Actively Recruiting
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
Led by AstraZeneca · Updated on 2026-05-14
620
Participants Needed
270
Research Sites
248 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 T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
CONDITIONS
Official Title
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 years or older at consent
- Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma
- Prior perioperative or adjuvant treatment allowed if completed more than 90 days before advanced disease diagnosis
- Histologically confirmed HER2-expressing biliary tract cancer (IHC 3+ or IHC 2+)
- Provision of a tumor sample no older than 3 years for central HER2 and PD-L1 testing
- At least one target lesion measurable by RECIST v1.1 (for randomized portion)
- WHO/ECOG performance status of 0 or 1 without recent deterioration
- Adequate organ and bone marrow function within 14 days before randomization
- Post-menopausal status or negative pregnancy test for females of childbearing potential
- Minimum life expectancy of 12 weeks
You will not qualify if you...
- Prior treatment with HER2-targeting therapies, antibody-drug conjugates, immune checkpoint inhibitors, or cancer vaccines
- Diagnosis of ampullary carcinoma
- Significant cardiac or psychological conditions interfering with study participation
- Untreated or symptomatic central nervous system metastases requiring corticosteroids or anticonvulsants
- Recent (within 6 months) myocardial infarction, symptomatic heart failure (NYHA Class II-IV), unstable angina, serious arrhythmias, or recent cardiovascular events including stroke
- Serious chronic gastrointestinal conditions with diarrhea or active non-infectious skin diseases requiring systemic treatment
- Active autoimmune, connective tissue, or inflammatory disorders needing systemic treatment within 2 years or with pulmonary involvement
- Corrected QT interval prolongation over specified thresholds by gender
- History or current interstitial lung disease or pneumonitis, or suspected cases not ruled out by imaging
- Significant lung diseases including recent pulmonary embolism, severe asthma, COPD, restrictive lung disease, or pleural effusion
- Prior complete pneumonectomy
- Uncontrolled infection requiring intravenous antimicrobial therapy
- Active primary immunodeficiency or uncontrolled active HIV or hepatitis C infection
- History of another primary cancer except certain low-risk or treated cancers within 3 years
- Pleural, pericardial, or ascitic effusions requiring drainage or special therapies within 2 weeks before screening
- Concurrent anticancer treatments without adequate washout, except hormonal therapy for non-cancer conditions
- History of organ or allogeneic stem cell transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 270 locations
1
Research Site
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Research Site
Tucson, Arizona, United States, 85704
Withdrawn
3
Research Site
Tucson, Arizona, United States, 85719
Not Yet Recruiting
4
Research Site
Fullerton, California, United States, 92835
Actively Recruiting
5
Research Site
La Jolla, California, United States, 92093
Actively Recruiting
6
Research Site
Los Alamitos, California, United States, 90720
Suspended
7
Research Site
Los Angeles, California, United States, 90017
Actively Recruiting
8
Research Site
Los Angeles, California, United States, 90089
Actively Recruiting
9
Research Site
San Francisco, California, United States, 94143
Actively Recruiting
10
Research Site
Walnut Creek, California, United States, 94598
Not Yet Recruiting
11
Research Site
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
12
Research Site
Fort Myers, Florida, United States, 33901
Actively Recruiting
13
Research Site
Jacksonville, Florida, United States, 32224
Actively Recruiting
14
Research Site
St. Petersburg, Florida, United States, 33705
Actively Recruiting
15
Research Site
Tampa, Florida, United States, 33606
Not Yet Recruiting
16
Research Site
West Palm Beach, Florida, United States, 33401
Actively Recruiting
17
Research Site
Atlanta, Georgia, United States, 30309
Actively Recruiting
18
Research Site
Coeur d'Alene, Idaho, United States, 83814
Withdrawn
19
Research Site
Chicago, Illinois, United States, 60612
Actively Recruiting
20
Research Site
Niles, Illinois, United States, 60714
Actively Recruiting
21
Research Site
Towson, Maryland, United States, 21204
Actively Recruiting
22
Research Site
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
23
Research Site
Worcester, Massachusetts, United States, 01655
Withdrawn
24
Research Site
Detroit, Michigan, United States, 48202
Withdrawn
25
Research Site
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
26
Research Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
27
Research Site
Kansas City, Missouri, United States, 64132
Actively Recruiting
28
Research Site
St Louis, Missouri, United States, 63110
Actively Recruiting
29
Research Site
Albuquerque, New Mexico, United States, 87102
Withdrawn
30
Research Site
New York, New York, United States, 10032
Withdrawn
31
Research Site
White Plains, New York, United States, 10601
Actively Recruiting
32
Research Site
Cleveland, Ohio, United States, 44111
Suspended
33
Research Site
Cleveland, Ohio, United States, 44124
Suspended
34
Research Site
Cleveland, Ohio, United States, 44195
Actively Recruiting
35
Research Site
Columbus, Ohio, United States, 43210
Actively Recruiting
36
Research Site
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
37
Research Site
Greenville, South Carolina, United States, 29605
Actively Recruiting
38
Research Site
Nashville, Tennessee, United States, 37203
Withdrawn
39
Research Site
Austin, Texas, United States, 78705
Withdrawn
40
Research Site
Dallas, Texas, United States, 75246
Actively Recruiting
41
Research Site
Fort Worth, Texas, United States, 76104
Withdrawn
42
Research Site
Fort Worth, Texas, United States, 76104
Actively Recruiting
43
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
44
Research Site
Pearland, Texas, United States, 77584
Withdrawn
45
Research Site
San Antonio, Texas, United States, 78217
Withdrawn
46
Research Site
San Antonio, Texas, United States, 78258
Withdrawn
47
Research Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
48
Research Site
Fairfax, Virginia, United States, 22031
Not Yet Recruiting
49
Research Site
Chermside, Australia, 4032
Actively Recruiting
50
Research Site
Clayton, Australia, 3168
Actively Recruiting
51
Research Site
Concord, Australia, 2139
Actively Recruiting
52
Research Site
Nedlands, Australia, 6009
Actively Recruiting
53
Research Site
Graz, Austria, 8036
Actively Recruiting
54
Research Site
Linz, Austria, 4010
Actively Recruiting
55
Research Site
Salzburg, Austria, 5020
Not Yet Recruiting
56
Research Site
Vienna, Austria, 1090
Actively Recruiting
57
Research Site
Wiener Neustadt, Austria, 2700
Not Yet Recruiting
58
Research Site
Anderlecht, Belgium, 1070
Actively Recruiting
59
Research Site
Edegem, Belgium, 2650
Actively Recruiting
60
Research Site
Ghent, Belgium, 9000
Actively Recruiting
61
Research Site
Leuven, Belgium, 3000
Actively Recruiting
62
Research Site
Liège, Belgium, 4000
Actively Recruiting
63
Research Site
Roeselare, Belgium, 8800
Actively Recruiting
64
Research Site
Natal, Brazil, 59012-300
Actively Recruiting
65
Research Site
Porto Alegre, Brazil, 90035-000
Actively Recruiting
66
Research Site
Porto Alegre, Brazil, 91350-200
Actively Recruiting
67
Research Site
Santa Maria, Brazil, 97015-450
Actively Recruiting
68
Research Site
São Paulo, Brazil, 01246-000
Actively Recruiting
69
Research Site
São Paulo, Brazil, 05651-901
Actively Recruiting
70
Research Site
Vitória, Brazil, 29043-272
Actively Recruiting
71
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
72
Research Site
Halifax, Nova Scotia, Canada, B3H 1V7
Actively Recruiting
73
Research Site
Brampton, Ontario, Canada, L6R 3J7
Actively Recruiting
74
Research Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
75
Research Site
Montreal, Quebec, Canada, H3A 1A1
Actively Recruiting
76
Research Site
Beijing, China, 100020
Actively Recruiting
77
Research Site
Beijing, China, 100021
Withdrawn
78
Research Site
Beijing, China, 100034
Actively Recruiting
79
Research Site
Beijing, China, 100142
Actively Recruiting
80
Research Site
Beijing, China
Actively Recruiting
81
Research Site
Bengbu, China, 233004
Actively Recruiting
82
Research Site
Changchun, China, 130021
Actively Recruiting
83
Research Site
Changde, China, 415000
Actively Recruiting
84
Research Site
Changsha, China, 410005
Not Yet Recruiting
85
Research Site
Changsha, China, 410013
Actively Recruiting
86
Research Site
Chengdu, China, 610041
Actively Recruiting
87
Research Site
Chengdu, China, 610078
Actively Recruiting
88
Research Site
Chongqing, China, 400030
Withdrawn
89
Research Site
Fuzhou, China, 350007
Actively Recruiting
90
Research Site
Guangzhou, China, 510080
Actively Recruiting
91
Research Site
Guangzhou, China, 510515
Actively Recruiting
92
Research Site
Guiyang, China, 550044
Actively Recruiting
93
Research Site
Hangzhou, China, 310016
Actively Recruiting
94
Research Site
Harbin, China, 150081
Actively Recruiting
95
Research Site
Hefei, China, 230001
Actively Recruiting
96
Research Site
Hefei, China, 230601
Actively Recruiting
97
Research Site
Jinan, China, 250117
Actively Recruiting
98
Research Site
Kunming, China, 650101
Actively Recruiting
99
Research Site
Linyi, China, 276000
Actively Recruiting
100
Research Site
Luoyang, China, 471000
Actively Recruiting
101
Research Site
Nanchang, China, 330029
Actively Recruiting
102
Research Site
Nanjing, China, 2100008
Actively Recruiting
103
Research Site
Nanning, China, 530021
Actively Recruiting
104
Research Site
Nantong, China, 226001
Actively Recruiting
105
Research Site
Shanghai, China, 200001
Not Yet Recruiting
106
Research Site
Shanghai, China, 201107
Withdrawn
107
Research Site
Shanghai, China, 201114
Actively Recruiting
108
Research Site
Shenyang, China, 110004
Actively Recruiting
109
Research Site
Shenzhen, China, 518116
Not Yet Recruiting
110
Research Site
Tianjin, China, 300060
Actively Recruiting
111
Research Site
Weifang, China, 261000
Actively Recruiting
112
Research Site
Wenzhou, China, 325035
Actively Recruiting
113
Research Site
Wuhan, China, 430079
Actively Recruiting
114
Research Site
Xi'an, China, 710061
Actively Recruiting
115
Research Site
Zhengzhou, China, 450008
Actively Recruiting
116
Research Site
Zhengzhou, China, 450052
Actively Recruiting
117
Research Site
Brno, Czechia, 625 00
Withdrawn
118
Research Site
Brno, Czechia, 656 53
Actively Recruiting
119
Research Site
Hradec Králové, Czechia, 500 05
Actively Recruiting
120
Research Site
Olomouc, Czechia, 77900
Actively Recruiting
121
Research Site
Prague, Czechia, 100 34
Not Yet Recruiting
122
Research Site
Prague, Czechia, 15006
Actively Recruiting
123
Research Site
Brest, France, 29609
Actively Recruiting
124
Research Site
Clichy, France, 92118
Actively Recruiting
125
Research Site
Dijon, France, 21079
Not Yet Recruiting
126
Research Site
Lille, France, 59037
Actively Recruiting
127
Research Site
Lyon, France, 69008
Actively Recruiting
128
Research Site
Lyon, France, 69373
Actively Recruiting
129
Research Site
Marseille, France, 13008
Actively Recruiting
130
Research Site
Montpellier, France, 34295
Actively Recruiting
131
Research Site
Pessac, France, 33604
Actively Recruiting
132
Research Site
Villejuif, France, 94800
Not Yet Recruiting
133
Research Site
Berlin, Germany, 13353
Actively Recruiting
134
Research Site
Bonn, Germany, 53127
Actively Recruiting
135
Research Site
Cologne, Germany, 50937
Actively Recruiting
136
Research Site
Dresden, Germany, 01370
Actively Recruiting
137
Research Site
Frankfurt, Germany, 60488
Actively Recruiting
138
Research Site
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
139
Research Site
Göttingen, Germany, 37075
Actively Recruiting
140
Research Site
Hamburg, Germany, 22763
Actively Recruiting
141
Research Site
Leipzig, Germany, 4103
Actively Recruiting
142
Research Site
Lübeck, Germany, 23538
Actively Recruiting
143
Research Site
München, Germany, 81377, DE
Actively Recruiting
144
Research Site
Ulm, Germany, 89081
Actively Recruiting
145
Research Site
Würzburg, Germany, 97080
Actively Recruiting
146
Research Site
Hong Kong, Hong Kong, 999077
Actively Recruiting
147
Research Site
Shatin, Hong Kong, 00000
Actively Recruiting
148
Research Site
Dehradun, India, 248016
Actively Recruiting
149
Research Site
Delhi, India, 110029
Actively Recruiting
150
Research Site
Delhi, India, 110088
Actively Recruiting
151
Research Site
Kanpur, India, 208001
Actively Recruiting
152
Research Site
Kolkata, India, 700054
Withdrawn
153
Research Site
Kolkata, India, 700094
Actively Recruiting
154
Research Site
Mumbai, India, 400012
Actively Recruiting
155
Research Site
Vadodara, India, 391760
Actively Recruiting
156
Research Site
Varanasi, India, 221005
Withdrawn
157
Research Site
Florence, Italy, 50134
Actively Recruiting
158
Research Site
Milan, Italy, 20132
Actively Recruiting
159
Research Site
Milan, Italy, 20162
Actively Recruiting
160
Research Site
Naples, Italy, 80128
Actively Recruiting
161
Research Site
Naples, Italy, 80131
Actively Recruiting
162
Research Site
Padova, Italy, 35128
Actively Recruiting
163
Research Site
Roma, Italy, 00133
Actively Recruiting
164
Research Site
Rozzano, Italy, 20089
Actively Recruiting
165
Research Site
Tricase, Italy, 73039
Actively Recruiting
166
Research Site
Bunkyō City, Japan, 113-8431
Actively Recruiting
167
Research Site
Bunkyō City, Japan, 113-8603
Actively Recruiting
168
Research Site
Bunkyō City, Japan, 113-8677
Actively Recruiting
169
Research Site
Chiba, Japan, 260-0877
Actively Recruiting
170
Research Site
Fukuyama-shi, Japan, 721-8511
Actively Recruiting
171
Research Site
Hirakata-shi, Japan, 573-1191
Actively Recruiting
172
Research Site
Hiroshima, Japan, 734-8551
Actively Recruiting
173
Research Site
Kanazawa, Japan, 920-8641
Actively Recruiting
174
Research Site
Kashiwa, Japan, 227-8577
Actively Recruiting
175
Research Site
Kawasaki-shi, Japan, 216-8511
Actively Recruiting
176
Research Site
Kita-gun, Japan, 761-0793
Actively Recruiting
177
Research Site
Kitaadachi-gun, Japan, 362-0806
Actively Recruiting
178
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
179
Research Site
Kumamoto, Japan, 860-8556
Actively Recruiting
180
Research Site
Kyoto, Japan, 606-8507
Actively Recruiting
181
Research Site
Maebashi, Japan, 371-8511
Actively Recruiting
182
Research Site
Mitaka-shi, Japan, 181-8611
Actively Recruiting
183
Research Site
Nagoya, Japan, 464-8681
Actively Recruiting
184
Research Site
Nagoya, Japan, 466-8560
Actively Recruiting
185
Research Site
Osaka, Japan, 541-8567
Actively Recruiting
186
Research Site
Osaka, Japan, 545-8586
Actively Recruiting
187
Research Site
Sakaishi, Japan, 591-8025
Actively Recruiting
188
Research Site
Sapporo, Japan, 060-8543
Actively Recruiting
189
Research Site
Sendai, Japan, 980-8574
Actively Recruiting
190
Research Site
Shinjuku-ku, Japan, 160-8582
Actively Recruiting
191
Research Site
Suita, Japan, 565-0871
Actively Recruiting
192
Research Site
Sunto-gun, Japan, 411-8777
Actively Recruiting
193
Research Site
Ube-shi, Japan, 755-8505
Actively Recruiting
194
Research Site
Wakayama, Japan, 641-8510
Actively Recruiting
195
Research Site
Yokohama, Japan, 241-8515
Actively Recruiting
196
Research Site
George Town, Malaysia, 10990
Actively Recruiting
197
Research Site
Johor Bahru, Malaysia, 81100
Actively Recruiting
198
Research Site
Kuala Lumpur, Malaysia, 50586
Actively Recruiting
199
Research Site
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
200
Research Site
Kuching, Malaysia, 93586
Actively Recruiting
201
Research Site
Rotterdam, Netherlands, 3015 GD
Withdrawn
202
Research Site
Cebu City, Philippines, 6000
Not Yet Recruiting
203
Research Site
Makati, Philippines, 1229
Not Yet Recruiting
204
Research Site
Pasig, Philippines, 1605
Not Yet Recruiting
205
Research Site
Quezon City, Philippines, 1112
Not Yet Recruiting
206
Research Site
Bialystok, Poland, 15-027
Actively Recruiting
207
Research Site
Katowice, Poland, 40-514
Actively Recruiting
208
Research Site
Krakow, Poland, 31-501
Actively Recruiting
209
Research Site
Lublin, Poland, 20-080
Actively Recruiting
210
Research Site
Warsaw, Poland, 02-034
Not Yet Recruiting
211
Research Site
Wroclaw, Poland, 50-556
Withdrawn
212
Research Site
Dammam, Saudi Arabia, 31444
Actively Recruiting
213
Research Site
Riyadh, Saudi Arabia, 11426
Not Yet Recruiting
214
Research Site
Riyadh, Saudi Arabia, 11525
Not Yet Recruiting
215
Research Site
Riyadh, Saudi Arabia, 12713
Actively Recruiting
216
Research Site
Banská Bystrica, Slovakia, 974 01
Not Yet Recruiting
217
Research Site
Bratislava, Slovakia, 833 10
Actively Recruiting
218
Research Site
Košice, Slovakia, 041 91
Actively Recruiting
219
Research Site
Martin, Slovakia, 036 59
Actively Recruiting
220
Research Site
Trnava, Slovakia, 917 75
Actively Recruiting
221
Research Site
Busan, South Korea, 48108
Actively Recruiting
222
Research Site
Gyeonggi-do, South Korea, 13620
Actively Recruiting
223
Research Site
Hwasun-gun, South Korea, 58128
Actively Recruiting
224
Research Site
Seongnam-si, South Korea, 13496
Actively Recruiting
225
Research Site
Seoul, South Korea, 03080
Actively Recruiting
226
Research Site
Seoul, South Korea, 05505
Actively Recruiting
227
Research Site
Seoul, South Korea, 06351
Actively Recruiting
228
Research Site
Seoul, South Korea, 06591
Actively Recruiting
229
Research Site
Seoul, South Korea, 120-752
Actively Recruiting
230
Research Site
Barcelona, Spain, 08035
Actively Recruiting
231
Research Site
Madrid, Spain, 28007
Actively Recruiting
232
Research Site
Madrid, Spain, 28040
Actively Recruiting
233
Research Site
Madrid, Spain, 28041
Actively Recruiting
234
Research Site
Málaga, Spain, 29010
Actively Recruiting
235
Research Site
Santander, Spain, 39008
Actively Recruiting
236
Research Site
Kaohsiung City, Taiwan, 00807
Actively Recruiting
237
Research Site
Kaohsiung City, Taiwan, 82445
Actively Recruiting
238
Research Site
Kaohsiung City, Taiwan, 833
Actively Recruiting
239
Research Site
Taichung, Taiwan, 40447
Actively Recruiting
240
Research Site
Taichung, Taiwan, 407219
Actively Recruiting
241
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
242
Research Site
Taipei, Taiwan
Actively Recruiting
243
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
244
Research Site
Bangkok, Thailand, 10400
Actively Recruiting
245
Research Site
Hat Yai, Thailand, 90110
Actively Recruiting
246
Research Site
Khon Kaen, Thailand, 40002
Actively Recruiting
247
Research Site
Muang, Thailand, 50200
Actively Recruiting
248
Research Site
Mueang, Thailand, 47000
Actively Recruiting
249
Research Site
Naimuang, Thailand, 30000
Actively Recruiting
250
Research Site
Ongkharak, Thailand, 26120
Actively Recruiting
251
Research Site
Si Sa Ket, Thailand, 33000
Actively Recruiting
252
Research Site
Altındağ, Turkey (Türkiye), 06230
Actively Recruiting
253
Research Site
Antalya, Turkey (Türkiye), 07100
Actively Recruiting
254
Research Site
Istanbul, Turkey (Türkiye), 34218
Actively Recruiting
255
Research Site
Izmir, Turkey (Türkiye), 35340
Actively Recruiting
256
Research Site
Mezitli, Turkey (Türkiye), 33200
Actively Recruiting
257
Research Site
Yakutiye, Turkey (Türkiye), 25040
Actively Recruiting
258
Research Site
Birmingham, United Kingdom, B15 2GW
Not Yet Recruiting
259
Research Site
Dundee, United Kingdom, DD1 9SY
Not Yet Recruiting
260
Research Site
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
261
Research Site
Greater London, United Kingdom, SW3 6JJ
Not Yet Recruiting
262
Research Site
Leeds, United Kingdom, LS9 7TF
Not Yet Recruiting
263
Research Site
London, United Kingdom, EC1A 7BE
Not Yet Recruiting
264
Research Site
Hanoi, Vietnam, 100000
Actively Recruiting
265
Research Site
Ho Chi Minh City, Vietnam, 700000
Actively Recruiting
266
Research Site
Ho Chi Minh City, Vietnam, 700000
Withdrawn
267
Research Site
Ho Chi Minh City, Vietnam, 700000
Not Yet Recruiting
268
Research Site
Ho Chi Minh City, Vietnam, 70000
Actively Recruiting
269
Research Site
Ho Chi Minh City, Vietnam, 70000
Not Yet Recruiting
270
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
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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