NCT registry number
Author, name
country
phase
Treatment regimen
Sample size
age
Primary tumor type (GC/GEJC)
HER2 expression status
ORR
DCR
mOS (months) mPFS (months)
Any grade AEs
Grade≥3 AEs
NCT02564900
Shitara 2019
USA, Japan
I
T-DXd
44
68.0 (62.5-72.0)
36/8
positive
19 (43%) 35 (80%) 12.8 (1.4–25.4) 5.6 (3.0-8.3) 44 (100%) 28 (63.6%)
NCT03329690
Shitara 2020
Japan, South Korea
II
T-DXd/PC
125
65 (34-82)
108/17
positive
51 (43%) 102 (82%) 12.5 (9.6–14.3) 5.6 (4.3-6.9) 125 (100%) 107 (85.6%)
NCT04014075
Cutsem 2023
USA, Europe
II
T-DXd
79
60.7 (52.0–68.3)
27/52
positive
33 (42%) 64 (81%) 12.1 (9.4-15.4) 5.6 (4.2-8.3) 79 (100%) 44 (55.7%)
NCT02277717
Banerji 2019
Belgium, the Netherlands, Spain, the UK.
I
SYD985
17
61 (52-68)
17/0
positive
1 (6%)
-
-
3.2 (1.6-5.3)
-
-
NCT03556345
Peng 2021
China
II
RC48
125
58 (24-70)
97/28
positive
31 (25%) 53 (42%) 7.9 (6.7-9.9) 4.1 (3.7-4.9) 218 (97.3%) 134 (59.8%)
NCT01641939
Peter 2017
28 countries
II/III
T-DM1
228
62.0 (19-79)
151/77
positive
42 (21%)
-
7.9 (6.7-9.5) 2.7 (1.6-2.7) 218 (97.3%) 134 (59.8%)
CTR20190639
Zhang 2022
China
I
ARX788
30
57 (26–72)
22/8
positive
11 (38%) 16 (55%) 10.7 (4.8–NR) 4.1 (1.4-6.4) 28 (93.3%) 4 (13.3%)
NCT03329690
Yamaguchi 2023 Cohort 1 Japan, South Korea
II
T-DXd
20
64.0 (29-74)
16/4
low
5 (26%) 17 (89%) 7.8 (4.7-NR) 4.4 (2.7-7.1) 20 (100%) 14 (70.0%)
NCT03329690
Yamaguchi 2023 Cohort 2 Japan, South Korea
II
T-DXd
24
58.5 (30-72)
22/2
low
2 (10%) 15 (71%) 8.5 (4.3-10.9) 2.8 (1.5-4.3) 24 (100%) 19 (79.2%)