
Actively Recruiting
55
Research Site
Chengdu, China, 610042
Actively Recruiting
56
Research Site
Fuzhou, China, 350001
Actively Recruiting
57
Research Site
Fuzhou, China, 350014
Actively Recruiting
58
Research Site
Guangzhou, China, 510060
Actively Recruiting
59
Research Site
Guangzhou, China, 510120
Actively Recruiting
60
Research Site
Guangzhou, China, 510655
Actively Recruiting
61
Research Site
Guangzhou, China, 510700
Actively Recruiting
62
Research Site
Hangzhou, China, 310020
Actively Recruiting
63
Research Site
Hangzhou, China, 310022
Actively Recruiting
64
Research Site
Harbin, China, 150049
Actively Recruiting
65
Research Site
Hefei, China, 230022
Actively Recruiting
66
Research Site
Hefei, China, 230031
Actively Recruiting
67
Research Site
Hefei, China, 230601
Actively Recruiting
68
Research Site
Jinan, China, 250117
Actively Recruiting
69
Research Site
Jining, China, 272029
Actively Recruiting
70
Research Site
Lanzhou, China, 730000
Actively Recruiting
71
Research Site
Lishui, China, 323000
Actively Recruiting
72
Research Site
Luoyang, China, 471003
Withdrawn
73
Research Site
Nanjing, China, 210008
Actively Recruiting
74
Research Site
Nanjing, China, 210009
Withdrawn
75
Research Site
Qingdao, China, 266003
Actively Recruiting
76
Research Site
Shanghai, China, 200025
Actively Recruiting
77
Research Site
Shanghai, China, 200032
Actively Recruiting
78
Research Site
Shanghai, China, 200040
Actively Recruiting
79
Research Site
Shenyang, China, 110042
Actively Recruiting
80
Research Site
Shijiazhuang, China, 050011
Actively Recruiting
81
Research Site
Suzhou, China, 215004
Actively Recruiting
82
Research Site
Tianjin, China, 300060
Actively Recruiting
83
Research Site
Ürümqi, China, 830000
Suspended
84
Research Site
Wuhan, China, 430000
Actively Recruiting
85
Research Site
Wuhan, China, 430030
Actively Recruiting
86
Research Site
Xi'an, China, 710061
Actively Recruiting
87
Research Site
Yinchuan, China, 750004
Actively Recruiting
88
Research Site
Zhengzhou, China, 450003
Actively Recruiting
89
Research Site
Besançon, France, 25030
Actively Recruiting
90
Research Site
Brest, France, 29200
Active, Not Recruiting
91
Research Site
Lille, France, 59037
Actively Recruiting
92
Research Site
Lyon, France, 69008
Active, Not Recruiting
93
Research Site
Nantes, France, 44000
Actively Recruiting
94
Research Site
Paris, France, 75571
Actively Recruiting
95
Research Site
Poitiers, France, 86021
Actively Recruiting
96
Research Site
Berlin, Germany, 10249
Actively Recruiting
97
Research Site
Berlin, Germany, 13353
Actively Recruiting
98
Research Site
Dresden, Germany, 01067
Withdrawn
99
Research Site
Dresden, Germany, 01370
Withdrawn
100
Research Site
Essen, Germany, 45136
Withdrawn
101
Research Site
Frankfurt, Germany, 60488
Actively Recruiting
102
Research Site
Göttingen, Germany, 37075
Actively Recruiting
103
Research Site
Hamburg, Germany, 20246
Actively Recruiting
104
Research Site
Heidelberg, Germany, 69120
Actively Recruiting
105
Research Site
Heilbronn, Germany, 74078
Actively Recruiting
106
Research Site
Leipzig, Germany, 04103
Actively Recruiting
107
Research Site
Mainz, Germany, 55131
Withdrawn
108
Research Site
Marburg, Germany, 35043
Actively Recruiting
109
Research Site
Moers, Germany, 47441
Actively Recruiting
110
Research Site
München, Germany, 81377
Actively Recruiting
111
Research Site
Hong Kong, Hong Kong, 150001
Actively Recruiting
112
Research Site
Hong Kong, Hong Kong
Actively Recruiting
113
Research Site
Ahmedabad, India, 380015
Actively Recruiting
114
Research Site
Bengaluru, India, 560027
Withdrawn
115
Research Site
Hyderabad, India, 500032
Actively Recruiting
116
Research Site
Mumbai, India, 400012
Actively Recruiting
117
Research Site
New Delhi, India, 110085
Actively Recruiting
118
Research Site
Florence, Italy, 50134
Actively Recruiting
119
Research Site
Milan, Italy, 20133
Actively Recruiting
120
Research Site
Milan, Italy, 20162
Actively Recruiting
121
Research Site
Modena, Italy, 41124
Withdrawn
122
Research Site
Naples, Italy, 80131
Actively Recruiting
123
Research Site
Padova, Italy, 35128
Actively Recruiting
124
Research Site
Pisa, Italy, 56100
Actively Recruiting
125
Research Site
Vicenza, Italy, 36100
Actively Recruiting
126
Research Site
Fukuoka, Japan, 812-8582
Actively Recruiting
127
Research Site
Kashiwa, Japan, 227-8577
Actively Recruiting
128
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
129
Research Site
Nagoya, Japan, 464-8681
Actively Recruiting
130
Research Site
Ogaki-shi, Japan, 503-8502
Actively Recruiting
131
Research Site
Osaka, Japan, 541-8567
Actively Recruiting
132
Research Site
Sunto-gun, Japan, 411-8777
Actively Recruiting
133
Research Site
Tokyo, Japan, 104-0045
Actively Recruiting
134
Research Site
Toyoake-shi, Japan, 470-1192
Actively Recruiting
135
Research Site
Yokohama, Japan, 241-8515
Actively Recruiting
136
Research Site
Bielsko-Biala, Poland, 43-300
Actively Recruiting
137
Research Site
Gdansk, Poland, 80-219
Actively Recruiting
138
Research Site
Katowice, Poland, 40-514
Active, Not Recruiting
139
Research Site
Krakow, Poland, 31-501
Actively Recruiting
140
Research Site
Lublin, Poland, 20-080
Actively Recruiting
141
Research Site
Szczecin, Poland, 71-730
Withdrawn
142
Research Site
Słupsk, Poland, 76-200
Active, Not Recruiting
143
Research Site
Tomaszów Mazowiecki, Poland, 97-200
Withdrawn
144
Research Site
Warsaw, Poland, 02-034
Actively Recruiting
145
Research Site
Warsaw, Poland, 04-141
Actively Recruiting
146
Research Site
Gyeonggi-do, South Korea, 13620
Actively Recruiting
147
Research Site
Seoul, South Korea, 03080
Actively Recruiting
148
Research Site
Seoul, South Korea, 03722
Actively Recruiting
149
Research Site
Seoul, South Korea, 05505
Active, Not Recruiting
150
Research Site
Seoul, South Korea, 06351
Actively Recruiting
151
Research Site
Seoul, South Korea, 06591
Actively Recruiting
152
Research Site
Barcelona, Spain, 08036
Actively Recruiting
153
Research Site
Barcelona, Spain, 8035
Actively Recruiting
154
Research Site
Madrid, Spain, 28034
Actively Recruiting
155
Research Site
Madrid, Spain, 28041
Actively Recruiting
156
Research Site
Ourense, Spain, 32005
Actively Recruiting
157
Research Site
Santander, Spain, 39008
Actively Recruiting
158
Research Site
Seville, Spain, 41013
Actively Recruiting
159
Research Site
Bern, Switzerland, 3010
Active, Not Recruiting
160
Research Site
Geneva, Switzerland, 1205
Active, Not Recruiting
161
Research Site
Lausanne, Switzerland, 1011
Active, Not Recruiting
162
Research Site
Zurich, Switzerland, 8032
Active, Not Recruiting
163
Research Site
Kaohsiung City, Taiwan, 00807
Actively Recruiting
164
Research Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
165
Research Site
Taichung, Taiwan, 40447
Actively Recruiting
166
Research Site
Tainan, Taiwan, 704
Actively Recruiting
167
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
168
Research Site
Taipei, Taiwan, 112
Actively Recruiting
169
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
170
Research Site
Bangkok, Thailand, 10700
Active, Not Recruiting
171
Research Site
Dusit, Thailand, 10300
Active, Not Recruiting
172
Research Site
Hat Yai, Thailand, 90110
Active, Not Recruiting
173
Research Site
Khon Kaen, Thailand, 40002
Active, Not Recruiting
174
Research Site
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
175
Research Site
Diyarbakır, Turkey (Türkiye), 21280
Actively Recruiting
176
Research Site
Erzurum, Turkey (Türkiye), 25240
Actively Recruiting
177
Research Site
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
178
Research Site
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
179
Research Site
London, United Kingdom, EC1A 7BE
Actively Recruiting
180
Research Site
London, United Kingdom, SW3 6JJ
Actively Recruiting
181
Research Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
182
Research Site
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
183
Research Site
Taunton, United Kingdom, TA1 5DA
Actively Recruiting
184
Research Site
Hanoi, Vietnam, 100000
Actively Recruiting
185
Research Site
Ho Chi Minh City, Vietnam, 700000
Actively Recruiting
186
Research Site
Vinh, Vietnam, 460000
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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