Actively Recruiting
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
Led by AstraZeneca · Updated on 2026-05-13
450
Participants Needed
100
Research Sites
364 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients. Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.
CONDITIONS
Official Title
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants must be at least 18 years of age
- Locally advanced, unresectable, or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma confirmed by recent imaging
- For Parts 1, 2, 3a, and 4a: HER2-positive adenocarcinoma (IHC 3+ or IHC 2+/ISH+) confirmed by local tissue testing
- For Parts 3b, 4b, and 5: HER2-low adenocarcinoma (IHC 2+/ISH-negative or IHC 1+) confirmed by local tissue testing
- For Part 1: disease progressed on or after at least one prior trastuzumab-containing treatment
- For Parts 2, 3, 4, and 5: no prior treatment for unresectable or metastatic disease
- Measurable target disease assessed by the Investigator using RECIST version 1.1
- Adequate bone marrow and organ function, including heart, kidney, and liver function
- If able to have children, agrees to use highly effective contraception or avoid intercourse during and after the study
You will not qualify if you...
- History of active primary immunodeficiency, known HIV, active or past hepatitis B or C infection (Parts 1 to 4); active uncontrolled HIV, HBV, or HCV infection (Part 5)
- Uncontrolled intercurrent illness
- History or current pneumonitis, interstitial lung disease (ILD), or suspected ILD that cannot be ruled out by imaging
- Severe lung-related illnesses
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals
- Pleural effusion, ascites, or pericardial effusion needing drainage or special therapy
- Spinal cord compression or active central nervous system metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 100 locations
1
Research Site
Santa Monica, California, United States, 90404
Withdrawn
2
Research Site
Westwood, Kansas, United States, 66205
Withdrawn
3
Research Site
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
Research Site
Boston, Massachusetts, United States, 02114
Withdrawn
5
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Research Site
Ann Arbor, Michigan, United States, 48109
Withdrawn
7
Research Site
New York, New York, United States, 10065
Actively Recruiting
8
Research Site
Durham, North Carolina, United States, 27710
Withdrawn
9
Research Site
Houston, Texas, United States, 77090
Actively Recruiting
10
Research Site
Fairfax, Virginia, United States, 22031
Withdrawn
11
Research Site
Florianópolis, Brazil, 88020-210
Withdrawn
12
Research Site
Londrina, Brazil, 86015-520
Completed
13
Research Site
Natal, Brazil, 59075-740
Withdrawn
14
Research Site
Porto Alegre, Brazil, 90160-093
Withdrawn
15
Research Site
Ribeirão Preto, Brazil, 14051-140
Completed
16
Research Site
Rio de Janeiro, Brazil, 22793-080
Withdrawn
17
Research Site
Santa Maria, Brazil, 97015-450
Actively Recruiting
18
Research Site
São Jose Do Rio Preto, Brazil, 15090-000
Actively Recruiting
19
Research Site
São Paulo, Brazil, 01509-900
Withdrawn
20
Research Site
São Paulo, Brazil, 03102-002
Withdrawn
21
Research Site
São Paulo, Brazil, 045202-001
Active, Not Recruiting
22
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Withdrawn
23
Research Site
Ottawa, Ontario, Canada, K1H 8L6
Withdrawn
24
Research Site
Toronto, Ontario, Canada, M4N 3M5
Withdrawn
25
Research Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
26
Research Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
27
Research Site
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
28
Research Site
Chengdu, China, 610042
Actively Recruiting
29
Research Site
Guangzhou, China, 510062
Actively Recruiting
30
Research Site
Guiyang, China, 550002
Withdrawn
31
Research Site
Hangzhou, China, 310022
Withdrawn
32
Research Site
Hefei, China, 230001
Actively Recruiting
33
Research Site
Hefei, China, 230601
Withdrawn
34
Research Site
Shanghai, China, 200025
Actively Recruiting
35
Research Site
Shanghai, China, 200031
Withdrawn
36
Research Site
Shanghai, China, 200032
Actively Recruiting
37
Research Site
Shanghai, China, 200050
Withdrawn
38
Research Site
Shenyang, China, 110001
Actively Recruiting
39
Research Site
Ürümqi, China, 830000
Withdrawn
40
Research Site
Wuhan, China, 430000
Actively Recruiting
41
Research Site
Xiamen, China, 361003
Withdrawn
42
Research Site
Zhengzhou, China, 450008
Actively Recruiting
43
Research Site
Frankfurt, Germany, 60488
Actively Recruiting
44
Research Site
Frankfurt, Germany, 60590
Actively Recruiting
45
Research Site
Hamburg, Germany, 20249
Actively Recruiting
46
Research Site
Leipzig, Germany, 04103
Actively Recruiting
47
Research Site
Mannheim, Germany, 68167
Actively Recruiting
48
Research Site
München, Germany, 81675
Actively Recruiting
49
Research Site
Milan, Italy, 20133
Actively Recruiting
50
Research Site
Milan, Italy, 20162
Actively Recruiting
51
Research Site
Naples, Italy, 80131
Actively Recruiting
52
Research Site
Padova, Italy, 35128
Actively Recruiting
53
Research Site
Roma, Italy, 00168
Actively Recruiting
54
Research Site
Verona, Italy, 37134
Actively Recruiting
55
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
56
Research Site
Kashiwa, Japan, 277-8577
Actively Recruiting
57
Research Site
Kita-gun, Japan, 761-0793
Actively Recruiting
58
Research Site
Ota-shi, Japan, 373-8550
Actively Recruiting
59
Research Site
Amsterdam, Netherlands, 1066CX
Actively Recruiting
60
Research Site
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
61
Research Site
Utrecht, Netherlands, 3584CG
Actively Recruiting
62
Research Site
Gdansk, Poland, 80-214
Actively Recruiting
63
Research Site
Konin, Poland, 62-500
Actively Recruiting
64
Research Site
Koszalin, Poland, 75-581
Actively Recruiting
65
Research Site
Krakow, Poland, 31-501
Actively Recruiting
66
Research Site
Lublin, Poland, 20-090
Withdrawn
67
Research Site
Opole, Poland, 45-061
Withdrawn
68
Research Site
Tomaszów Mazowiecki, Poland, 97-200
Withdrawn
69
Research Site
Warsaw, Poland, 02-034
Actively Recruiting
70
Research Site
Kostroma, Russia, 156005
Suspended
71
Research Site
Moscow, Russia, 115478
Suspended
72
Research Site
Moscow, Russia, 125284
Terminated
73
Research Site
Moscow, Russia, 143423
Suspended
74
Research Site
Moscow, Russia, 143442
Terminated
75
Research Site
Novosibirsk, Russia, 630099
Suspended
76
Research Site
Saint Petersburg, Russia, 195271
Completed
77
Research Site
Saint Petersburg, Russia, 196603
Suspended
78
Research Site
Saint Petersburg, Russia, 197022
Suspended
79
Research Site
Saint Petersburg, Russia, 197758
Completed
80
Research Site
Seongnam-si, South Korea, 13620
Actively Recruiting
81
Research Site
Seoul, South Korea, 03080
Actively Recruiting
82
Research Site
Seoul, South Korea, 03722
Actively Recruiting
83
Research Site
Seoul, South Korea, 05505
Actively Recruiting
84
Research Site
Seoul, South Korea, 06351
Actively Recruiting
85
Research Site
Barcelona, Spain, 08035
Actively Recruiting
86
Research Site
Madrid, Spain, 28007
Actively Recruiting
87
Research Site
Madrid, Spain, 28034
Actively Recruiting
88
Research Site
Santander, Spain, 39008
Actively Recruiting
89
Research Site
Seville, Spain, 41013
Actively Recruiting
90
Research Site
Kaohsiung City, Taiwan, 80756
Actively Recruiting
91
Research Site
Kaohsiung City, Taiwan, 83301
Withdrawn
92
Research Site
Tainan, Taiwan, 704
Actively Recruiting
93
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
94
Research Site
Taipei, Taiwan, 11217
Actively Recruiting
95
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
96
Research Site
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
97
Research Site
Dundee, United Kingdom, DD1 9SY
Actively Recruiting
98
Research Site
London, United Kingdom, NW1 2PG
Actively Recruiting
99
Research Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
100
Research Site
Sutton, United Kingdom, SM2 5PT
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
18
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