Actively Recruiting
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
Led by AstraZeneca · Updated on 2026-04-13
2130
Participants Needed
258
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
CONDITIONS
Official Title
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Capable of giving signed informed consent
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Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
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Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma
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Positive CLDN18.2 expression, as determined prospectively by central IHC testing
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Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below:
- Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.
- Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible
-
ECOG performance status of 0 or 1 with no deterioration to > 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation.
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Minimum life expectancy of ≥ 12 weeks.
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At least one lesion (measurable and/or non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1.
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Adequate organ and bone marrow function as specified in the protocol
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Body weight ≥ 35 kg.
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Sex and contraceptive requirements
You will not qualify if you...
- Known HER2-positive status
- Significant or unstable gastric bleeding and/or untreated gastric ulcers.
- Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.
- CNS pathology
- Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter/drain.
- Require parenteral nutrition support due to gastric or gastrointestinal obstruction.
- Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening.
- Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
- Cardiac abnormalities as outlined in the protocol
- Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation.
- Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and/or chronic or active hepatitis B with HBV DNA ≥ 100 IU/mL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled
- Known partial or total DPD enzyme deficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 258 locations
1
Research Site
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
2
Research Site
Springdale, Arkansas, United States, 72762
Not Yet Recruiting
3
Research Site
Duarte, California, United States, 91010
Not Yet Recruiting
4
Research Site
La Jolla, California, United States, 92093
Not Yet Recruiting
5
Research Site
Los Alamitos, California, United States, 90720
Not Yet Recruiting
6
Research Site
Orange, California, United States, 92868
Not Yet Recruiting
7
Research Site
Walnut Creek, California, United States, 94598
Not Yet Recruiting
8
Research Site
Denver, Colorado, United States, 80210
Not Yet Recruiting
9
Research Site
Lone Tree, Colorado, United States, 80124
Not Yet Recruiting
10
Research Site
New Haven, Connecticut, United States, 06510
Withdrawn
11
Research Site
Newark, Delaware, United States, 19713
Not Yet Recruiting
12
Research Site
Washington D.C., District of Columbia, United States, 20007
Withdrawn
13
Research Site
Fort Myers, Florida, United States, 33901
Withdrawn
14
Research Site
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
15
Research Site
St. Petersburg, Florida, United States, 33705
Withdrawn
16
Research Site
West Palm Beach, Florida, United States, 33401
Withdrawn
17
Research Site
Atlanta, Georgia, United States, 30309
Not Yet Recruiting
18
Research Site
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
19
Research Site
Atlanta, Georgia, United States, 30342
Withdrawn
20
Research Site
Macon, Georgia, United States, 31201
Not Yet Recruiting
21
Research Site
Newnan, Georgia, United States, 30265
Not Yet Recruiting
22
Research Site
Chicago, Illinois, United States, 60637
Not Yet Recruiting
23
Research Site
Niles, Illinois, United States, 60714
Not Yet Recruiting
24
Research Site
Zion, Illinois, United States, 60099
Not Yet Recruiting
25
Research Site
Indianapolis, Indiana, United States, 46260
Not Yet Recruiting
26
Research Site
Waukee, Iowa, United States, 50263
Not Yet Recruiting
27
Research Site
Lexington, Kentucky, United States, 40536
Not Yet Recruiting
28
Research Site
Louisville, Kentucky, United States, 40207
Not Yet Recruiting
29
Research Site
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
30
Research Site
Burlington, Massachusetts, United States, 01803
Not Yet Recruiting
31
Research Site
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
32
Research Site
Burnsville, Minnesota, United States, 55337
Not Yet Recruiting
33
Research Site
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
34
Research Site
Kansas City, Missouri, United States, 64132
Not Yet Recruiting
35
Research Site
St Louis, Missouri, United States, 63110
Not Yet Recruiting
36
Research Site
Camden, New Jersey, United States, 08103
Not Yet Recruiting
37
Research Site
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
38
Research Site
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
39
Research Site
Summit, New Jersey, United States, 07901
Not Yet Recruiting
40
Research Site
New York, New York, United States, 10029
Withdrawn
41
Research Site
New York, New York, United States, 10032
Not Yet Recruiting
42
Research Site
New York, New York, United States, 10065
Not Yet Recruiting
43
Research Site
The Bronx, New York, United States, 10461
Not Yet Recruiting
44
Research Site
The Bronx, New York, United States, 10468
Not Yet Recruiting
45
Research Site
White Plains, New York, United States, 10601
Withdrawn
46
Research Site
Winston-Salem, North Carolina, United States, 27103
Not Yet Recruiting
47
Research Site
Cleveland, Ohio, United States, 44195
Withdrawn
48
Research Site
Columbus, Ohio, United States, 43221
Not Yet Recruiting
49
Research Site
Portland, Oregon, United States, 97213
Not Yet Recruiting
50
Research Site
Portland, Oregon, United States, 97239
Not Yet Recruiting
51
Research Site
Hershey, Pennsylvania, United States, 17033
Not Yet Recruiting
52
Research Site
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
53
Research Site
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
54
Research Site
Pittsburgh, Pennsylvania, United States, 15240
Not Yet Recruiting
55
Research Site
Wilkes-Barre, Pennsylvania, United States, 18711
Not Yet Recruiting
56
Research Site
Sioux Falls, South Dakota, United States, 57105
Not Yet Recruiting
57
Research Site
Memphis, Tennessee, United States, 38104
Withdrawn
58
Research Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
59
Research Site
Dallas, Texas, United States, 75246
Not Yet Recruiting
60
Research Site
Sherman, Texas, United States, 75090
Not Yet Recruiting
61
Research Site
Blacksburg, Virginia, United States, 24060
Not Yet Recruiting
62
Research Site
Fairfax, Virginia, United States, 22031
Not Yet Recruiting
63
Research Site
Falls Church, Virginia, United States, 22042
Withdrawn
64
Research Site
Fort Belvoir, Virginia, United States, 22060
Not Yet Recruiting
65
Research Site
Richmond, Virginia, United States, 23219
Not Yet Recruiting
66
Research Site
Olympia, Washington, United States, 98502
Not Yet Recruiting
67
Research Site
Seattle, Washington, United States, 98104
Not Yet Recruiting
68
Research Site
Charleston, West Virginia, United States, 25315
Not Yet Recruiting
69
Research Site
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
70
Research Site
Darlinghurst, Australia, 2010
Suspended
71
Research Site
Garran, Australia, 2605
Suspended
72
Research Site
Heidelberg, Australia, 3084
Not Yet Recruiting
73
Research Site
Murdoch, Australia, 6150
Actively Recruiting
74
Research Site
Randwick, Australia, 2031
Actively Recruiting
75
Research Site
Westmead, Australia, 2145
Actively Recruiting
76
Research Site
Linz, Austria, 4010
Withdrawn
77
Research Site
Rankweil, Austria, 6830
Withdrawn
78
Research Site
Vienna, Austria, 1090
Withdrawn
79
Research Site
Wiener Neustadt, Austria, 2700
Withdrawn
80
Research Site
Brussels, Belgium, 1200
Not Yet Recruiting
81
Research Site
Edegem, Belgium, 2650
Not Yet Recruiting
82
Research Site
Ghent, Belgium, 9000
Not Yet Recruiting
83
Research Site
Leuven, Belgium, 3000
Not Yet Recruiting
84
Research Site
Barretos, Brazil, 14784-400
Not Yet Recruiting
85
Research Site
Fortaleza, Brazil, 60336-045
Not Yet Recruiting
86
Research Site
Natal, Brazil, 59075-740
Not Yet Recruiting
87
Research Site
Porto Alegre, Brazil, 91350200
Not Yet Recruiting
88
Research Site
Salvador, Brazil, 41.950-610
Not Yet Recruiting
89
Research Site
Santa Maria, Brazil, 97015-450
Not Yet Recruiting
90
Research Site
São Paulo, Brazil, 01246-000
Not Yet Recruiting
91
Research Site
Vitória, Brazil, 29043-260
Not Yet Recruiting
92
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Not Yet Recruiting
93
Research Site
Abbotsford British Columbia, British Columbia, Canada, V2S0C2
Not Yet Recruiting
94
Research Site
Vancouver, British Columbia, Canada, VSZ 4E6
Not Yet Recruiting
95
Research Site
Winnipeg, Manitoba, Canada, R3E 0V9
Withdrawn
96
Research Site
Moncton, New Brunswick, Canada, E1C 2Z3
Not Yet Recruiting
97
Research Site
Brampton, Ontario, Canada, L6R 3J7
Actively Recruiting
98
Research Site
Ottawa, Ontario, Canada, K1H 8L6
Not Yet Recruiting
99
Research Site
Sault Ste. Marie, Ontario, Canada, P6A 0A8
Not Yet Recruiting
100
Research Site
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
101
Research Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
102
Research Site
Montreal, Quebec, Canada, H3A 1A1
Actively Recruiting
103
Research Site
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
104
Research Site
Beijing, China, 100032
Actively Recruiting
105
Research Site
Beijing, China, 100050
Not Yet Recruiting
106
Research Site
Beijing, China, 100142
Actively Recruiting
107
Research Site
Beijing, China, 102200
Not Yet Recruiting
108
Research Site
Changde, China, 415000
Not Yet Recruiting
109
Research Site
Chengdu, China, 610041
Not Yet Recruiting
110
Research Site
Chongqing, China, 400016
Not Yet Recruiting
111
Research Site
Fuzhou, China, 350005
Not Yet Recruiting
112
Research Site
Fuzhou, China, 350011
Not Yet Recruiting
113
Research Site
Guangzhou, China, 510655
Not Yet Recruiting
114
Research Site
Hangzhou, China, 310003
Not Yet Recruiting
115
Research Site
Hangzhou, China, 310014
Not Yet Recruiting
116
Research Site
Hangzhou, China, 310020
Not Yet Recruiting
117
Research Site
Harbin, China, 150081
Not Yet Recruiting
118
Research Site
Hefei, China, 230031
Not Yet Recruiting
119
Research Site
Hohhot, China, 010020
Not Yet Recruiting
120
Research Site
Jinan, China, 2501117
Not Yet Recruiting
121
Research Site
Kunming, China, 650118
Not Yet Recruiting
122
Research Site
Lanzhou, China, 730000
Not Yet Recruiting
123
Research Site
Linhai, China, 317000
Not Yet Recruiting
124
Research Site
Linyi, China, 276000
Not Yet Recruiting
125
Research Site
Nanchang, China, 330000
Not Yet Recruiting
126
Research Site
Nanchang, China, 330029
Not Yet Recruiting
127
Research Site
Nanjing, China, 2100008
Not Yet Recruiting
128
Research Site
Nanjing, China, 210029
Not Yet Recruiting
129
Research Site
Nanning, China, 530021
Not Yet Recruiting
130
Research Site
Nantong, China, 226361
Not Yet Recruiting
131
Research Site
Shanghai, China, 200025
Not Yet Recruiting
132
Research Site
Shanghai, China, 200127
Not Yet Recruiting
133
Research Site
Shanghai, China, 20032
Not Yet Recruiting
134
Research Site
Shantou, China, 515041
Not Yet Recruiting
135
Research Site
Shenyang, China, 110016
Not Yet Recruiting
136
Research Site
Shenzhen, China, 518036
Not Yet Recruiting
137
Research Site
Tianjin, China, 300050
Not Yet Recruiting
138
Research Site
Wuhan, China, 430030
Not Yet Recruiting
139
Research Site
Wuhan, China, 430079
Not Yet Recruiting
140
Research Site
Xi'an, China, 710068
Not Yet Recruiting
141
Research Site
Xiamen, China, 361003
Not Yet Recruiting
142
Research Site
Xingtai, China, 054031
Not Yet Recruiting
143
Research Site
Xuzhou, China, 221009
Not Yet Recruiting
144
Research Site
Yinchuan, China, 750004
Not Yet Recruiting
145
Research Site
Zhengzhou, China, 450008
Not Yet Recruiting
146
Research Site
Bordeaux, France, 33000
Not Yet Recruiting
147
Research Site
Caen, France, 41076
Not Yet Recruiting
148
Research Site
Lyon, France, 69373
Not Yet Recruiting
149
Research Site
Marseille, France, 13273
Not Yet Recruiting
150
Research Site
Rennes, France, 35000
Not Yet Recruiting
151
Research Site
Villejuif, France, 94805
Not Yet Recruiting
152
Research Site
Augsburg, Germany, 86156
Not Yet Recruiting
153
Research Site
Berlin, Germany, 13353
Not Yet Recruiting
154
Research Site
Bonn, Germany, 53127
Not Yet Recruiting
155
Research Site
Essen, Germany, 45122
Not Yet Recruiting
156
Research Site
Frankfurt, Germany, 60488
Not Yet Recruiting
157
Research Site
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
158
Research Site
Hamburg, Germany, 20249
Not Yet Recruiting
159
Research Site
Heidelberg, Germany, 69120
Withdrawn
160
Research Site
Heilbronn, Germany, 74078
Not Yet Recruiting
161
Research Site
Leipzig, Germany, 04103
Not Yet Recruiting
162
Research Site
Mainz, Germany, 55131
Not Yet Recruiting
163
Research Site
Mannheim, Germany, 68167
Withdrawn
164
Research Site
Moers, Germany, 47441
Not Yet Recruiting
165
Research Site
München, Germany, 81657
Not Yet Recruiting
166
Research Site
Stuttgart, Germany, 70376
Not Yet Recruiting
167
Research Site
Ulm, Germany, 89081
Not Yet Recruiting
168
Research Site
Budapest, Hungary, 1083
Not Yet Recruiting
169
Research Site
Budapest, Hungary, 1122
Not Yet Recruiting
170
Research Site
Debrecen, Hungary, 4032
Not Yet Recruiting
171
Research Site
Győr, Hungary, 9024
Not Yet Recruiting
172
Research Site
Gyula, Hungary, 5700
Not Yet Recruiting
173
Research Site
Nyíregyháza, Hungary, 4400
Not Yet Recruiting
174
Research Site
Pécs, Hungary, 7624
Not Yet Recruiting
175
Research Site
Zalaegerszeg, Hungary, 8900
Not Yet Recruiting
176
Research Site
Ahmedabad, India, 380060
Not Yet Recruiting
177
Research Site
Bhubaneswar, India, 751019
Not Yet Recruiting
178
Research Site
Hyderabad, India, 500032
Not Yet Recruiting
179
Research Site
Mohali, India, 160055
Not Yet Recruiting
180
Research Site
Mumbai, India, 400012
Not Yet Recruiting
181
Research Site
New Delhi, India, 110017
Not Yet Recruiting
182
Research Site
New Delhi, India, 110060
Withdrawn
183
Research Site
Varanasi, India, 221005
Withdrawn
184
Research Site
Vijayawada, India, 520002
Not Yet Recruiting
185
Research Site
Meldola, Italy, 47014
Not Yet Recruiting
186
Research Site
Milan, Italy, 20133
Not Yet Recruiting
187
Research Site
Milan, Italy, 20141
Not Yet Recruiting
188
Research Site
Milan, Italy, 20162
Not Yet Recruiting
189
Research Site
Padova, Italy, 35128
Not Yet Recruiting
190
Research Site
Rozzano, Italy, 20089
Not Yet Recruiting
191
Research Site
Tricase, Italy, 73039
Not Yet Recruiting
192
Research Site
Chūōku, Japan, 104-0045
Not Yet Recruiting
193
Research Site
Hirakata-shi, Japan, 573-1191
Not Yet Recruiting
194
Research Site
Kashiwa, Japan, 277-8577
Actively Recruiting
195
Research Site
Kitaadachi-gun, Japan, 362-0806
Not Yet Recruiting
196
Research Site
Kōtoku, Japan, 135-8550
Not Yet Recruiting
197
Research Site
Kurashiki-shi, Japan, 710-8602
Not Yet Recruiting
198
Research Site
Nagoya, Japan, 464-8681
Not Yet Recruiting
199
Research Site
Niigata, Japan, 951-8566
Not Yet Recruiting
200
Research Site
Osaka, Japan, 541-8567
Not Yet Recruiting
201
Research Site
Ota-shi, Japan, 373-8550
Not Yet Recruiting
202
Research Site
Sakai, Japan, 590-0197
Not Yet Recruiting
203
Research Site
Sendai, Japan, 980-8574
Not Yet Recruiting
204
Research Site
Sunto-gun, Japan, 411-8777
Not Yet Recruiting
205
Research Site
Yokohama, Japan, 232-0024
Not Yet Recruiting
206
Research Site
Yokohama, Japan, 241-8515
Not Yet Recruiting
207
Research Site
Groningen, Netherlands, 9713 GZ
Not Yet Recruiting
208
Research Site
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
209
Research Site
Tilburg, Netherlands, 5022 GC
Not Yet Recruiting
210
Research Site
Gdansk, Poland, 80-219
Not Yet Recruiting
211
Research Site
Koszalin, Poland, 75-581
Not Yet Recruiting
212
Research Site
Krakow, Poland, 31-501
Not Yet Recruiting
213
Research Site
Lublin, Poland, 20-080
Not Yet Recruiting
214
Research Site
Olsztyn, Poland, 10-228
Not Yet Recruiting
215
Research Site
Warsaw, Poland, 02-034
Not Yet Recruiting
216
Research Site
San Juan, Puerto Rico, 00921
Not Yet Recruiting
217
Research Site
Daegu, South Korea, 41404
Not Yet Recruiting
218
Research Site
Hwasun-gun, South Korea, 58128
Not Yet Recruiting
219
Research Site
Seongnam-si, South Korea, 13620
Not Yet Recruiting
220
Research Site
Seoul, South Korea, 03080
Not Yet Recruiting
221
Research Site
Seoul, South Korea, 03722
Not Yet Recruiting
222
Research Site
Seoul, South Korea, 05505
Not Yet Recruiting
223
Research Site
Seoul, South Korea, 06351
Not Yet Recruiting
224
Research Site
Seoul, South Korea, 06591
Not Yet Recruiting
225
Research Site
Barcelona, Spain, 08035
Not Yet Recruiting
226
Research Site
Barcelona, Spain, 8036
Not Yet Recruiting
227
Research Site
Madrid, Spain, 28041
Not Yet Recruiting
228
Research Site
Pamplona, Spain, 31008
Not Yet Recruiting
229
Research Site
Santander, Spain, 39008
Not Yet Recruiting
230
Research Site
Santiago de Compostela, Spain, 15706
Not Yet Recruiting
231
Research Site
Valencia, Spain, 46010
Not Yet Recruiting
232
Research Site
Kaohsiung City, Taiwan, 80756
Actively Recruiting
233
Research Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
234
Research Site
Taichung, Taiwan, 40447
Actively Recruiting
235
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
236
Research Site
Tainan, Taiwan, 704
Not Yet Recruiting
237
Research Site
Taipei, Taiwan, 10002
Not Yet Recruiting
238
Research Site
Taipei, Taiwan, 112
Actively Recruiting
239
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
240
Research Site
Bangkok, Thailand, 10210
Not Yet Recruiting
241
Research Site
Bangkok, Thailand, 10700
Not Yet Recruiting
242
Research Site
Dusit, Thailand, 10300
Not Yet Recruiting
243
Research Site
Hat Yai, Thailand, 90110
Not Yet Recruiting
244
Research Site
Khon Kaen, Thailand, 40002
Not Yet Recruiting
245
Research Site
Muang, Thailand, 22000
Not Yet Recruiting
246
Research Site
Muang, Thailand, 70000
Not Yet Recruiting
247
Research Site
Ankara, Turkey (Türkiye), 06530
Not Yet Recruiting
248
Research Site
Antalya, Turkey (Türkiye), 07100
Not Yet Recruiting
249
Research Site
Istanbul, Turkey (Türkiye), 34098
Not Yet Recruiting
250
Research Site
Istanbul, Turkey (Türkiye), 34854
Not Yet Recruiting
251
Research Site
Medreseboğazı, Turkey (Türkiye), 01250
Not Yet Recruiting
252
Research Site
Şahinbey, Turkey (Türkiye), 27310
Not Yet Recruiting
253
Research Site
Cambridge, United Kingdom, CB2 0QQ
Not Yet Recruiting
254
Research Site
Dundee, United Kingdom, DD1 9SY
Not Yet Recruiting
255
Research Site
Leeds, United Kingdom, LS9 7TF
Not Yet Recruiting
256
Research Site
London, United Kingdom, EC1A 7BE
Not Yet Recruiting
257
Research Site
Manchester, United Kingdom, M20 4BX
Not Yet Recruiting
258
Research Site
Oxford, United Kingdom, OX3 7LE
Not Yet 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
5
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